How is the progress of Taiwan chemical regulations? How are the Taiwan Customs supervision measures going? What are the differences between Pre-Registration and Late Pre-Registration? What about the CBI protection under Taiwan chemical regulations? Experts from CIRS will make interpretations of all the above mentioned contents and will bring you some take home messages for enterprises.
New Product Registration - Key Considerations when Registering New ProductsCovance
The regulation related to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) was adopted by the EU in 2007 in response to worldwide initiatives to address the impact of chemicals on human health and the environment. REACH requires all manufacturers and importers of chemicals into European markets to assess and manage the risks associated with their substances and products, and register them with the European Chemicals Agency (ECHA). To manage this project, ECHA split existing substances into three categories, based on the amount of the substance that is used annually, with different registration deadlines for different tonnages of use.
K-REACH - How to Prepare for the K-REACH LegislationCovance
In 2015, South Korea introduced legislation designed to protect human health and the environment from the impact of chemicals. The two pieces of legislation introduced were the: Act on the Registration and Evaluation of Chemicals (K-REACH), which mandates the registration of all new and existing chemicals marketed or imported into South Korea at ≥1 metric ton per year, requiring detailed information on their likely hazard to human health and the environment and the Chemicals Control Act (CCA), which focuses on chemical reporting and chemical accident prevention.
This document provides an overview of China's food import regulations and procedures. It discusses China's regulatory framework and the various government bodies involved in food regulation. It then outlines the key steps involved in the importation process, including customs registration, AQSIQ filing, CIQ inspection, and post-import monitoring requirements. It also discusses additional approvals needed for special types of foods, such as new food products, foods with health claims, and foods for special dietary uses. Approvals for new foods involve toxicology testing and demonstration of prior safe use to obtain approval.
The document discusses various organic certification seals used internationally, nationally, and privately. It outlines certification seals used in China, the US, European Union, France, Canada, Japan, Australia, and Germany. It then provides details on the international certification organizations Quality Assurance International (QAI), China Organic Food Certification Center (COFCC), and ECOCERT China. It concludes by describing IFOAM as the worldwide umbrella organization for the organic movement, with over 750 member organizations in 116 countries.
Pira 2009 Sept. Arlington Taiwan New Chemical Regulation2globalchemreg
The document summarizes Taiwan's new chemicals control regulation which aims to construct a Taiwan Existing Chemicals List and establish procedures for new chemicals notification and nomination. It outlines key details of the new regulation including nomination of existing chemicals by July 2010, building of the chemicals list by July 2011, and new chemicals notification requirements starting July 2011. Manufacturers and importers are advised to start preparing now by nominating their existing chemical substances and finding local contacts in Taiwan.
This document summarizes the key impacts of China's new Food Safety Law on infant formula, health foods, and special dietary foods. It discusses increased regulations for infant formula, including whole process quality control, product registration, and restrictions on sub-packaging and using the same formula for different brands. It also outlines the import process for infant formula and challenges import companies may face, such as ensuring formulas are registered and formulations comply with local policies.
The document provides guidance on developing a Global Chemical Industry Compliance Programme (GC-ICP) to comply with the Chemical Weapons Convention (CWC). It outlines the steps to determine if chemicals at a facility are subject to reporting requirements under the CWC, including identifying the chemical, determining if it is a scheduled chemical or unscheduled discrete organic chemical, and if production/import/export quantities exceed thresholds. The document also provides information on administrative elements of a compliance program such as record keeping, training, and a policy statement.
Animal testing safety endpoints in chemical industryMIHIR PUJARA
This presentation describes animal testing safety end points in chemical industry according to REACH(registration,evaluation,authorisation & restriction of chemicals).
REACH was established to control manufacturing and importing of chemicals in EU market & to minimize the risks to human health and environment.
New Product Registration - Key Considerations when Registering New ProductsCovance
The regulation related to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) was adopted by the EU in 2007 in response to worldwide initiatives to address the impact of chemicals on human health and the environment. REACH requires all manufacturers and importers of chemicals into European markets to assess and manage the risks associated with their substances and products, and register them with the European Chemicals Agency (ECHA). To manage this project, ECHA split existing substances into three categories, based on the amount of the substance that is used annually, with different registration deadlines for different tonnages of use.
K-REACH - How to Prepare for the K-REACH LegislationCovance
In 2015, South Korea introduced legislation designed to protect human health and the environment from the impact of chemicals. The two pieces of legislation introduced were the: Act on the Registration and Evaluation of Chemicals (K-REACH), which mandates the registration of all new and existing chemicals marketed or imported into South Korea at ≥1 metric ton per year, requiring detailed information on their likely hazard to human health and the environment and the Chemicals Control Act (CCA), which focuses on chemical reporting and chemical accident prevention.
This document provides an overview of China's food import regulations and procedures. It discusses China's regulatory framework and the various government bodies involved in food regulation. It then outlines the key steps involved in the importation process, including customs registration, AQSIQ filing, CIQ inspection, and post-import monitoring requirements. It also discusses additional approvals needed for special types of foods, such as new food products, foods with health claims, and foods for special dietary uses. Approvals for new foods involve toxicology testing and demonstration of prior safe use to obtain approval.
The document discusses various organic certification seals used internationally, nationally, and privately. It outlines certification seals used in China, the US, European Union, France, Canada, Japan, Australia, and Germany. It then provides details on the international certification organizations Quality Assurance International (QAI), China Organic Food Certification Center (COFCC), and ECOCERT China. It concludes by describing IFOAM as the worldwide umbrella organization for the organic movement, with over 750 member organizations in 116 countries.
Pira 2009 Sept. Arlington Taiwan New Chemical Regulation2globalchemreg
The document summarizes Taiwan's new chemicals control regulation which aims to construct a Taiwan Existing Chemicals List and establish procedures for new chemicals notification and nomination. It outlines key details of the new regulation including nomination of existing chemicals by July 2010, building of the chemicals list by July 2011, and new chemicals notification requirements starting July 2011. Manufacturers and importers are advised to start preparing now by nominating their existing chemical substances and finding local contacts in Taiwan.
This document summarizes the key impacts of China's new Food Safety Law on infant formula, health foods, and special dietary foods. It discusses increased regulations for infant formula, including whole process quality control, product registration, and restrictions on sub-packaging and using the same formula for different brands. It also outlines the import process for infant formula and challenges import companies may face, such as ensuring formulas are registered and formulations comply with local policies.
The document provides guidance on developing a Global Chemical Industry Compliance Programme (GC-ICP) to comply with the Chemical Weapons Convention (CWC). It outlines the steps to determine if chemicals at a facility are subject to reporting requirements under the CWC, including identifying the chemical, determining if it is a scheduled chemical or unscheduled discrete organic chemical, and if production/import/export quantities exceed thresholds. The document also provides information on administrative elements of a compliance program such as record keeping, training, and a policy statement.
Animal testing safety endpoints in chemical industryMIHIR PUJARA
This presentation describes animal testing safety end points in chemical industry according to REACH(registration,evaluation,authorisation & restriction of chemicals).
REACH was established to control manufacturing and importing of chemicals in EU market & to minimize the risks to human health and environment.
Losses due non-compliance with China food regulation and how to overcome Chi...Rong Liu
As the world’s largest imported food market, China imported totally 38 billion US dollars food products from187 countries in 2016.
The growing China market has attracted a lot of interest from different countries over the world. Meanwhile China government has, over the last years, developed a tougher and tougher food regulation regime to regulate the market and ensure food safety.
Due to various challenges (languages, resources, information accessibility etc.), foreign SMEs learned a lot lessons and experienced big losses due to non-compliance with Chinese regulations.
Actually majority of these losses due non-compliance can be easily prevented if SMEs have reliable regulatory information in hand.
As a leading Chinese food regulation consulting company, FoodMate developed “Compliance Excellence” information service product for foreign SMEs with target to minimize your losses due regulatory non-compliance by assessing reliable and tailor made regulatory information.
China has passed a new, stricter Food Safety Law in 2015. Key changes include:
- Stricter penalties for violations, including revoking certificates and banning imports.
- Imported foods must meet Chinese standards and be accompanied by inspection certificates. Importers must verify exporters' compliance.
- Authorities have increased supervision of imported foods in the domestic market and cooperation between agencies.
- Exporters, agents, importers and overseas producers must register with authorities. Those providing false information can be removed from registration lists.
Food Contact & Food Additives_Laura WangLaura Wang
The document summarizes recent developments in China's food additives regulations. It provides an overview of China's food additives regulation system and the major regulatory bodies. It then discusses two key updates: 1) Revisions made to China's Food Safety Law in 2015, including provisions related to risk assessment, standards, production and import requirements for food additives. 2) Revisions made to GB 2760-2014, China's standard for uses of food additives, which consolidated notices, removed sections to be covered by other standards, modified carry-over principles and appendix information.
The document discusses regulatory requirements and standards in India. It notes that the Government of India promulgates regulatory requirements to safeguard health and safety for both domestically produced and imported goods and services. These regulations are established by various ministries and acts, and must comply with WTO agreements. The Bureau of Indian Standards is the national standards body that develops voluntary consensus-based standards, though 68 have been made mandatory. BIS operates certification schemes to ensure conformity and facilitates international cooperation on standards and conformity assessment.
This document discusses international trade and import/export processes and documentation. It defines key terms like trade, international trade, free trade, and trade protectionism. It also outlines the fundamental objectives of regulatory reform. Additionally, it describes important commercial terms like INCOTERMS and provides overviews of the export and import processes, including required documentation for customs clearance. Key steps in the export process include order confirmation, procurement, quality control, packaging, and customs procedures.
FoodMate “Compliance Excellence” to reduce your losses due non-compliance wit...Rong Liu
As the world’s largest imported food market, China imported totally 38 billion US dollars food products from187 countries in 2016.
The growing China market has attracted a lot of interest from different countries over the world. Meanwhile China government has, over the last years, developed a tougher and tougher food regulation regime to regulate the market and ensure food safety.
Due to various challenges (languages, resources, information accessibility etc.), foreign SMEs learned a lot lessons and experienced big losses due to non-compliance with Chinese regulations.
Actually majority of these losses due non-compliance can be easily prevented if SMEs have reliable regulatory information in hand.
As a leading Chinese food regulation consulting company, FoodMate developed “Compliance Excellence” information service product for foreign SMEs with target to minimize your losses due regulatory non-compliance by assessing reliable and tailor made regulatory information.
Export inspection council and APEDA are bodies created by GOI under the Export act to facilitate the agril. export. EIC provides certification while APEDA has main objective to promote the export and exporters
1) The document discusses guidelines for re-evaluating and managing maximum residue limits (MRLs) of pesticides and veterinary drugs in food in Korea.
2) It outlines the process for re-evaluating pesticides MRLs, deleting pesticides that are not registered domestically, and adopting MRLs for imported foods.
3) It also provides questions and answers to clarify the guidelines, such as the process for establishing new MRLs, data submission requirements, and timelines.
GHS Implementation Status Quo in Southeast and East Asian Countries - 2014Jane Zhou
It is well recognized that an internationally harmonized approach to classification of chemicals and hazard communication serves as the foundation of sound chemical management and trade facilitation globally. Currently many Asian countries are implementing GHS guidelines and actively promoting its fundamental tenants. However, the local adaptions of the UN model guidelines, the implementation timelines and the enforcement schemes vary from country to country.
This presentation outlines regulatory developments till Oct, 2014 which are related to GHS implementation in the Philippines, Thailand, Vietnam, Singapore, Malaysia, Indonesia, Taiwan (Chinese Taipei), South Korea and Japan.
For most up-to-date information please visit:
https://ChemLinked.com
Food Safety Modernization Act (FSMA) regulatory requirements by FDABrian Thomas
Food Safety Modernization Act (FSMA) is placing new regulatory demands on food manufacturers and suppliers in the US market. For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply. As key implementation deadlines approach, food manufacturers are shifting from a reactionary to a preventive footing, with stricter controls, documentation, and supplier verification requirements. This means there is a new regulatory world for food producers, including regulations for food-borne illness prevention and traceability. Presentation provides a summary of the new regulations, the risks and challenges faced by food producers, and the opportunities to take action through applications of modern control and information technology.
Overview of Japanese Foreign Manufacturers Accreditationjapan-rs
This document discusses the process for foreign manufacturers to obtain accreditation from the Japanese Ministry of Health, Labour and Welfare to export medical devices to Japan. It outlines the requirements, application process, and fees for initial accreditation, changes to an existing accreditation, renewal of accreditation, and notifications of changes. The accreditation process involves submitting application documents to both the Ministry and the Pharmaceutical and Medical Devices Agency, who reviews facilities and processes to ensure compliance with Japanese regulations.
This document provides an overview and summary of Canada's new Safe Food for Canadians Regulation (SFCR) which comes into effect on January 15, 2019. It outlines the key elements of the new regulation including licensing requirements, preventive control measures, traceability rules, and the steps companies need to take to transition. The regulation aims to modernize and consolidate Canada's food safety rules and better protect consumers from foodborne illness.
Process guidelines for foreign companies exporting infant formula to china(f...Rong Liu
After years of dedicating to Chinese dairy and infant formula market, we have summarized the opportunities& challenges for foreign infant formula companies to enter and stay in China market.
After tracking the related regulations, standards, notices, we also provide you a process guideline as well as regulation mapping regarding Chinese dairy industry especially for infant formula.
We are confident that this document can help foreign manufactures, international traders master the whole and clear picture about Chinese infant formula market from regulatory perspective.
Safe Food for Canadians Regulation – Are You Ready?
The Safe Food Canadians Act is a bit of a ‘sleeping’ giant, as the regulations came into effect January 15, 2019. Many food companies both within Canada and outside its borders are still trying to figure out what they need to do in order to comply.
This informative webinar featuring Cameron Prince with The Acheson Group discusses:
- Top 3 pillars of the Safe Food Canadians Regulations and how they compare to FSMA
- What companies should have in place, or work towards quickly, to ensure compliance – relative to licensing, traceability and preventive controls
- The long term impact these regulations will have on food companies, and predictions on enforcement
Learn more at https://safetychain.com
Import and export regulations laws of usaSanjay Yadav
This document discusses FDA regulations regarding the import and export of medical products. It outlines the authorities FDA has to examine imported foods, drugs, and other products. It provides details on import documentation and entry requirements. It also discusses requirements for exporting over-the-counter drugs and unapproved new drugs in accordance with Section 802 of the Federal Food, Drug, and Cosmetic Act.
This document summarizes the drug approval processes in Europe and India. In Europe, there are four approval procedures - centralized, mutual recognition, decentralized, and national. The centralized procedure provides approval across the European Union and is required for certain drug classes. The other procedures allow approval in multiple or individual European countries. The process involves a clinical trial application, marketing authorization application, assessment reports, and regulatory agency reviews. In India, companies must apply to the Drugs Controller General of India and conduct clinical trials according to Schedule Y guidelines to obtain approval. The process is generally longer in India, taking 12-18 months versus approximately 12 months in Europe. Both regions have stringent requirements for new drug approval and regulate the pharmaceutical industry to protect public health
The document discusses pesticide registration processes and requirements in India. It covers registration under sections 9(3), 9(3B), and 9(4) of the Insecticides Act 1968 for technical manufacture, import, and formulation of insecticides, herbicides, fungicides, and biopesticides. It also discusses registration for export and requirements for enhancement of product shelf life, alternate packaging, and other permits. Primary Information Services provides assistance with registration, dossier preparation, and maintains databases of registered products, companies, patents, and technical data.
This document discusses India's animal quarantine services and their objectives of preventing the introduction of exotic livestock diseases. It outlines the quarantine stations located across India and their economic importance in saving money through disease prevention and increasing exports. Regulations regarding livestock imports and exports are discussed, highlighting the need for mandatory animal quarantine clearance. Proper technical export certification is emphasized as important for increasing trade and meeting international standards.
This document outlines the Self-Monitoring and Reporting Tools by Industry Rules established in 2001 in Pakistan. It classifies industries into categories A, B, and C for reporting frequencies on liquid effluents and gaseous emissions. It also defines key terms, establishes responsibilities for industrial units to submit monitoring reports, outlines report requirements, and lists priority industries in each classification. The rules aim to support enforcement of environmental standards and develop an industry pollution database.
The document provides information on chemical safety, including what chemical substances are, the forms chemicals can take, how chemicals can be hazardous to health, assessing risks from chemical exposure, effects chemicals can have on the body, how chemicals enter the body, and control measures for chemicals including identifying hazards, assessing exposure and risk, implementing engineering and administrative controls, providing training, safely storing and handling chemicals, and using personal protective equipment.
What are new chemical substance regulations in China? And what are toxic chemical substance regulations in China? How to compliant with these regulations? What inventories can be referred? How enterprises to determine their obligations? Answers can be found in CIRS free webinar for chemical regulations & compliance in China.
This webinar will introduce current chemical management regulations in China and how to fulfill enterprises’ obligations under these regulations. Detailed operationwill be summarized here for GHS and regulatory specialist and related stake-holders to well-understand and follow up.
Losses due non-compliance with China food regulation and how to overcome Chi...Rong Liu
As the world’s largest imported food market, China imported totally 38 billion US dollars food products from187 countries in 2016.
The growing China market has attracted a lot of interest from different countries over the world. Meanwhile China government has, over the last years, developed a tougher and tougher food regulation regime to regulate the market and ensure food safety.
Due to various challenges (languages, resources, information accessibility etc.), foreign SMEs learned a lot lessons and experienced big losses due to non-compliance with Chinese regulations.
Actually majority of these losses due non-compliance can be easily prevented if SMEs have reliable regulatory information in hand.
As a leading Chinese food regulation consulting company, FoodMate developed “Compliance Excellence” information service product for foreign SMEs with target to minimize your losses due regulatory non-compliance by assessing reliable and tailor made regulatory information.
China has passed a new, stricter Food Safety Law in 2015. Key changes include:
- Stricter penalties for violations, including revoking certificates and banning imports.
- Imported foods must meet Chinese standards and be accompanied by inspection certificates. Importers must verify exporters' compliance.
- Authorities have increased supervision of imported foods in the domestic market and cooperation between agencies.
- Exporters, agents, importers and overseas producers must register with authorities. Those providing false information can be removed from registration lists.
Food Contact & Food Additives_Laura WangLaura Wang
The document summarizes recent developments in China's food additives regulations. It provides an overview of China's food additives regulation system and the major regulatory bodies. It then discusses two key updates: 1) Revisions made to China's Food Safety Law in 2015, including provisions related to risk assessment, standards, production and import requirements for food additives. 2) Revisions made to GB 2760-2014, China's standard for uses of food additives, which consolidated notices, removed sections to be covered by other standards, modified carry-over principles and appendix information.
The document discusses regulatory requirements and standards in India. It notes that the Government of India promulgates regulatory requirements to safeguard health and safety for both domestically produced and imported goods and services. These regulations are established by various ministries and acts, and must comply with WTO agreements. The Bureau of Indian Standards is the national standards body that develops voluntary consensus-based standards, though 68 have been made mandatory. BIS operates certification schemes to ensure conformity and facilitates international cooperation on standards and conformity assessment.
This document discusses international trade and import/export processes and documentation. It defines key terms like trade, international trade, free trade, and trade protectionism. It also outlines the fundamental objectives of regulatory reform. Additionally, it describes important commercial terms like INCOTERMS and provides overviews of the export and import processes, including required documentation for customs clearance. Key steps in the export process include order confirmation, procurement, quality control, packaging, and customs procedures.
FoodMate “Compliance Excellence” to reduce your losses due non-compliance wit...Rong Liu
As the world’s largest imported food market, China imported totally 38 billion US dollars food products from187 countries in 2016.
The growing China market has attracted a lot of interest from different countries over the world. Meanwhile China government has, over the last years, developed a tougher and tougher food regulation regime to regulate the market and ensure food safety.
Due to various challenges (languages, resources, information accessibility etc.), foreign SMEs learned a lot lessons and experienced big losses due to non-compliance with Chinese regulations.
Actually majority of these losses due non-compliance can be easily prevented if SMEs have reliable regulatory information in hand.
As a leading Chinese food regulation consulting company, FoodMate developed “Compliance Excellence” information service product for foreign SMEs with target to minimize your losses due regulatory non-compliance by assessing reliable and tailor made regulatory information.
Export inspection council and APEDA are bodies created by GOI under the Export act to facilitate the agril. export. EIC provides certification while APEDA has main objective to promote the export and exporters
1) The document discusses guidelines for re-evaluating and managing maximum residue limits (MRLs) of pesticides and veterinary drugs in food in Korea.
2) It outlines the process for re-evaluating pesticides MRLs, deleting pesticides that are not registered domestically, and adopting MRLs for imported foods.
3) It also provides questions and answers to clarify the guidelines, such as the process for establishing new MRLs, data submission requirements, and timelines.
GHS Implementation Status Quo in Southeast and East Asian Countries - 2014Jane Zhou
It is well recognized that an internationally harmonized approach to classification of chemicals and hazard communication serves as the foundation of sound chemical management and trade facilitation globally. Currently many Asian countries are implementing GHS guidelines and actively promoting its fundamental tenants. However, the local adaptions of the UN model guidelines, the implementation timelines and the enforcement schemes vary from country to country.
This presentation outlines regulatory developments till Oct, 2014 which are related to GHS implementation in the Philippines, Thailand, Vietnam, Singapore, Malaysia, Indonesia, Taiwan (Chinese Taipei), South Korea and Japan.
For most up-to-date information please visit:
https://ChemLinked.com
Food Safety Modernization Act (FSMA) regulatory requirements by FDABrian Thomas
Food Safety Modernization Act (FSMA) is placing new regulatory demands on food manufacturers and suppliers in the US market. For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply. As key implementation deadlines approach, food manufacturers are shifting from a reactionary to a preventive footing, with stricter controls, documentation, and supplier verification requirements. This means there is a new regulatory world for food producers, including regulations for food-borne illness prevention and traceability. Presentation provides a summary of the new regulations, the risks and challenges faced by food producers, and the opportunities to take action through applications of modern control and information technology.
Overview of Japanese Foreign Manufacturers Accreditationjapan-rs
This document discusses the process for foreign manufacturers to obtain accreditation from the Japanese Ministry of Health, Labour and Welfare to export medical devices to Japan. It outlines the requirements, application process, and fees for initial accreditation, changes to an existing accreditation, renewal of accreditation, and notifications of changes. The accreditation process involves submitting application documents to both the Ministry and the Pharmaceutical and Medical Devices Agency, who reviews facilities and processes to ensure compliance with Japanese regulations.
This document provides an overview and summary of Canada's new Safe Food for Canadians Regulation (SFCR) which comes into effect on January 15, 2019. It outlines the key elements of the new regulation including licensing requirements, preventive control measures, traceability rules, and the steps companies need to take to transition. The regulation aims to modernize and consolidate Canada's food safety rules and better protect consumers from foodborne illness.
Process guidelines for foreign companies exporting infant formula to china(f...Rong Liu
After years of dedicating to Chinese dairy and infant formula market, we have summarized the opportunities& challenges for foreign infant formula companies to enter and stay in China market.
After tracking the related regulations, standards, notices, we also provide you a process guideline as well as regulation mapping regarding Chinese dairy industry especially for infant formula.
We are confident that this document can help foreign manufactures, international traders master the whole and clear picture about Chinese infant formula market from regulatory perspective.
Safe Food for Canadians Regulation – Are You Ready?
The Safe Food Canadians Act is a bit of a ‘sleeping’ giant, as the regulations came into effect January 15, 2019. Many food companies both within Canada and outside its borders are still trying to figure out what they need to do in order to comply.
This informative webinar featuring Cameron Prince with The Acheson Group discusses:
- Top 3 pillars of the Safe Food Canadians Regulations and how they compare to FSMA
- What companies should have in place, or work towards quickly, to ensure compliance – relative to licensing, traceability and preventive controls
- The long term impact these regulations will have on food companies, and predictions on enforcement
Learn more at https://safetychain.com
Import and export regulations laws of usaSanjay Yadav
This document discusses FDA regulations regarding the import and export of medical products. It outlines the authorities FDA has to examine imported foods, drugs, and other products. It provides details on import documentation and entry requirements. It also discusses requirements for exporting over-the-counter drugs and unapproved new drugs in accordance with Section 802 of the Federal Food, Drug, and Cosmetic Act.
This document summarizes the drug approval processes in Europe and India. In Europe, there are four approval procedures - centralized, mutual recognition, decentralized, and national. The centralized procedure provides approval across the European Union and is required for certain drug classes. The other procedures allow approval in multiple or individual European countries. The process involves a clinical trial application, marketing authorization application, assessment reports, and regulatory agency reviews. In India, companies must apply to the Drugs Controller General of India and conduct clinical trials according to Schedule Y guidelines to obtain approval. The process is generally longer in India, taking 12-18 months versus approximately 12 months in Europe. Both regions have stringent requirements for new drug approval and regulate the pharmaceutical industry to protect public health
The document discusses pesticide registration processes and requirements in India. It covers registration under sections 9(3), 9(3B), and 9(4) of the Insecticides Act 1968 for technical manufacture, import, and formulation of insecticides, herbicides, fungicides, and biopesticides. It also discusses registration for export and requirements for enhancement of product shelf life, alternate packaging, and other permits. Primary Information Services provides assistance with registration, dossier preparation, and maintains databases of registered products, companies, patents, and technical data.
This document discusses India's animal quarantine services and their objectives of preventing the introduction of exotic livestock diseases. It outlines the quarantine stations located across India and their economic importance in saving money through disease prevention and increasing exports. Regulations regarding livestock imports and exports are discussed, highlighting the need for mandatory animal quarantine clearance. Proper technical export certification is emphasized as important for increasing trade and meeting international standards.
This document outlines the Self-Monitoring and Reporting Tools by Industry Rules established in 2001 in Pakistan. It classifies industries into categories A, B, and C for reporting frequencies on liquid effluents and gaseous emissions. It also defines key terms, establishes responsibilities for industrial units to submit monitoring reports, outlines report requirements, and lists priority industries in each classification. The rules aim to support enforcement of environmental standards and develop an industry pollution database.
The document provides information on chemical safety, including what chemical substances are, the forms chemicals can take, how chemicals can be hazardous to health, assessing risks from chemical exposure, effects chemicals can have on the body, how chemicals enter the body, and control measures for chemicals including identifying hazards, assessing exposure and risk, implementing engineering and administrative controls, providing training, safely storing and handling chemicals, and using personal protective equipment.
What are new chemical substance regulations in China? And what are toxic chemical substance regulations in China? How to compliant with these regulations? What inventories can be referred? How enterprises to determine their obligations? Answers can be found in CIRS free webinar for chemical regulations & compliance in China.
This webinar will introduce current chemical management regulations in China and how to fulfill enterprises’ obligations under these regulations. Detailed operationwill be summarized here for GHS and regulatory specialist and related stake-holders to well-understand and follow up.
1) Several corrosive and hazardous chemicals used in industrial plants are discussed, including sulfuric acid, hydrochloric acid, caustic soda, ammonia, chlorine, and hydrazine.
2) The document provides information on the properties and health effects of these chemicals and stresses the importance of safety precautions like protective equipment, ventilation, and emergency response plans when handling them.
3) First aid measures are outlined for exposure to these chemicals through inhalation, skin contact, and eye contact and include irrigation, oxygen administration, and calling for emergency help.
The document summarizes a meeting of the CEEP Water Committee in Brussels on April 16, 2012. It discusses priority substances under the Water Framework Directive, including their classification, emission controls, environmental quality standards, and monitoring. It provides a history of relevant directives and decisions. It outlines the current activities around implementing quality standards by 2021 and revising the list of priority substances. Key points of discussion included potential conflicts between drinking water and waste water services, controlling emissions from various sources, and dealing with ubiquitous and unclassified but hazardous pollutants.
Occurrences of priority substances in selected catchmentsreganf
This document summarizes a study that monitored priority pollutant levels in wastewater treatment plant effluents from various catchments. PAH levels were generally low but detectable in all sites sampled, with levels of naphthalene, anthracene and fluoranthene typically below 1 μg/L. Rainfall data from monitoring stations is also presented.
Moving stories lesson 8 - Population PyramidsMr Hunt
The document discusses using population pyramids to predict population change. It provides population data for the UK in 2010 and 2050 broken down by age and gender. Population pyramids visually depict this data using bars to show male and female populations in each age group. Comparing pyramids from different times allows predicting how a population will change in the future. The homework is to create a 3D population pyramid for the UK in 2050 using materials like Lego bricks or jelly babies and compare it to the 2010 pyramid.
Monazite is a reddish-brown phosphate mineral that is an important ore of rare earth elements such as lanthanum, cerium, and thorium. It commonly occurs as small isolated crystals and has a hardness of 5.0-5.5. Historically, monazite sand from Brazil and India was the primary source of thorium and lanthanides until the 1960s. Monazite deposits can be mined and the monazite extracted using gravity, magnetic, and electrostatic separation due to its high density.
The Vitalife wire rope lubricant was originally developed in the late 1800s to protect the Brooklyn Bridge. It has since been improved upon by American Oil (later Crosby Group) to penetrate wire ropes and protect them from the inside. Vitalife 400 lubricant is effective at reducing friction, wear, corrosion and temperature within wire ropes through its ability to penetrate to the core and form a protective film. Regular application of Vitalife extends the life of wire ropes and reduces costs associated with replacement and downtime.
Fabric softener (also called fabric conditioner) is used to prevent static cling and make fabric softer i.e. Softening agents are applied to textiles to improve their hand, drape, cutting and sewing qualities.Fabric softeners work by coating the surface of the cloth fibers with a thin layer of chemicals; these chemicals have lubricant properties and are electrically conductive, thus making the fibers feel smoother and preventing buildup of static electricity
Prof Graham Mills - The Fate of Pharmaceutical Residues in the Aquatic Enviro...onthewight
Professor Graham Mills presented his talk "The Fate of Pharmaceutical Residues in the Aquatic Environment"
A full background of what contaminates water, from Pharmacology and Agriculture. People passing medicines they have taken or disposing of them by throwing them down the toilet are causing major changes to fish and other water dwelling creatures.
- October 2014 - Cafe Scientifique Isle of Wight
Water pollution occurs when harmful substances affect the quality of water and threaten living organisms. It is a major global issue, contributing to over 14,000 daily deaths. Pollution can come from both human and natural sources. Key pollutants include nutrients from fertilizers and sewage that cause eutrophication and hypoxia, reducing oxygen levels. Various industries, agriculture, urbanization, and marine activities also pollute waterways. Water quality is measured quantitatively using tests for factors like dissolved oxygen, E. coli levels, turbidity, biochemical oxygen demand, and more to assess safety and treat pollution issues.
This document provides an overview and introduction to a training on the nature of chemical hazards and the implications of applying the Globally Harmonized System (GHS) to industry. The goals of the training are to introduce the revised Hazard Communication Standard aligned with GHS, and provide basic awareness of chemicals. Key topics covered include rights and responsibilities under occupational safety laws, the history and development of the GHS, changes to labeling and safety data sheets, and a job hazard analysis approach to controlling chemical hazards.
Water pollution occurs when contaminants are released into water sources, degrading water quality for other uses. There are two main types of water pollution: surface water pollution which impacts oceans, rivers and lakes, and groundwater pollution which impacts underground sources. Water pollution can be caused by sewage, industrial waste, marine dumping, and other sources, and has negative effects on the environment, humans, and animals, including toxic water, diseases, and animal deaths. Individual actions like conserving water, proper fertilizer use, and cleanups can help reduce water pollution.
Earth Resources
Reserves and resources
Nonrenewable Mineral Resources
What are industrial minerals?
Why are industrial minerals so important?
Geology of Industrial Minerals Deposits
Classification of industrial minerals
General characteristics of Non-metallic Deposits
Factors important in evaluating an industrial minerals deposit
Selected industrial rocks and minerals
ABRASIVES MINERALS
OLIVINE
GYPSUM
CLAY MINERALS
FLUORITE
PERLITE
BUILDING STONES and Rip-rap
CALCIUM CARBONATE DEPOSITS
SULFUR ORE DEPOSITS
CHERT DEPOSITS
PHOSPHATE ORE DEPOSITS
EVAPORITE DEPOSITS
SELECTED SOME NON-METALLIC METAMORPHIC DEPOSITS
Asbestos Deposits
Graphite Deposits
Talc, Soapstone, and Pyrophyllite
Selected Some Ornamental Metamorphic Stones
Marble
Quartzite
Serpentinite
This document summarizes China's organic certification system. It outlines the key national standards, certification bodies, and import/export rules. The national standard GB/T 19630 covers production, processing, labeling, and management systems. Certification is provided by approved bodies and requires an annual inspection. Imports must be registered with AQSIQ and are subject to inspection and tariffs. Products must be labeled with the certification body code, year, and random number.
Enhancing Chemical Management Within the Framework of Existing TSCA Regulations3ECompany
This presentation provides a brief history of TSCA, as well as an overview of its scope and sections. It also reviews current activity surrounding TSCA reform and modernization and the potential impact that any reform will have on business.
Enhancing Chemical Management Within the Framework of Existing TSCA Regulations3ECompany
This presentation provides an overview of TSCA as it is currently configured and also reviews plans to reform the bills and possible implications on businesses.
Enhancing Chemical Management Within the Framework of Existing TSCA Regulations3ECompany
This presentation provides an overview of TSCA as it is currently configured and also reviews plans to reform the bills and possible implications on businesses.
clinical trial Management with ethics committeeSrinivasanBB
The document discusses key aspects of clinical trial management including experimental units, treatment and evaluation, approaches to clinical trials, the roles of various organizations, and essential documents. It provides definitions for experimental units and outlines how treatments and evaluations are conducted in clinical trials. It describes the trial approach process including principal investigators, feasibility questionnaires, ethics committee approval, and registration. It also outlines the roles of site management organizations, ethics committees in reviewing protocols and risks/benefits, and regulatory requirements in India including the Drug and Cosmetic Act, regulatory bodies, and the application process. Finally, it discusses important documents for conducting and reporting clinical trials.
US Toxic Substances Control Act (TSCA) ReformCovance
The Toxic Substances Control Act (TSCA) Public Law 94-469, was first signed into Law on October 11, 1976 due to the use of a large number of chemicals in the United States (US) and exposure to human health or the environment. This act was recently updated under 'The Frank R. Lautenberg Chemical Safety for the 21st Century Act', Public Law 114-182, and was signed into Law on June 22, 2016 by US President Obama. The scope of the reform does not include; pesticides, tobacco, nuclear materials, food, drugs or cosmetics. TSCA allows the Environmental Protection Agency (EPA) to assess chemical risks to human health and the environment and to take action to control these risks. In summary, TSCA authorizes the EPA to keep an 'inventory' of all existing chemicals. Currently the inventory comprises approximately 83,000 chemicals that are being manufactured or imported into the US. Chemicals on the inventory can be manufactured or imported into the US, chemicals that are not on the inventory cannot be manufactured or imported into the US.
The Central Drugs Standard Control Organization (CDSCO) regulates drugs, cosmetics, and medical devices in India. It oversees drug approval processes including clinical trials, approves new drugs and ensures quality standards. CDSCO has six regional offices and regulates a large and growing pharmaceutical industry. The new Medical Devices Rules of 2016 classify devices into four risk-based categories from low to high risk. CDSCO also oversees recalls of drugs that are found to be deficient in quality, efficacy, or safety.
This document provides an overview of pharmaceutical regulations for drug approval in the US, EU, and India. It discusses the drug approval processes and requirements in each region, including the types of applications submitted (e.g. ANDA, NDA), necessary documentation, evaluation timelines, and guidelines followed (e.g. ICH). It also compares some key parameters of the regulatory frameworks like bioequivalence study designs, criteria, and pharmacokinetic measures assessed between the different jurisdictions.
The document discusses the pharmaceutical industry development process in India. It outlines the legal requirements and licenses needed to manufacture or import APIs and drugs. Companies must seek approval from the DCGI and adhere to CDSCO guidelines. The application process requires submitting chemical, pharmaceutical, pre-clinical and clinical data. Various forms are used for obtaining manufacturing, import, and sales licenses from the CDSCO. The CDSCO-SUGAM project aims to streamline approval processes.
(15 mph104) cdsco & fda guidelinesDishant shah
This document provides an overview of CDSCO and FDA guidelines for drug approval. It begins with an introduction to CDSCO as India's national regulatory body equivalent to agencies like the EMA and FDA. It describes CDSCO's organization, functions in approving drugs and devices, and guidelines. It then explains the Common Technical Document format used for drug submissions and its modules. Guidelines for areas like cosmetics, clinical trials, and bioavailability and bioequivalence are summarized. The document concludes with references to CDSCO and FDA websites for further information.
This document provides an overview of the key provisions of REACH, the new European Union chemical regulatory scheme. REACH will require chemical manufacturers and importers to register substances and provide safety data. It establishes provisions for evaluating chemicals of concern, restricting or authorizing high-risk substances, and communicating safety information down the supply chain. The European Chemicals Agency will administer REACH and coordinate with EU member states on enforcement.
The document discusses Thailand's drug registration and control system. It provides details on:
1) The organizational structure of Thailand's Food and Drug Administration (FDA) and its drug control divisions that are responsible for pre-and post-marketing activities like inspections, monitoring, and surveillance.
2) Thailand's drug registration process which requires licensees to obtain licenses before selling, manufacturing, or importing drugs. The registration ensures safety, efficacy and quality.
3) Different categories of drugs and their registration processes, timelines, and requirements. Priority review is given to drugs addressing public health issues.
4) Ongoing efforts to strengthen regulatory capacity, encourage compliance, and facilitate access through various initiatives and
Presentation - Phase 1 & BA/BE Process FlowInfo Kinetics
This document provides information about clinical research services offered by Info Kinetics Sdn Bhd /Clinical Research Centre. It summarizes their facilities including a 36-bed clinical pharmacology unit, bioanalytical laboratory, and data management capabilities. It also outlines their quality accreditations and experience conducting various types of clinical studies including phase 1 and bioavailability/bioequivalence studies. Timelines for pre-study activities, study conduct, and reporting are presented. Regulatory application processes are also described.
a concise yet very informative presentation, on drug approval process and clinical trial regulations in India, prepared for clinical research students
Please refer notes for abbreviations and additional information
Regulatory aspect of pharamacutical packgingvineet gupta
There is no doubt that the regulatory climate is getting more restrictive for pharmaceutical products and it is likely that packaging for pharmaceuticals will have more and more constraints placed upon it.
The document discusses chemical safety regulation in the United States, including changes made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) of 2016. Key points of the LCSA include giving EPA broader authority to review existing and new chemicals, establishing a uniform national approach through state preemption, overhauling confidential business information claims, increasing civil and criminal penalties, and mandating mercury reporting. The timeline for compliance under the LCSA requires EPA to take initial actions like prioritizing chemicals for risk evaluation within six months and complete 10 chemical risk evaluations. It also outlines how companies should prepare for the new requirements. The LCSA is compared briefly to the European Union's RE
Taiwan medical device registration and approval chart - EMERGOEMERGO
Taiwan regulates medical devices through the Pharmaceutical Affairs Act and Regulations for Governing the Management of Medical Devices. The process involves classifying the device, appointing a Taiwan agent, preparing quality system documentation for submission, and obtaining approval. Device classification and complexity of approval requirements vary, with Class I generally having the simplest process taking 1-2 months, Class II taking 10-12 months, and Class III taking 10-12 months and requiring a committee review.
Similar to Taiwan chemical substance registration analysis and supervision measures update (20)
WRI’s brand new “Food Service Playbook for Promoting Sustainable Food Choices” gives food service operators the very latest strategies for creating dining environments that empower consumers to choose sustainable, plant-rich dishes. This research builds off our first guide for food service, now with industry experience and insights from nearly 350 academic trials.
ENVIRONMENT~ Renewable Energy Sources and their future prospects.tiwarimanvi3129
This presentation is for us to know that how our Environment need Attention for protection of our natural resources which are depleted day by day that's why we need to take time and shift our attention to renewable energy sources instead of non-renewable sources which are better and Eco-friendly for our environment. these renewable energy sources are so helpful for our planet and for every living organism which depends on environment.
different Modes of Insect Plant InteractionArchita Das
different modes of interaction between insects and plants including mutualism, commensalism, antagonism, Pairwise and diffuse coevolution, Plant defenses, how coevolution started
Optimizing Post Remediation Groundwater Performance with Enhanced Microbiolog...Joshua Orris
Results of geophysics and pneumatic injection pilot tests during 2003 – 2007 yielded significant positive results for injection delivery design and contaminant mass treatment, resulting in permanent shut-down of an existing groundwater Pump & Treat system.
Accessible source areas were subsequently removed (2011) by soil excavation and treated with the placement of Emulsified Vegetable Oil EVO and zero-valent iron ZVI to accelerate treatment of impacted groundwater in overburden and weathered fractured bedrock. Post pilot test and post remediation groundwater monitoring has included analyses of CVOCs, organic fatty acids, dissolved gases and QuantArray® -Chlor to quantify key microorganisms (e.g., Dehalococcoides, Dehalobacter, etc.) and functional genes (e.g., vinyl chloride reductase, methane monooxygenase, etc.) to assess potential for reductive dechlorination and aerobic cometabolism of CVOCs.
In 2022, the first commercial application of MetaArray™ was performed at the site. MetaArray™ utilizes statistical analysis, such as principal component analysis and multivariate analysis to provide evidence that reductive dechlorination is active or even that it is slowing. This creates actionable data allowing users to save money by making important site management decisions earlier.
The results of the MetaArray™ analysis’ support vector machine (SVM) identified groundwater monitoring wells with a 80% confidence that were characterized as either Limited for Reductive Decholorination or had a High Reductive Reduction Dechlorination potential. The results of MetaArray™ will be used to further optimize the site’s post remediation monitoring program for monitored natural attenuation.
Evolving Lifecycles with High Resolution Site Characterization (HRSC) and 3-D...Joshua Orris
The incorporation of a 3DCSM and completion of HRSC provided a tool for enhanced, data-driven, decisions to support a change in remediation closure strategies. Currently, an approved pilot study has been obtained to shut-down the remediation systems (ISCO, P&T) and conduct a hydraulic study under non-pumping conditions. A separate micro-biological bench scale treatability study was competed that yielded positive results for an emerging innovative technology. As a result, a field pilot study has commenced with results expected in nine-twelve months. With the results of the hydraulic study, field pilot studies and an updated risk assessment leading site monitoring optimization cost lifecycle savings upwards of $15MM towards an alternatively evolved best available technology remediation closure strategy.
Top 8 Strategies for Effective Sustainable Waste Management.pdfJhon Wick
Discover top strategies for effective sustainable waste management, including product removal and product destruction. Learn how to reduce, reuse, recycle, compost, implement waste segregation, and explore innovative technologies for a greener future.
Improving the viability of probiotics by encapsulation methods for developmen...Open Access Research Paper
The popularity of functional foods among scientists and common people has been increasing day by day. Awareness and modernization make the consumer think better regarding food and nutrition. Now a day’s individual knows very well about the relation between food consumption and disease prevalence. Humans have a diversity of microbes in the gut that together form the gut microflora. Probiotics are the health-promoting live microbial cells improve host health through gut and brain connection and fighting against harmful bacteria. Bifidobacterium and Lactobacillus are the two bacterial genera which are considered to be probiotic. These good bacteria are facing challenges of viability. There are so many factors such as sensitivity to heat, pH, acidity, osmotic effect, mechanical shear, chemical components, freezing and storage time as well which affects the viability of probiotics in the dairy food matrix as well as in the gut. Multiple efforts have been done in the past and ongoing in present for these beneficial microbial population stability until their destination in the gut. One of a useful technique known as microencapsulation makes the probiotic effective in the diversified conditions and maintain these microbe’s community to the optimum level for achieving targeted benefits. Dairy products are found to be an ideal vehicle for probiotic incorporation. It has been seen that the encapsulated microbial cells show higher viability than the free cells in different processing and storage conditions as well as against bile salts in the gut. They make the food functional when incorporated, without affecting the product sensory characteristics.
Presented by The Global Peatlands Assessment: Mapping, Policy, and Action at GLF Peatlands 2024 - The Global Peatlands Assessment: Mapping, Policy, and Action
Improving the Management of Peatlands and the Capacities of Stakeholders in I...
Taiwan chemical substance registration analysis and supervision measures update
1. CIRS
Your Compliance Expert
Taiwan Chemical Substance Registration Analysis and
Supervision Measures Update
Ethan Zheng
CIRS
ethan.zheng@cirs-group.com
1
2. Taiwan Chemical Control Regulations Introduction
Late Pre-registration for Existing Substance
R&D Application
CBI Protection
Chemical Commodity Importation Pre-Confirmation (CCIP)
Case Study and Take Home Messages
2
3. Taiwan Chemical Control Regulations Introduction
TCSCA OSHA Other Regulations
Taiwan EPA
December 11th , 2013
-Toxic Substance
-New Substance
-Existing Substance
Taiwan MOL
July 3rd , 2013
-Priority Substance
-Prohibited Substance
-New Substance
Other governments
-Food
-Drug
-Agro
-…
3
4. Taiwan Chemical Control Regulations Introduction
Registrant
1. Importer or manufacturer located in Taiwan
2. Third party representative (TPR) located in
Taiwan
3. Companies located outside of Taiwan can
appoint a TPR to work with importer to
submit the registration
* Each Taiwan importer needs to register
Importer A
Importer B
Importer C
Foreign Manufacturer EPA & OSHA
Foreign Countries Taiwan
TPR
4
5. Taiwan Chemical Control Regulations Introduction
Substance
In TCSINot in TCSI
Exempted New Substance Registration
Small Quantity
Registration
Simplified
Registration
Standard
Registration
Assessment and Review
of the submitted dossier
Phase 1 Registration
if >= 0.1 t/y
Designated Substance
based on the
prioritization process
Phase-in Standard
Registration of
designated substance
Approved
Post Registration Management
TCSI: Taiwan Chemical
Substance Inventory
5
6. Taiwan Chemical Control Regulations Introduction
R&D Substance Polymer
PPORD R&D CMR Regular
On-Site
Intermediate
Polymer PLC
STD1 STD1
STD4
STD4
STD1 STD1
Small
Quantity
STD3
STD3 STD2
Simplified Simplified STD2 STD1 Simplified Simplified
Small
Quantity
STD1
Simplified
Small
Quantity
Small
Quantity
Pre-
ApprovalSmall
Quantity
0.1 t
1 t
10 t
100 t
1,000 t
Annual
Tonnage
New Substance Registration
Small Quantity Registration Simplified Registration Standard Registration
6
7. Taiwan Chemical Control Regulations Introduction
New Substance Registration
TCSCA and OSHA are using
one submission window to
collect registration documents
One dossier for both
regulations
One payment for both
regulations
One registration number
for both regulations
Payment Submit Review Issue Management
OSHA
TCSCA
Managed separately
7
8. Finish Phase 1
Standard
Registration
before due time
Taiwan Chemical Control Regulations Introduction
Existing Substance Registration
Pre-Registration Late Pre- Registration Standard Registration
List of substances
requiring phase 1
standard registration
will be published
Pre-Registration of
Existing Substance
2015.09.01 2016.03.31
Implementation of the Act
of Registration of Existing
and New Substance under
TCSCA
2014.12.11 2017.12.31
Late Pre-Registration
8
9. Taiwan Chemical Control Regulations Introduction
Registration Progress
800+
7 6
330
270
New Substance
Small Quantity Simplified
STD PLC
R&D
10,00
0+
150,0
00+
Application Substances
Existing Substance Phase I
Registration
During Dec. 11th , 2014 to March 31st, 2016 9
Unofficial
10. Taiwan Chemical Control Regulations Introduction
Late Pre-Registration for Existing Substance
R&D Application
CBI Protection
Chemical Commodity Importation Pre-Confirmation (CCIP)
Case Study and Take Home Messages
10
11. Late Pre-Registration for Existing Substance
What if you missed the Pre-Registration?
(Ended on 31st March 2016)
What is Pre- Registration?
Phase I Registration = Pre-Registration Under EU REACH
Phase I Registration Conditions
- Existing Substance
- The average annual tonnage of import/manufacture
exceeds 0.1 t/y for the previous three years
-The annual tonnage of one year of the past three years
exceeded 0.1 t/y
- You can still submit the Pre-Registration if you meet the
conditions above.
- Send a paper application to EPA, based on the EPA
review, EPA will open the Pre-Registration again for
applicant
11
Pre-Registration
making up process and
detail published by EPA
on May 10th 2016.
12. Late Pre-Registration for Existing Substance
Late Pre- Registration
Conditions
- Starting from April 1st 2016, manufacturing or
importing existing substance larger than 0.1 t/y
for the first time;
- The amount of existing substance manufactured
or imported smaller than 0.1 t/y for the previous
years, but the amount exceeds 0.1 t/y after April
1st 2016.
Deadline for Late Pre-Registration
- Application should be submitted within 90 days
after the first manufacture or import takes place
after April 1st 2016
12
* Annual tonnage counting
starts from Jan 1st 2016
13. Late Pre-Registration for Existing Substance
Late Pre- Registration Procedures
Applicant (manufacturer/importer)
First manufacture/import > 0.1 t/y since April 1st
2016. Application submitted within 90 days
Submit related registration and supporting documents and POA
Authority review of the supporting documents
Make payment
Authority review of dossier
Phase I registration code issued
Review passed
Review not passed
Resubmit
supporting
document
Review passed
Review not passed
Resubmit
dossier and
POA
13
14. Late Pre-Registration for Existing Substance
Late Pre- Registration Documents
Supporting
Documents
Registration
Documents
Product
Information
-Declaration of Import
-Trade certificate
-Contract
-Shipping approval
-Applicant information
-Substance information
-Substance manufacture
and usage information
-Power of Attorney
-SDS
-or product content sheet
14
15. Taiwan Chemical Control Regulations Introduction
Late Pre-Registration for Existing Substance
R&D Application
CBI Protection
Chemical Commodity Importation Pre-Confirmation (CCIP)
Case Study and Take Home Messages
15
16. R&D Application
1. Scientific Research purpose
2. PPORD: Product and Process Orientated Research and Development
On March 10th 2016, Taiwan
EPA published the new
version, version 2 of the
R&D application guideline
Changes:
Enterprise is allowed to apply
for scientific research purpose
if manufactured or imported
amount is less than 1 t/y
16
17. R&D Application
R&D Application Procedures
PPORD Scientific Research
> 1 ton per year
Submit registration
according to tonnage
EnterprisesResearch Institute
R&D Testing Appointed
EPA Review
Registration Exempted
NoYes
R&D Usage ApplicationNo
application
needed
Approved
17
18. R&D Application
A Case Study
A Taiwan importer wants to import a new substance and sell the substance to its
downstream user for the R&D purpose, is the Taiwan importer able to apply for the
R&D exemption?
-If the importer is appointed by a scientific research institute to import the new
substance, and the amount of the new substance is < 1t/y, it is able to apply for the
R&D exemption for the importer with sufficient related documents.
-If the importer only imports the new substance to sell to the downstream users, the
new substance has to be registered normally.
18
19. Taiwan Chemical Control Regulations Introduction
Late Pre-Registration for Existing Substance
R&D Application
CBI Protection
Chemical Commodity Importation Pre-Confirmation (CCIP)
Case Study and Take Home Messages
19
20. CBI Protection
Information can be kept confidential
1. Applicant information
2. Substance identity information
3. Substance manufacture or import information
4. Substance usage information
CBI Protection Duration
1. Standard Registration: 5 years
2. Simplified/Small Quantity Registration: 2 years
* Application for CBI Protection extension should be submitted 3
months before expiration date.
* 15 years is the longest time for CBI protection
20
21. CBI Protection
Information must be disclosed
1. Substance hazard classification information
2. Substance physical and chemical property information
3. Substance toxicological and eco-toxicological information
4. Substance hazard assessment information
5. Substance exposure assessment information
* Information regards to human and environmental safety and
health must be disclosed
* Details about how the information be disclosed is still under
discussion by Taiwan authorities, and will be released in the
future
21
22. Taiwan Chemical Control Regulations Introduction
Late Pre-Registration for Existing Substance
R&D Application
CBI Protection
Chemical Commodity Importation Pre-Confirmation (CCIP)
Case Study and Take Home Messages
22
23. Chemical Commodity Importation Pre-Confirmation (CCIP)
Taiwan authorities want to make sure that all the
imported commodities have complied with the
related requirement before entering the customs
Chemical Commodity Importation Pre-Confirmation
(CCIP) Platform
Helps enterprises get familiar with the importation
processes
More smooth and efficient post inspections
23
24. Chemical Commodity Importation Pre-Confirmation (CCIP)
Importation management processes
Enterprises self confirmation CCIP confirmation Authority post inspection
Substance regulated by
other laws?
Substance registered
and registration code
received?
Finish related substance
registration
Go to CCIP website
Chemreg-border.epa.gov.tw
Step 1 read agreement
Step 2 fill in information
1. Applicant information
2. Product information
3. Substance information
Finish CCIP
EPA receives monthly
import record with
C.C.C.code
Carry out inspection
according to company
names/C.C.C.code
Check CCIP information
and substance
compliance
Yes
End No
No Yes
24
25. Chemical Commodity Importation Pre-Confirmation (CCIP)
CCIP process details Go to CCIP website
Step 1 read agreement
Confirm new substance
information in the
product
Fill in applicant information
Fill in product information
Confirm existing
substance information
in the product
Confirm other
substance information
in the product
1. Registration code
2. CAS number
3. Components
4. …
1. Registration code
2. CAS number
3. Components
4. …
1. CAS number
2. Components
3. Exemption reason
4. …
Finish CCIP 25
26. Chemical Commodity Importation Pre-Confirmation (CCIP)
Who can use the CCIP platform to do the pre-confirmation?
CCIP user can be:
1. Taiwan importer
2. Third party representative
3. Foreign company
4. Other
* The “registrant name” in the submitted CCIP information should be the
same as the “taxpayer” on the customs declaration form. Different names
may cause false post inspection.
26
30. Taiwan Chemical Control Regulations Introduction
Late Pre-Registration for Existing Substance
R&D Application
CBI Protection
Chemical Commodity Importation Pre-Confirmation (CCIP)
Case Study and Take Home Messages
30
31. Case Study and Take Home Messages
Company A wants to import a batch of product into Taiwan now. The substance
contained in this product is existing substance with the amount of 120 kg. How does
company A comply with the chemical regulation in Taiwan?
Case Study 1
Late Pre-Registration condition:
For the first time importation/manufacturing after April 1st 2016, with the
amount >0.1 ton per year, Late Pre-Registration is applicable.
Company A should do the Late Pre-Registration and submit the related
documents (product information, substance information, POA, supporting
document, etc.)
After finishing the Late Pre-Registration, company A will also need to finish
the CCIP.
31
32. Case Study and Take Home Messages
Company B wants to import a product that contains new substance into Taiwan. The
annual amount of the new substance is 5 ton per year. How does company B comply
with the chemical regulations in Taiwan?
Case Study 2
For new substance:
All the new substance should be registered before being imported or
manufactured.
Based on the information of annual amount of 5 ton per year. The substance
is subject to both TCSCA and OSHA standard new substance registration level
1. Related documents should be prepared by company B.
Documents includes: testing report (physicochemical data, toxicological data
and eco-toxicological data) and application form of standard registration.
* Only two re-submission chances available 32
33. Case Study and Take Home Messages
Company C has already completed the new substance registration of their product,
and the substance has been added into the TCSI. Does company C need to do the
Phase 1 Registration for their substance?
Case Study 3
If company C has already finished the new substance registration, and the
substance has been added into TCSI, then there is no need to do the existing
substance registration.
33
34. Case Study and Take Home Messages
What if I do not do the CCIP?
Case Study 4
Can still get through the customs
Currently, the CCIP is not mandatory, products can still get through without
the CCIP.
Priority post inspection
Post inspection will be prioritized for the products without CCIP
Punishment will be made for illegal behaviors
If importers are found with illegal behaviors (not compliant to the chemical
regulations in Taiwan), related punishment will be made
34
35. Case Study and Take Home Messages
Do we need to do CCIP each time we import our product?
Case Study 5
If the imported product are the exactly same product as the one imported
before (same chemical composition, same substances), CCIP is only required
at the first importation
If the chemical composition changes, or other substances are added,
companies need to re-do the CCIP since the product will be considered as a
new product.
35
36. Useful Links
1. TCSI search engine:
https://csnn.osha.gov.tw/content/home/Substance
_Home.aspx
2. Search Engine for Chemical Inventory in China:
http://cciss.cirs-group.com/
3. Regulatory Related Materials Download:
http://freedoc.cirs-group.com/en/
4. Regulatory News Updates:
http://www.cirs-reach.com
Find us on LinkedIn: https://www.linkedin.com/company/chemical-
inspection-and-regulation-service-limited?trk=biz-companies-cym
36
37. Our Services
Taiwan
- (Late) Pre-registration
- Existing substance registration
- New substance registration
- CCIP application
- Taiwan GHS
- Regulatory training
China
- New substance notification
- Hazardous substance registration
- Environmental administration
registration
- China GHS
- Regulation training
Korea
- Existing substance registration
- New substance registration
- Annual reporting
- Korean GHS
- Regulatory training
Global GHS
- EU CLP
- China, Japan, Korea, Taiwan
- US, Canada
- Malaysia, Thailand, Indonesia
- Others like Turkey, Brazil, Mexico,
Russia, Australia, New Zealand,
etc.
38. Next Webinar: China Chemical Regulations Overview
• Main Contents
New Substance Notification
Hazardous Substance Registration
Environmental Administration Registration of Hazardous
Substance
Licence System
GHS, SDS and Label
Language Date Time Speaker
English
(EU Area)
June 7th 2016 16:30 – 17:30 pm
(Beijing Time)
Ms. Grace Chen
English
(US Area)
June 7th 2016 23:00 – 00:00 pm
(Beijing Time)
Mr. Ethan Zheng
Please visit www.cirs-reach.com for registration information.
http://www.cirs-reach.com/news-and-articles/chemical-regulations-and-compliance-in-china.html
CIRS
Your Compliance Expert
39. Thank You!
CIRS will be ready to help!
Ethan Zheng
My email: ethan.zheng@cirs-group.com
39