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Section 21 of the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) allows for the introduction of new chemicals into Australia provided the chemicals meet certain requirements stipulated in subsections 21(4) and 21(6) of the Act.
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The nomination period for the Russian Inventory is formally closed now. During this nomination period, the GPC group has helped 20+ companies to nominate 350+ substances. The Russian inventory, which is expected to be publishe
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On April 29, 2020, China's Ministry of Ecology and Environment (MEE) published the Measures on Environmental Management Registration of New Chemical Substances (MEE Order 12). The amendment will come into force on January 1, 2021 and replace th
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With Brexit being implemented, The UK has formally left the EU on 31st January 2020 with a withdrawal deal and has now gone into an 11-month transition period which is most likely to end on 31st December 2020. The negotiations between the UK and the
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Turkey REACH, which had come into force on June 23rd, 2017, had begun its pre-Registration phase starting from the 23rd of December 2017 and the closing date as 31st of December 2020. From 1st Jan 2021 only those companies who have “Pre-Regist
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What is CMSR? India released the fourth draft of the Chemical (Management and Safety) Rules (CMSR) on March 16, 2020. The CMSR will regulate Substances, Substances in Mixture, Substance in Articles and Intermediates that are manufactured, imported
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On March 11, 2019, Taiwan’s EPA published the amended regulation on New and Existing Chemical Substances, specifying Standard Registration for 106 existing chemical substances. From 1 January 2020, manufacturers or importers who manufacture or impo
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The Ministry of Industry in Thailand published its new regulation B.E. 2558 on the notification of the production and import of hazardous substances in Government gazette regarding production and import of hazardous substances which come into force o
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Switzerland has updated the list of substances notified or registered in the country, with 385 additions in June. New substances manufactured or imported into the country, in a volume greater than one tonne per year, must be notified to the Swiss che
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According to Taiwan’s Toxic and Concerned Chemical Substance Control Act (TCCSCA), new and existing substances must be registered in Taiwan. The first batch of 106 PECs was published on 11 March 2019. Taiwan’s EPA published the draft of Guidance
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The first Registration deadline under K-REACH is by 31 December 2021, which applies to those who manufacture and import existing chemical substances exceeding 1,000 tons per year, or carcinogenic, mutagenic, or reproductive toxins (CMR) at more than
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Brexit being implemented from 31st January 2020, the UK has formally left the EU with a withdrawal deal and it is currently in transition period up to 31st Dec. 2020. The UK and the EU have ruled out the possibility of extending the transition period
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To reduce negative impacts from COVID-19 pandemic, the Ministry of Environment (MoE) plans to skip some documents required for new chemical substance Registration from 1 January 2020 to 31 December 2021. This applies to new substances manufactured an
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A South Korea’s industry support group published a list of 332 substances that require prompt CICO establishment. These substances are the cases where pre-registrants of a concerning chemical have not selected a Lead Registrant (LR) or no activitie
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My understanding from speaking with the Toxic and Chemical Substance Bureau is that the EPA’s plan to delay the Pecs deadline is partly due to the pandemic. But it is also because Taiwanese enterprises are still not familiar with standard registrat
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Previously, testing labs were all required to adhere to OECD guidelines or be ISO certified, but the guidance does not mention if universities and colleges need to follow those standards," said Chia-Sui Hsu from Global Product Compliance (GPC). See m
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In case of import, UFI can be used in the communication with a non-EU supplier. The following way can be considered to work around possible communication problems (e.g. if the non EU supplier intends to protect the confidentiality of the mixture info
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In June, Taiwan’s EPA published official guidance on how to prepare a standard Registration dossier for the first list of 106 Priority Existing Substances (PECs). Companies are required to submit nine information items to the authorities. Because o
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While there are less than 160 days left for the first phase for Turkey’s REACH regulation to conclude, more than 18,000 substances were pre-registered already by the first half of 2020, reportedly. Pre-Registration (or more accurately pre-SIEF
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According to Taiwan’s Toxic and Concerned Chemical Substance Control Act (TCCSCA), new and existing substances must be registered in Taiwan. The first batch of 106 PECs was published
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A South Korean industry support group published a list of 332 substances that require prompt CICO (Chemical Substance Information Communicative Organization) establishment. These s
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While there are less than 160 days left for the first phase for Turkey’s REACH regulation to conclude, more than 18,000 substances were pre-registered already by the first half
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Ministry of Agriculture and Forestry has announced a new draft regulation regarding pesticides on food of plant or animal origin, adapted from European regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on m
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Turkey’s REACH-like regulation KKDIK, adapted from EU REACH as a European adaptation policy, is yet in the first phase – pre-Registration phase as known. There have been queries from many organizations regarding the chance of having a late-pre-re
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China opened a public consultation on the new Guidance on Environmental Management Registration of New Chemical Substances. The draft guideline provides implementation design for the MEE ORDER 12 with regards to the scope of Registration, data requir
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The final draft of the Indian Chemicals Management and Safety Rules (CMSR – India REACH) is out now! Next Step: After final optimization, Indian CMSR will go for the World Trade Organization (WTO) Notification (60 Days) The Indian CMSR would
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Unlike EU-REACH, K-REACH requires manufacturers and importers to register polymers. Based on definitions and scope of polymer Registration specified in K-REACH, they shall either register manufactured and imported polymers or apply for an exemption c
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Taiwan’s Environmental Protection Administration (EPA) has amended its chemical control law ‘Toxic Chemical Substances Control Act (TCSCA)’ and renamed it 'Toxic Chemicals and Concerned Substances Control Act (TCCSCA).' This regulatio
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According to the latest update from the Ministry of Environment and Urbanization of Turkish Republic, pre-SIEF notification module in KKS (Chemical Registration System) will be kept active even after the pre-Registration deadline, 31st December 2020.
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The Ministry of Environment and Urbanization of the Turkish Republic has published the draft of the price list for Registration fees. It is known from the regulation from before that Registration, updating Registration, request on confidentiality,
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The Government of the Russian Federation has identified responsible institutions for implementing the Eurasian Technical Regulation 041 (TR 041), an official decree published on 16 September 2020. The Ministry of Industry and Trade of Ru
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The Thai Ministry of Public Health launched a public survey to collect information on the Food Contact Materials (FCMs) currently on the market. According to Chemical Watch, the different types of materials survey covers are glass, ceramics, metal �
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With Brexit being implemented from 31st January 2020, the UK has formally left the EU with a withdrawal deal and it is currently into an 11-month transition period. The UK is no longer a member state of the EU and until the end of the transition p
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Notification to the Vietnam chemical inventory is reopened the notification to the inventory may be done before 15th April 2021. A longer time duration of about six months is provided so that all stakeholders could gather relevant information and nom
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Vietnam has reopened the nomination of chemicals for inclusion in its draft national inventory until 15 April next year.  In the first round of nominations, the Vietnamese Centre for Emergency Response to Chemicals (VCERC) accepted submission
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With the deadline for implementation of MEE ORDER 12 is fast approaching, on October 27th, 2020, the Chinese Ministry of Ecology and Environment (MEE) published the Notice on Transitional Arrangements for Environmental Management Registration of New
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With Brexit being implemented from 31st January 2020, the UK has formally left the EU with a withdrawal deal and it is currently into an 11-month transition period. The UK is no longer a member state of the EU and until the end of the transition pe
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Owing our experience and growth to the requests and guidance of our client base, we, Global Product Compliance have established our branch in Turkey on February 2020, as already known. Since then, we have been working hard to help our loyal client
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According to the amended Toxic and Concerned Chemical Substance Control Act, Taiwan’s EPA has to regularly review its fee scheme. According to the proposed revision on “the Toxic Chemical Substances Handling Application and Chemical Substa
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On November 2, the Ministry of Environment (MoE) in South Korea announced the revised K-REACH rules. The reason is to ensure effective implementation of the K-REACH regulation. Four main revisions were proposed: 1. Registrants can have an exte
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On November 3rd 2020, Australian government announced that introducers (manufacturers or importers) of cosmetic toothpaste or oral hygiene products need to register their business only if their products meet the requirement of Therapeutic Goods (
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On November 11.2020, the chemical Registration IT System of KKDIK (Turkey REACH) was updated. The updated system is more user-friendly and slightly different than the previous one in terms of usage and information requirements. Previously, reg
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To ensure the implementation of Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No.12), MEE released the final version of Guidance on the application of MEE Order No.12 which is expected to come into f
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  The UK will exit the transition period on December 31, 2020.  From 2021, the EU REACH Regulation will be brought into UK law under the European Union (Withdrawal) Act 2018 and this chemical regulation is also known as UK REACH. REACH, and
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With the approaching of the implementation of MEE Order No.12, MEE published a transition measure – Notice on Transitional Arrangements for Environmental Management Registration of New Chemical Substance – on 27th October 2020. This measure a
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Are you introducing soaps into Australian territory for commercial purposes to make a profit? Then you must register under AICIS. The Registration duty applies only if soaps manufactured in Australia involving a chemical reaction (such as s
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The EPA showed its intention to grant the extension of the deadline for Standard Registration of 106 PECs as chemical manufacturing and import associations in Taiwan raised their concerns over the preparation for dossiers in public seminars in Oc
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The amended SEA Regulation, the “Bylaw on Classification, Labeling and Packaging of Substances and Mixtures” (the CLP regulation) in Turkey, was published on 10 December 2020 in the Official Gazette No.31330. This amendment harmoniz
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  According to a statement released by ECHA on January 11, 80% of all EU-REACH Registrations held in the UK have been or are in the process of being transferred back into the EU. The remaining 20%, for which the transfer process had not be
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South Korea added three substances in the 741 existing biocidal substance list therefore, the total number of biocidal chemicals in the existing list becomes 744 entries. It includes: Chlorine dioxide generated from sodium chlorite by oxida
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Following the end of the Brexit transition period on 1st January 2021, the UK REACH Regulation is now in force. UK REACH, which has been described as mirroring its EU counterpart, applies instead of EU REACH in respect of Great Britain (England,
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The Registration phase for Turkey REACH has kick-started by 1st of January 2021 as the deadline for pre-Registration was passed. During the pre-Registration phase, GPC has pre-registered around 3200 substances to secure business of our clients fo
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Russian Ministry of Industry and Trade (Minpromtorg) has now published the finalized version of the inventory of chemical substances. The finalized version contains +80.000 substances notified to the Minpromtorg from December 2019 to August 2020.
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    When Israel joined the OECD in 2010, the country planned to establish a national mechanism for registering chemicals. There are various regulations in Israel that regulate the practice of chemicals, aspects of import, production, occu
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Chemical Regulations Updates in 2020 K-REACH K-REACH requires Registration for all existing chemicals manufactured and imported to South Korea in quantities exceeding 1 ton per year. Joint Registration is mandatory under K-REACH unless the
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In late January, after a month of the implementation of the MEE Order.12, China’s Solid Chemical Waste Management Center (SCC) published the first notification of the first activity and annual report. This notification provides detailed the re
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Grandfathering is a transitional arrangement under UK REACH that allows GB-based manufacturers and importers of a substance registered under EU REACH to continue to import or manufacture that substance in Great Britain past the end of th
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The Ministry of Environment and Urbanization in Turkey published an announcement about new functions added to the chemical Registration system on February 15, 2021.  With the new change, the voting function will be integrated into the KKS so
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The Brazilian Health Regulatory Agency (ANVISA) has been submitting several proposals of the country’s agrochemical standards to the WTO in February. All of the modification proposals are open to public consultation until April 4th, 2021. Th
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Northern Island (NI) is part of EU regulatory systems for chemicals to ensure frictionless movement of goods within the island of Ireland, whilst remaining within the UK customs territory. NI businesses will retain their current EU REACH status a
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Vietnamese National Chemical Inventory (NCI) Notification window opened on 16th October 2020 and is about to close on 15th April 2021. Vietnam began to compile the national chemical inventory (NCI) in 2012. Substances that are not listed on th
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The Ministry of Environment (MoE) in South Korea has announced late pre-Registration criteria on 23 February. Existing substances are chemicals that have been circulated in South Korea before 1991 or nominated by the MoE after the hazards assessment
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The Ministry for Development of Economy, Trade and Agriculture of Ukraine has notified the draft resolution, On Approval of the Technical Regulation on Safety of Chemical Products, to the WTO. This draft resolution lists out requirements for registra
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The Hazardous Substance Act B.E. 2535 is one of the main legislative bases involved in chemical management in Thailand. The first issue of B.E. 2535 came into force on April 7th, 1992. The Act has been revised several times. The Ministry of Indus
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Brazil is the world’s largest user of pesticides and has been the market for many agrochemical companies. The Brazilian Health Regulatory Agency (ANVISA), agency responsible for toxicological assessment, submitted several modification p
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The Law Bill 6.120/2019 is in possession of the Environment and Sustainable Development Commission (CMADS) of the Deputies’ Chamber since early December 2019, aiming to create the National Inventory of Chemical Substances in order to consolidat
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On 23rd March 2021, Chinese National Medical Products Administration (NMPA) launched a new platform for the Registration and filing of cosmetics to support the implementation of ‘Cosmetic Supervision and Administration Regulation (CSAR)’ and
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The Australian Industrial Chemicals Introduction Scheme (AICIS) has been implemented since July 1st 2020. Under this Scheme, introducers of chemicals have the obligation to submit an annual declaration. The first deadline of the annual declaratio
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' In an email exchange with GPC dated April 2nd, 2021, HSE provided a much-welcomed clarification regarding the requirements that non-GB manufacturers must meet in order to qualify for DUIN. In their email, HSE stated that DUIN is only avai
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Taiwan’s Environmental Protection Administration (EPA) has published the modification of the fee structure for chemical Registration on April 7, 2021. In response to the international trend of reducing the use of animal testing, the registratio
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The entry into force date of Eurasia REACH has been postponed. The regulation was initially planned to come into force on 2nd June 2021.  This postpone is mainly due to the delay of the approvement of the second part of Eurasia REACH regulation
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The Ministry of Environment (MoE) in South Korea updated the list of pre-registered substances, which in total becomes 17,096 substances. The list includes 1,800 substances that are manufactured and imported more than 1000 tpa and 78 CMR substances
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The recent partial amendment to K-REACH has been approved by South Korea's parliament on 13 April, and it will be enforced on 14 October. This amendment outlines the culpability of downstream users and resellers that employ unregistered substan
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On May 27 Taiwan’s Environmental Protection Administration (EPA) proposed an amendment to the Regulation on New and Existing Chemical Substances. The regulation was first published in 2014 and had previously been amended in March 2019. The lega
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Companies are recommended to register substances under EU REACH with an appropriate declaration of company size together with supporting documents in REACH-IT system. Qualification of micro, small or medium-sized (MSME) enterprise is listed in
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In a private communication with GPC, UK’s Health and Safety Executive (HSE) provided some clarification on the UK REACH compliance procedures currently available for importers and manufacturers. A great number of GB-based importers and non-GB-ba
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At the XXII Meeting of the Forum of Ministers of Environment of Latin America and the Caribbean on 1-2 February 2021, ministries from six countries in Latin America announced the Action Plan 2021-2024 for Latin America and the Caribbean, aiming to p
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In a meeting held in May 19-20, 2021 (SGT 6), the Mercosur Environment Working Subgroup recommended advancing the regulatory framework within the bloc. The proposal includes the adoption of an updated GHS version and a regulatory harmonization among
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The Ministry of Environment (MoE) in South Korea is consulting on a draft amendment of the K-REACH enforcement decree and rule, which was published on June 3rd. The draft of decree amendment mainly proposes revisions including removing the req
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  The Government has appointed Graeme Barden as the new Executive Director of the nation’s industrial chemicals assessment and regulatory body, the Australian Industrial Chemicals Introduction Scheme (AICIS). The regulatory authority has
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On the 10th of June, EPA proposed a new Per- and polyfluoroalkyl substances (PFAS) reporting rule after the White House Office of Management and Budget cleared it. For producers and importers, this new rule means that they have to 
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Department of Environment (DOE) recently announced its new website for Environmentally Hazardous Substances (EHS) Registration. The platform is for gathering information on EHS identified and notified by importers and manufacturers to DOE. With t
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In April 2021, the Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals, India, published several orders regarding BIS certification of 13 chemicals (see Table below). These chemicals are added to the BIS Mandatory
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In April 2021, the Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals, India, published several orders regarding BIS certification of 13 chemicals (see Table below). These chemicals are added to the BIS Mandatory Cer
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REACH (EC 1907/2006) is a regulation aimed at improving the protection of human health and the environment through a better and earlier identification of the intrinsic properties of chemical substances. (Source: EC) The EC clarification and amendm
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China implemented CSAR in January 2021, and this was after 30 years of waiting. China recently took another massive step by approving its first cosmetics ingredients under CSAR. As recently published in the International Nomenclature Cosmetic Ing
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ECHA added new updates in the Guidance on Registration in August 2021. The new updated version of the guidance document offers advanced support to the companies with their Registration obligations.  The Guidance on Registration was first pu
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ECHA elucidates the rules on accepting adaptations for degradation testing and requiring combined studies for mutagenicity. It also suggests companies should consider these changes while deciding whether to update their Registrations.  Ch
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The Ministry of Health, Turkey published on their webiste the draft regulation on the amendment of Turkish Biocidal Product Regulation.  Current Biocidal regulation came into force on 31.12.2009 in Turkey. The regulation aims to assess the effe
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The 27th October 2021 deadline for submitting a Downstream User Import Notification is approaching fast.   As a reminder, your substances are eligible for DUIN if:  They are registered under EU REACH; and   They were placed on the GB
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The Ministry of Environment (MoE) in South Korea updated K-REACH to simplify data submission for duplicate data requirements. According to K-REACH enforcement rule article 36, chemical substance safety information shall be provided. Especially, wh
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On the 7th of September, 2021, the Chemical Registration Centre in China upgraded its hazardous chemical substance Registration platform based on the module of ’Platform + Application’ mentioned in its 2021 working plan. The system was upgrade
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On the 30th of September, the National Medical Products Administration of China (NMPA) published the final Regulations on the Supervision and Administration of Children’s Cosmetics which is expected to take effect on the 1st of January 20
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In recent months, Chile has announced three main resolutions aimed at defining the goals, obligations, annual report’s content, and the framing of products that would fall within the packing management. Chile is truly embracing the Extended Produc
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In a letter of 9 February 2021, Steve Elliott, Chief Executive of the UK’s Chemical Industries Association called upon the UK government to repeal the UK REACH requirement for duplicate Registration datasets. Under the current situation, companies
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On November 15 and 16, 2021, the Committee on Technical Barriers to Trade, India published and submitted eight chemicals’ notifications to the World Trade Organization (WTO). BIS certification is required by every manufacturer (Indian or foreign
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On November 23rd, 2021, Taiwan’s Environmental Protection Agency amended the Regulations of New and Existing Chemical Substances Registration and extended the submission of 106 PECs to 5 years. Considering the impacts of COVID on the industry, comp
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European Union (EU)  A new Chemicals Strategy for Sustainability was presented by the EU in 2020 as part of the EU Green Deal. This year, there are major implementations that will be made to achieve this strategy as Europe transitions to a toxi
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The directorate of the Revolving Fund of the Ministry of Environment and Urbanization has published the 2022 KKDİK fee on its website. Compared to 2021, the fees have increased by 20%. In 2021, the joint submission fee was lesser than individual
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On 22nd December 2021, the Ministry of Environment and Ecology announced that 11 chemical substances will be added to the Inventory of Existing Chemical Substance list (IECSC) of China. For chemicals included in the chemical inventory list, there
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ECHA regularly recommends substances from the Candidate List to be included in the Authorisation List (Annex XIV to REACH), based on the information in the Registration dossiers on uses and volumes of the substance. On February 2, 2022, ECHA lists
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The Department of Environment (DOE) in the Ministry of Environment and Water, Malaysia launched a new website in April 2021. This new website called ‘MyEHS’ was launched after the department closed its Environmental Hazardous Substance Notific
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On January 31, 2022, the Bureau of Indian Standards (BIS) released a Gazette notification for Extension in the Implementation date of Chemicals under mandatory certification Scheme I. The chemicals with extended implementation dates are Acetic
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The Ministry of Health, Labour and Welfare (MHLW) in Japan recently designated 4-methylbenzenesulfonic acid as a deleterious substance. This is an industrial substance widely used in coating products, polymers, lubricants, and greases. Most impo
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The Ministry of Environment (MoE) in South Korea is consulting on a draft amendment of Designation of Substances Subject to Intensive Control under Enforcement Decree of the Act on Registration and Evaluation of Chemicals (K-REACH), which was publ
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The Norwegian Environmental Agency announced on February 3, 2022, that the duty to declare annual quantities for 2021 is postponed until May 20, 2022. This occurred because the agency is improving the Product Register – the portal for chemical d
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The Department of Chemicals and Petrochemicals (DCPC) in India has pushed back the deadlines for implementing quality control orders (QCOs) issued by the Bureau of Indian Standards (BIS) for five substances. These substances are tagged ‘specialt
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On the 16th of January 2022, China’s Ministry of Emergency Management (MEM) launched a new online platform for the Registration of hazardous chemicals. The previous system launched in 2020 was closed on January 28, after which the new Hazardous
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Till the 16th of March 2022, the Bureau of Indian Standards (BIS) consults on the draft Indian Standard (IS) for 3,4-dichlorophenyl isocyanate. BIS published a daft in February, describing the substance as an organic compound (formula: C7H3CI2NO)
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On the 7th of March 2022, the EU notifies the decision to not approve N-(3-aminopropyl)-N-dodecylpropane1,3-diamine as an existing active substance for use in biocidal products. This decision was made due to the human health risks posed by the sub
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On 16 February 2022, the Ministry of Environment, Forest and Climate Change published the Plastic Waste Management (Amendment) Rules, 2022, amending the Plastic Waste Management Rules, 2016. The Rules brought in Extended Producer Responsibility (E
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On  February 15, 2022, the National Medical Products Administration of China (NMPA) published final measures for cosmetic companies to establish systems for monitoring adverse reactions of cosmetics. It is expected to come into force on October 1
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In February 2022, the Ministry of Food and Drug Safety (MFDS) in South Korea proposed amendments to the ‘Regulation on Safety Standards, etc. of Cosmetics’. This is the cosmetics policy enacted in 2015 to guide the manufacture and import of co
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The Department for Environment, Food and Rural Affairs (DEFRA), UK in March 2022 published guidance for data and information sharing of the same chemical substance. This guidance will help companies and individuals understand their obligations pursua
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Health Canada has recommended several changes to the pest control products regulation which would reduce the burden on administrative and regulatory laws. Recommended Changes include the following: Extension of the validity period for cert
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The National Institution for Food and Drug Control of China (NIFDC) published the draft revision of “Safety and Technical Standards for Cosmetic” (Safety Standards) on March 31, 2022. This is the first-time revision of the Safety Standards since
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On February 9, 2021, Chile approved its rules for the classification, labeling, and notification of dangerous chemical substances and mixtures (Decree 57) in the official gazette. Decree 57 was promulgated in November 2019 and communicated to�
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In September, Chile reaffirmed commitments with the Latin American Regulatory Cooperation Forum (LARCF), an association promoting dialogue and information exchange, training initiatives, and regulatory cooperation through national chemi
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The Brazilian Deputies’ Chamber approved Law Bill 6.120/2019, which proposes the creation of a national chemical inventory aimed at consolidating information of chemicals present and imported into the national market.  The Law Bill, once in po
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After four years of drafting the framework, Colombia finally promulgated a robust chemical management regulation. Decree 1630, published on November 30, 2021, sets the ground for implementing a national chemical inventory.  Decree 1630/2021 
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The Ministry of Environment (MoE) in South Korea is consulting on a draft amendment of Designation of Toxic Substances under Enforcement Decree of the Act on Registration and Evaluation of Chemicals (K-REACH). The draft amendment mainly proposes r
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Exports and products involved with perfluorooctanoic acid (PFOA), its salt forms, and PFOA-related compounds are banned after the European Commission makes addition to Annex V of the Prior Informed Consent (PIC) Regulation. Echoing the Stockholm Conv
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Recently, the Bureau of Indian Standards (BIS) published several updates for BIS standards. The updates address the following:   Grant of All India First License for “Plastic-Acrylonitrile-Butadiene styrene (ABS) Moulding and Extrusion Ma
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On April 22, 2022, China National Center for Food Safety Risk Assessment (CFSA) announced a consultation notice on approving two new resins used in food contact materials and an expanded use of one food contact material additive.   The concer
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On April 27, 2022, the General Department of the National Medical Products Administration (NMPA) extends the deadline for submitting certain data under the cosmetic regulation from May 1 until December 31. This decision was made due to the rising ca
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The Australian Government published a variation of specific information requirements regarding 1H-1,4,7-triazonine, octahydro-1,4,7-trimethyl- (CAS No. 96556-05-7) on May 4, 2022. The modification and publication are done in accordance with Section 9
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The Australian authority on the 13th of May 2022 announced the addition of six chemicals to the Australia Inventory of Industrial Chemicals (AIIC). The assessment certificates of these chemicals have been issued according to Section 82 of the Industr
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The Brazilian Health Regulatory Agency (ANVISA) is responsible for regulating and approving guidelines and use of pharmaceutical drugs, sanitary standards, and regulation of the food industry. In the last month, ANVISA has proposed modifications to a
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Health Canada has released a proposal for public comment to create a unified regulatory framework for disinfectants and sanitizers. In Canada, biocidal products are currently governed by distinct regulatory systems. Surface sanitizers are governed
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The Thailand Department of Industrial works and Ministry of Industry Recently published a notification, in the Royal Gazette on 11 April 2022.  This notification is referred to as “Notification of Department of Industrial works regarding criteria
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The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the results of hazard review of chemical substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH). The draft amend
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According to ECHA, the once selected substance silver-polyethylenimine-chloride, as a new chemical to join in the biocides review programme now needs some new concerned business bodies to continue its approval process. The original uses applied fo
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The overhaul to “short form” warnings under Prop 65 is temporarily paused in California, the US. The Office of Environmental Health Hazard Assessment (OEHHA) has decided to keep on hold this controversial proposal and instead issue an alternative
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On the 10th of June 2022, ECHA added an entry on n-(hydroxymethyl)acrylamide (NMA) to the REACH candidate list. This addition was done due to the carcinogenic and genotoxic properties of the chemical, posing possible threats to cause cancer or geneti
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Following the “One enterprise, one chemical product, and one QR code” principle, China’s new Hazardous Chemical Registration Comprehensive Service System was launched on February 16, 2022. It supports registry of hazardous chemicals with the au
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According to Notice No.15 of 2022 issued on May 24, 2022, by the General Office of the State Council of the People’s Republic of China, a newly approved Action Plan for New Pollutants Treatment was released aiming to improve China’s new pollutant
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The Ministry of Environment, Urbanization and Climate Change of Turkey has developed a new website to search for information regarding the inventory of chemicals called Chemicals Data System (KIMVES). While the system resembles the substance search
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On May 31, 2022, the Colombian Ministry of Commerce (MINCIT) officially launched the Online Portal for Chemical Substances for Industrial Use. The Online Portal will be the main instrument for the industry to submit chemical information to the author
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In May 2022, the Brazilian National Health Surveillance Agency (ANVISA) modified the procedures for low-risk sanitizers issuing Resolution of the Collegiate Board (Resolução da Diretoria Colegiada -RDC) 692 . The change is intended to facilitate t
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China is the world’s largest fertilizer manufacturer and consumer. Every fertilizer produced or used in China must meet certain regulations and standards, as regulated by the Ministry of Agriculture and Rural Affairs (MARA) and the Secretariat of F
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Contents: Registration requirements (Registration types and documents required) Post-Registration management
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*This webinar will be held in Turkish. Turkish description is below.As you may know, the 5th Draft of the Indian Chemicals Management and Safety Rules (CMSR) is in circulation. It is expected that Indian CMSR will come into force this year and will r
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As you may know, the 5th Draft of the Indian Chemicals Management and Safety Rules (CMSR) is in circulation. It is expected that Indian CMSR will come into force this year and will require notification (with additional data requirements) of all subst
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The main regulation of chemical management in Taiwan is the Toxic Chemicals and Concerned Substances Control Act (TCCSCA) amended in 2019 and came into force on January 1, 2020. Manufacturers or importers of substances have the obligations of Phase O
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Welcome to our webinar on "Comply with UK-REACH: How can companies prepare" organized by Global Product Compliance(GPC) and Indian Chemical Council(ICC). The EU REACH Regulation was brought into the UK law on 1 January 2021, and this is known as U
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Welcome to our webinar on "Chemical Regulatory Updates in Latin America" organized by Global Product Compliance(GPC) and Indian Chemical Council(ICC). Chemical policies are rapidly developing in South America. The trade blocks, as well as the indu
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Welcome to our webinar on "Moving Forward in KKDIK: How should companies prepare for Registration process" organized by Global Product Compliance(GPC) and Indian Chemical Council(ICC). The description of the webinar: KDIK is an acronym in Turkish
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Welcome to our webinar on "How to comply with K-REACH" organized by Global Product Compliance(GPC) and Indian Chemical Council(ICC). The description of the webinar: The Act on Registration and Evaluation of Chemical Substances (known as K-REACH)
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Session 1: How to comply with chemical regulations in China?   The Measures for the Environmental Management Registration of New Chemical Substance (MEE Order 12) which is also known as 'New China REACH' has been carried out for over 2 year and
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Session 1: Introduction of New Pesticide Registration in China  As China's pesticide Registration policy is gradually tightening, it will become more difficult to register pesticides in China in the future. Therefore, it is important for enterpr
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Background As Chemical policies are rapidly developing across the world, industries have witnessed an increasing need for compliance support. As knowledge partner to the Confederation of Indian Industry (CII), Global Product Compliance (GPC) is ho
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Welcome to our webinar on "All you need to know about BIS Certification for Chemicals" organized by Global Product Compliance(GPC). The BIS of BIS Certification stands for Bureau of Indian Standards. The establishment of a national standards body
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The format and content of Safety Data Sheets (SDS) are set by the Code of Practice for the Preparation of Safety Data Sheets for Hazardous Chemicals. Following are some important points to note: Standard 16-SE
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If a new chemical is introduced to the Australia which is exempt from notification or under permit or certificate then annual report or online declaration must be submitted. Annual reporting date is 28 September 2019. Annual reporting can be submit
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Chemicals introduced solely for research, development or analysis in quantities of not more than 100kg/year Chemicals introduced at a port or airport that remain subject to Customs and Border Protection Service control, are
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The main obligation is on the Australian Manufacturers and importers. Registration of Industrial chemical introducers: Under AICIS, introducers of industrial chemicals shall register their businesses before the introduction of industrial chemicals.
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This Act establishes the AICIS (Australian Industrial Chemicals Introduction Scheme), and an Executive Director, to control the manufacture or import of industrial chemicals. The industrial chemical means any chemical element, a compound
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An annual declaration must be submitted by the introducers to the authorities for the introductions made during the Registration year and the categorization. For chemicals falling with the scope of reported introductions, a one-off pre-introduction
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The Canadian Environmental Protection Act, 1999 (CEPA 1999) is an important part of Canada's federal environmental legislation aimed at preventing pollution and protecting the environment and human health. The goal of CEPA 1999 is to contribute t
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- Mixtures - Manufactured items - wastes - Substances carried through Canada - Polymers subject to 2% rule - Proteins subject to 2% rule
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The Measures for Environmental Management of New Chemical Substances. A brief Overview of Chemical management in China: The regulatory affairs in China is mainly influenced by the US and EU-REACH regulations. The M
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The Inventory of Existing Chemical Substances in China (IECSC) is the official inventory maintained by MEP, China which lists the substances, which are presently registered under CHINA REACH under various notification types till 2016. Article 3 of t
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There are certain chemicals that are exempt from notification, even if they meet the definition of new chemical in China. Any potential notifier should confirm if the substances fall into the range of exemption before starting the Registration pr
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Receiving and Evaluation Authority: The New Substance Notification receiving and decision authority rests with the Ministry of Ecological Environment, People’s Republic of China. Application Conditions: The basic situation of any simple decl
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European Unions (EU) Registration, Evaluation, Authorization (Restriction) of Chemicals (REACH) Regulation Background : REACH is a regulation of the European Union, adopted to improve the protection of human health and environment from the risk
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REACH will be governed by a nodal agency known as European Chemical Agency (ECHA). ECHA is the driving force among regulatory authorities in implementing the EU's ground-breaking chemicals legislation for the benefit of human health and the environm
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REACH establishes procedures for collecting and assessing information on the properties and hazards of substances. Companies need to register their substances and to do this they need to work together with other companies who are registering the same
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The total Registration costs mainly consist of three parts: Data fees paid to lead registrant or Consortium to purchase letter of access to refer to the common parts of Registration dossier. The fee is tonnage dependent. Data fee v
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The competent authorities of the Member States shall cooperate with each other and with the Commission to ensure proper application and due enforcement of this Regulation and shall transmit to each other, all information necessary with a view to appl
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Animal Testing Prohibited : The Cosmetics Directive provides the regulatory framework for the phasing out of animal testing for cosmetics purposes. Specifically, it establishes: Testing ban - prohibition to te
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Everyfood business operator involved in the manufacturing, processing, storage distribution and sale of food products must compulsorily obtain FSSAI Registration or License. FSSAI Registration is different from�
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FSSAI Registration or license is based on the business volume and premises. Depending upon the installed capacity or turnover or location, applicant premises are eligible for the license such as central license, state license, regis
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Common documents required for obtaining FSSAI Registration: FormA – completed and signed PhotoIdentity of FBO Proofof possession of premises (e.g
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For all other FBO apart from small-scale business, FSSAI license must be obtained. FSSAI License canbe classified into two categories e. State FSSAI License & Central FSSAI License based on the size of the b
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FormB duly completed and Planof the processing unit showing the dimensions and operation-wise area Listof Directors/ Partners/ Proprietor with address, contact d
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The FSSAI regulatory body is independent of appointment of OR as Registration and licensing procedurefor the target country and non-target country is Although,assistance on Registration can be
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Pesticide is a substance, which is used for destroying insects or other organisms harmful to cultivated plants or to animals. India is the 4th largest country in the production of pesticides next to USA, Japan and China. Indian pe
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There are mainly three types of Registrations. Provisional Registration under sections 9(3b) : Provisional Registration is done for the chemical/molecule which has been introduced for the first time in India.The Registration is usually granted f
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9(4)”Me Too” Registration – Min 180 Days. 9(3) and 9(3b)- fresh Registration – Min 365-1095 days
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The regulatory agency responsible for the Registration of insecticide & pesticide is the Central Insecticides Board & Registration Commitee (CIBRC). Central Insecticides Board & Registration Committee (CIBRC) under the Directorate of Plant
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Type and depth of data requirements depends on category of pesticide (Category I-IX). Category Desciption I Technical grade pesticide, which is not registered for manufacturer/ Import and use in india II Technical
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The Act on Registration and Evaluation, etc of Chemical Substances (known as K-REACH) aims to protect public health and the environment. This is achieved by four procedures, namely notification or Registration, evaluation, authorization, and restri
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Under K-REACH, any person who intends to manufacture or import a new chemical substance or at least one ton per year of an existing chemical substance shall register the chemical substance ("Registration") according to the following requiremen
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Ony Representative (OR) is an intermediary, and is mandatory for companies based outside of South Korea wishing to register the substance they export to South Korea. Foreign companies may appoint Korea-based ORs to fulfil relevant obligations unde
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K-REACH pre-Registration start from 1 Jan 2019 and end on 30 June 2019. It is required all >=1t/y existing chemical substances manufactured in or imported to South Korea. Only those pre-registered existing substances can benefit from Registration gr
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According to the article 10 of amended K-REACH regulation, any person who intends to manufacture or import a new chemical substance or at least one ton per year of an existing chemical substance shall register the chemical substance before he or she
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Similar to SIEF in EU-REACH, CICO (Chemicals substance Information Communicative Organization) includes a group of potential registrants of one substance. The role of each participant is to strive for an efficient Registration and communication proce
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 ITEMS EU REACH K-REACH Registration target New substance (>=1t/y) Existing substance (>=1t/y) New substance (>=100kg/y) Existing substance (>=1t/y)
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Eurasian Economic Union members; Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia created a common Technical regulation 041/2017 "On chemical product safety" (inofficially called Eurasia REACH). This technical regulation introduces new require
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The compliance assessment with the requirements of the TR 041 is carried out in one of the following ways: Notification Registration  For substances that are listed (e.g. notified) in the Eurasian chemical inventory: that do not 
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On 16 January 2019, Taiwan has amended the country’s toxic chemical law from Toxic Chemical Substance Control Act and renamed it to Toxic Chemicals and Concerned Substances Control Act (TCCSCA). On March 11 2019, Taiwan’s Environmental Protecti
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From 1 January 2020, manufacturers or importers who manufacture or import Existing Chemical Substance in an annual amount of 100 kilograms or more, should apply for the Phase One Registration within 6 months from the date of manufacturing/importin
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Chemical Inventory in Taiwan Taiwan’s Chemical substance Inventory (TCSI), was compiled jointly by two competent authorities, the Environmental Protection Administration and Ministry of Labor. The inventory contains more than 100,000 substances
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Substance Type Deadlines Existing Substance Registration within 6 months of manufacture/import (M/I) tonnage exceeding 100 kg per year Existing Substance (106 PECs) Phase
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There are over 1,585 entries in current Hazardous Substances List in Thailand covering various chemicals that are controlled by various authorities (including pesticides and biocides). This list is issued and maintained by the Ministry of Industry (M
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An application for Registration of following hazardous substance should be submitted to the Department of Industrial Works (DIW) of MOT, or to other authorities designated by MOI by the producers or imports of below hazardous substance type:
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Hazard Substance Manufacturer Hazard Substance Importer
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HSCA Amendment In 2013, an amendment in the project is initiated by DIW to improve the current version by identifying the existing hurdles and consulting all stakeholders. Several highlights of the amendment could include:
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The purpose of KKDIK is: To regulate the administrative and technical procedures and principles regarding the Registration, evaluation, authorization and restriction of To ensure a high level of protection of human health and the To promote
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All substances that are in scope of KKDIK have to be registered and pre-registered if they are produced or imported more than 1 ton per year unless they are exempt. Substances that are not pre-registered until the deadline will not be allowed to be p
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The appointment of a US Agent is a mandatory requirement for foreign companies who wish to sell drugs or pharmaceuticals, medical devices, food and dietary supplements, in United States. U.S. agent and roles and responsibilities of the U
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Section415(a)(3) of the FD & C Act requires facilities that are required to register with FDA to renew their Registrations every other year, during the period beginning on October 1 and ending Contains (Nonbinding Recommendations 37) on
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UK REACH - What needs to be done? Post transition period, the EU REACH Regulation will be brought into UK law by the European Union (Withdrawal) Act 2018. This Regulation, and related legislation, will be retained in the UK with the changes necess
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India released the fourth draft Chemicals (Management and Safety) Rules to selected groups on March 16, 2020. This fourth draft is believed to be the final draft, despite assurances in February that the third draft was the final draft. The draft Rul
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Indian Chemicals (Management & Safety) (ICMS) Rules covers the following critical compliance criteria:  ICMS Rules applies to all substances, substances in mixtures and Intermediates that are manufactured, imported, placed, or intended to be pla
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Notifier or Registrant may request that trade secrets, proprietary business information and other intellectual property related data and information shared by the Notifier or the Registrant be kept confidential and not be disseminated publicly. A re
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All the manufacturers, importers and Authorized Represenatative (in case of Foreign manufacturer) that have placed or intending to place a substance listed in Scheule VI in Indian territory in quntities greater than 1 ton per annum must register subs
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To be eligible to nominate, companies must have a legally registered business entity in Vietnam. A tax identification number will be required for online Registration.  GPC through its Vietnamese affiliates can help you with the NCI nomination fo
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There are four level of involvement which is available within CICO as described below 1) Lead Registrant Lead whole process of consortium operation as a consortium leader Advantage: When additional members join the consortium, he/she o
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Registration of new chemical substances was transferred from TCCA to K-REACH from 1 Jan 2015. All new chemical substances regardless of tonnage are required to be registered. However, a Simplified Registration with less data requirements is appli
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Once the national existing chemical substance inventory has been finalized, chemical substances which are not listed will be regarded as new chemical substances. Manufacturers and importers of >=1t/y new chemical substances need to register those new
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A new substance is defined a substance that is not listed on EINECS (European Inventory of Existing Commercial Chemical Substances). This inventory includes chemical substances deemed to be on the European Community market between January 1, 1971 and
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The ChemO has also adopted GHS by requiring suppliers to classify, label and package hazardous substances and preparations in accordance with EU CLP regulation. In the meantime, manufacturers and importers are required to submit the classificati
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The substances and preparations that are hazardous or PBT/vPvB or on Swiss SVHC candidate list,and even if qunatity is
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Polymers (but not the monomers) are exempted from the notification obligation under ChemO and from Registration obligation under REACH. Within the scope of self-regulation, the notifier must check this (in case of uncertainty, it may ask his supplier
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No deadline specified in the regulation New Substances: The new substance >1 MT has to be notified before placing into the market PPORD substances: The new substance >1 MT has to be declared before placing into the market Registration: The
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Correctness of the data provided in the notification; Refusing Field Inspection by authorities, processing new chemicals without Registration certificates – all amount to heavy fines and severe punishments by MEP. If the domestic testing agen
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Post Registration Obligations: After notification is completed, a Registration certificate containing specific management category will be issued. Certificate holder needs to fulfill different post-notification obligations depending on
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According to the Administrative Licensing Law, the applicant has the following rights according to law: If the applicant meets the statutory conditions and standards, the applicant has the equal right to obtain an administrative license accordi
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Certificate holder that has not engaged in manufacturing or importation activities or has stopped manufacturing and importation may withdraw their application of Registration certificate, explain it and hand back the Registration certificate. ME
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Any registrant who, in violation of this Provision, hides relevant information or provides false application materials in the application for the Registration certificates shall be subject to a fine of RMB10,000 at least and RMB30,000 at most, by the
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Any registrant who, in violation of this Provision, has one of the following wrongful acts shall be subject to a fine of RMB10,000 at least and RMB30,000 by the local environmental protection authorities. In this case, the local authorities shall rep
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Any registrant who, in violation of this Provision, has one of the following wrongful acts shall be subject to a fine of RMB10,000 at least and RMB30,000 by the local environmental protection authorities. In this case, the local authorities are empow
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Details required to register polymer as a new substance in CHINA Exact IUPAC name of the polymer - "Before searching IECSC, it is very important for a company to know the nomenclature rules in China. The Chinese name of a polymer should be name
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The Measures for the Registration of Environmental Management of New Chemical Substances were approved by the Ministry of Ecological Environment on February 17, 2020 and are hereby promulgated, effective January 1, 2021. The Measures for the Environm
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Article 1 These Measures are formulated in accordance with relevant laws and regulations and the Decision of the State Council on the Establishment of Administrative Permits for Administrative Approval Projects that are necessary to retain new chemi
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Article 4 The State shall implement a system of environmental management and Registration of new chemical substances. The Registration of environmental management of new chemical substances is divided into routine Registration, simple registratio
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Article 7 Enterprises and institutions engaged in the research, production, import and processing of new chemical substances shall abide by the provisions of these Measures, take effective measures to prevent and control the environmental risks of n
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Article 10 Where the annual production of new chemical substances or the import volume of more than 10 tons, the general Registration of environmental management of new chemical substances shall be conducted (hereinafter referred to as the regular r
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Article 11 An applicant for the Registration of environmental management of new chemical substances shall, in accordance with the law within the territory of the People's Republic of China, be able to bear legal responsibility independently, and
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Article 13 If the applicant believes that the Registration application or filing materials submitted by him involve trade secrets and requires information protection, it shall submit it at the time of application for Registration or filing, and subm
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Article 14 The domestic testing institutions of the People's Republic of China that provide test data for the Registration of new chemical substances for environmental management shall, in accordance with law, obtain the qualification of the ins
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Article 15 Where an application is made for routine Registration, the applicant shall submit the following materials: (1) The application form for regular Registration; (2) The physical and chemical properties of new chemical substances, healt
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Article 16 Where an application is made for a simple Registration, the applicant shall submit the following materials: (1) The application form for simple Registration; (ii) The physicochemical properties of new chemicalsubstances, as well as
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Article 17 The same applicant may apply for Registration for environmental management of new chemical substances with similar molecular structures, similar uses or similar test data. The number of applications for Registration is determined by the s
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Article 18 After receiving the application materials for environmental management Registration of new chemical substances, the competent department of ecology and environment under the State Council shall deal with them according to the following cir
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Article 19 After accepting the application for routine Registration, the competent department of ecological environment under the State Council shall organize an expert committee and the technical institution for the environmental management of chem
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Article 20 After accepting the application for simple Registration, the competent department of ecological environment under the State Council shall organize the technical institution for the environmental management of chemical substances to which
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Article 21 The competent department of ecological environment under the State Council shall examine the technical evaluation opinions of the regular Registration and make a decision on the following circumstances: (1) If unreasonable environmenta
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Article 22 The competent department of ecological environment under the State Council shall examine the technical evaluation opinions on simple Registration and make a decision on the following circumstances: (1) If no one has been found to be pe
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Article 23 If any of the following circumstances occur, the competent department of ecological environment under the State Council shall not register, notify the applicant in writing and explain the reasons: (1) using deception such as concealmen
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Article 26 The Registration certificate shall specify the following items: 　　 (1) Type of Registration certificate; 　　 (2) The name of the applicant and its agent; 　　 (3) Identification information such as Chinese and English names
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Article 29 Before a new chemical substance that has obtained a regular Registration certificate is listed in the "Inventory of Existing Chemical Substances in China" in accordance with Article 44 of these Measures, the holder of the Registration cert
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　 Article 31 The following chemical substances listed in the "Inventory of Existing Chemical Substances in China" in accordance with Article 44 of these Measures shall be subject to new-use environmental management: 　　 (1) Highly hazardous c
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 Article 33 After obtaining the Registration certificate, the applicant may apply to the State Council department in charge of ecology and environment to cancel the Registration certificate. 　　Article 34 In one of the following situations, for
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Article 38 Producers, importers and processing users of new chemical substances shall convey the following information to downstream users: (1) the Registration certificate number or the record receipt number; (2) The application for use of ne
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Article 41 The holder of the Registration certificate shall report the first activity of the new chemical substance to the competent department of ecological environment under the State Council within 60 days from the date of the first production or
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Article 42 If researchers, producers, importers and processing users of new chemical substances discover that new chemical substances have new environmental or health hazard characteristics or environmental risks, they shall promptly report them to
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　　 Article 44 If a new chemical substance that has obtained a regular Registration certificate has reached five years from the date of its first Registration, the State Council department in charge of ecology and environment shall include it in
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　 Article 44 If a new chemical substance that has obtained a regular Registration certificate has reached five years from the date of its first Registration, the State Council department in charge of ecology and environment shall include it in the
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Article 46 Anyone who, in violation of the provisions of these Measures, obtains the Registration of environmental management of new chemical substances by improper means such as deception or bribery shall be ordered by the competent department of e
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Chapter VI Supplementary Provisions 　　 Article 52 The meaning of the following terms in these measures: (1) Environmental risk refers to the degree and probability of harmful effects on the environment and health after chemical substances with
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 A manufacturer or importer (introducer) of industrial chemicals or products that release industrial chemicals — into Australia for commercial purposes must register their business if not alread registered with previous regulation NICNAS. This
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Any chemical material/object containing chemicals placed into EU market need to comply with the REACH regulation. The chemical substances have the Registration obligation whereas objects/articles containing chemicals have separate set of obligation.�
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The BIS in BIS Certification stands for Bureau of Indian Standards. The establishment of a national standards body in India is based on the Bureau of Indian Standards Act established in 2016.   The aims of the BIS Act include harmonious developm
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  The main authority that is responsible for the Registration, approval or restriction of agrochemicals sold in Australia is Australian Pesticides and Veterinary Medicines Authority (APVMA). The regulation of the use of pesticides is regulated by E
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Law 7802 (Pesticide Law) established Brazil's current pesticide legislative framework, which governs pesticide research, experimentation, production, packaging, labelling, transportation, storage, marketing, commercial-advertising, utilization, i
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The applicant must submit the application and its attachments in triplicate to the above-mentioned federal agencies in the agriculture, health, and environmental sectors. The applicant must submit the application and its attachments in triplicate
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After Submission for the Registration:  1. Submission of the product Registration will be reviewed by all the Authorities. 2. MAPA expresses an opinion on whether the proposed product is appropriate to reduce the Efficacy Evaluation, Phytotoxicity
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China's State Council published the final version of the COsmetic Supervision and Administration Regulation (CSAR) and this came into force on 1 January 2021 and replaced the Cosmetic Hygiene Supervision REgulations. CSAR regulates all cosmeti
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Cosmetic raw material is defined as natural or synthesis ingredients which are used in making cosmetic products. According to the requirements, existing ingredients need to do record filing submission, while new ingredients must do a formal registra
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The Registration timeline of cosmetic products is the same as cosmetic ingredients Registration. But the submission documents are different. For cosmetic products Registration, applicants need to prepare: The name, address, and contact informatio
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For imported cosmetics, they must be labeled in Chinese and contain the following information: Product name, special cosmetics Registration certificate number The name and address of the registrant, recorder, and entrusted production enterprise
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CSAR also introduces the annual reporting requirements. Applicants should submit the annual report of cosmetics from January 1 to March 31 each year. Basic information and production of new cosmetic ingredients. Information on cosmetic registran
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The Department of Agriculture, Forestry and Fisheries (DAFF) is responsible for the Registration of pesticides in South Africa. Pesticides are regulated under the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36
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The Department of Agriculture, Forestry and Fisheries (DAFF) is responsible for the Registration of pesticides in South Africa. Pesticides are regulated under the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36
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Fertilizers and Farm Feeds Parliament approved the Agricultural Remedies and Stock Remedies Act in 1947, which regulates pesticides and their use, among other things. The Act has been changed several times since then, but it has never been comprehens
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Registration consists of the following steps: Five batch analytical reports are used to verify chemical and toxicological equivalency. Data from a GLP (Good Laboratory Practice) approved independent laboratory is required. Details about the pr
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On December 31, 2021, China’s National Medical Product Administration (NMPA) launched an online cosmetic ingredient submission platform. This platform, Cosmetic Ingredients Safety Information Registration Platform, will require companies handing ex
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On December 31, 2021, China’s National Medical Product Administration (NMPA) launched an online cosmetic ingredient submission platform. This platform, Cosmetic Ingredients Safety Information Registration Platform, will require companies handing ex
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Cosmetics Raw Material manufacturers, domestic or overseas, are required to submit to the Cosmetic Ingredients Safety Information Registration Platform. Manufacturers can submit information by themselves, or they can appoint an authorized representat
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Companies seeking to export an EU-registered substance to the GB market, who also placed that substance on the GB market in 2019-2020:  Such exporters may submit a Downstream User Import Notification (DUIN) to HSE. By notifying their substance via
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Anyone who is registered under AICIS to introduce industrial chemicals or products containing industrial chemicals (for example, cosmetics, paints and plastics) must submit an annual declaration. This applies to all of your chemical introductions, r
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No. Registration Condition Note 1 New TC/TK Technical material containing new active ingredient which was not yet registered in China 2 Me-too TC/TK
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Product Chemistry: Methods and validation for identification and content determination of limited components such as softener, stabilizer and synergist were added. Conformity between data/sample and actual production process will be carefully scr
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Even though China is not an OECD member nor a signatory to the OECD MAD (Mutual/Multilateral Acceptance of Data) programme, test results from abroad OECD-GLP laboratories were previously accepted. China has decided to "level the playing field" in the
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In the Cosmetics Rules, 2020, the cosmetics' definition remains the same.However, the concept of "New cosmetic" is introduced for the first time. It is defined as ‘a cosmetic that contains a novel ingredient that has not been used anywhere
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The Australian Pesticides and Veterinary Medicines Authority is responsible for the Registration, approval, and restriction of agrochemicals sold in Australia (APVMA). The use of pesticides is regulated by the Environmental Protection Agency (EPA) un
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The FDA does not “certify" devices, and the FDA logo is for the official use of the FDA and not for use on private sector materials. The FDA does not issue Registration certificates to medical device facilities nor does the FDA certify info
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The Environmental Protection Agency regulates pesticides on a national level in the United States (EPA). The Federal Insecticide, Fungicide, and Rodenticide Act, as well as the Federal Food, Drug, and Cosmetic Act, give pesticides broad regulatory ju
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The Environmental Protection Agency regulates pesticides on a national level in the United States (EPA). The Federal Insecticide, Fungicide, and Rodenticide Act, as well as the Federal Food, Drug, and Cosmetic Act, give pesticides broad regulatory ju
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The Registration of a pesticide is a scientific, legal, and administrative process consist of examination of pesticide's ingredients, the specific site or crop where it will be used, the amount, frequency, and timing of its application, as well a
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Human Health risk  a. Risks in the aggregate–from food, water, and residential uses  b. Risks accumulated over time from several pesticides with similar effects  c. Occupational hazards for people who use the product at work  Env
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Before a pesticide can be sold or disseminated in the United States, the FDA must approve all label text as part of the licensing/Registration procedure. The label's overarching goal is to provide clear instructions for efficient product performa
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https://www.epa.gov/pesticide-Registration/about-pesticide-Registration#:~:text=Federal%20Insecticide%2C%20Fungicide%2C%20and%20Rodenticide%20Act%20(FIFRA)%20%2D,benefits%20of%20a%20product's%20use
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Chemicals Strategy for Sustainability  The European Commission presented its Chemicals Strategy for Sustainability in October 2020, with an overarching goal of eliminating or minimizing the use of hazardous substances. This is expected to bring pos
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Chemicals Strategy for Sustainability The European Commission presented its Chemicals Strategy for Sustainability in October 2020, with an overarching goal of eliminating or minimizing the use of hazardous substances. This is expected to bring posit
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India plant protection product Registration is intricately challenging task due to various categories of Registration.   Identifying a suitable category for your product needs to be established and it some time happens with the conformi
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1. Study of guidelines displayed on official website of CIB&RC.  2. Generation of chemistry, toxicological, packaging, bio-efficacy data as per latest guidelines.  3. Submission of online form 1 along with required data.  4. Preliminary scrutin
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A notified body is an organization designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislat
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The data requirements are set out in Regulation (EU) No. 283/2013 for the active substance and in Regulation (EU) No. 284/2013 for the product formulation along with national requirements which are specific to each Member State. However, writing EU r
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A Saudi Food and Drug Authority e-administration that empowers recipients to access and issue a connected authentication on general wellbeing pesticides.    • Login and switch on record.    • Access the information of the association.
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Background  Earlier manufacturers could sell medical devices in India without any jurisdictions. Since 2006, medical device regulations have been put forth by the Indian government through the CDSCO where all the devices entering the country
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Following provisional clearance for limited use, the pesticide Registration procedure begins with two years of testing and inquiry. An advisory committee comprised of representatives from several ministries, including Environmental Protection, Health
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The China Food & Drug Administration (CFDA), now called the National Medical Products Administration (NMPA), is responsible for medical devices, drugs, and healthcare services. The organization is headquartered in Beijing, with offices in e
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The China Food & Drug Administration (CFDA), now called the National Medical Products Administration (NMPA), is responsible for medical devices, drugs, and healthcare services. The organization is headquartered in Beijing, with offices in e
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Applicants needs to provide the summary of risk assessment:​  Quality of the data referenced for hazard assessment (e.g., Experimental design and quality of the critical study or studies).​  Kenya Good agricultural practice (GAP
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Introductory fee of KS 10,000 to obtain an experimental permit.  A certificate of Registration will cost the applicant $347.40 (KSh30, 000)  While a renewal certificate of Registration not exceeding two years costs $231.60 (KSh20, 000
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  Product Identity - The product name and trade name(s) must be included in each authorization of a biochemical PCA that is a pesticide product (if different). It's possible to provide the corporate code number(s).  Confidential St
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Assume that at any point throughout the manufacturing process, the existence of components harmful or sensitizing to humans or other non-target mammalian species is detected. In that instance, data must be supplied demonstrating that the chemicals ar
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In June 2021, the NMPA issued a new set of regulations that will make it easier for innovative medical devices for the treatment of urgent public health emergencies and rare diseases to obtain approval in China.   Certain products will be
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Product Risk Analysis Document  Product Technical Specification  Product Testing Report (company’s self-testing report or 3rd party report)  Clinical Evaluation Report  Key Manufacturing Information (process, flowchart, material, etc.) 
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Plant Protection Products (PPPs) are registered according to PPPs regulation; 27885/25.03.2011.   1. According to the above regulation, applicants must receive a certificate showing their commercial activity in the Pesticides Industry from the Min
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There are three types of Registration procedures according to the regulation on PPP:27885/ 25.03.2011.   The first is when a formula is presented with the latest active ingredients. Applicants for this sort of application should also produce
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It is generally expected that the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) will be adopted for pesticides. The biggest impact of GHS on pesticides will be pesticide classification and product labels. While G
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The pesticide legislation and regulations in the countries share the following basic concepts:  * Submission of application to register for pesticide use, with required data and other information, and a draft of a label; * Formation of a Technical
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The pesticide legislation and regulations in the countries share the following basic concepts: * Submission of application to register for pesticide use, with required data and other information, and a draft of a label; * Formation of a Technical A
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Register one trade name for each active ingredient, technical-grade drug or finished product for pest prevention and control or crop growth regulation. In case such active ingredient, technical-grade drug or finished product is used for disinfectio
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The labeling requirements of the countries implementing a Registration system are almost completely harmonized based on Relevant FAO guidelines: All countries require the printing of labels in both the national language and the dialect of the loc
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The Regulations for Pesticide Registration were promulgated in 1992 by the Ministry of Agriculture and Food Industries; the Plant Production and Protection Department (PPPD) became the implementing authority. Efficacy protocols have been incorpora
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The Ministry of Agriculture of the Russian Federation No. 357 approves the Registration process of agrochemicals in Russia. The Federal Law based on the “Production and consumption waste”, in compliance with Article 14 every legal entity and in
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  The chemical substances that are sold in the market must be registered in the Russian Federation. The requirement of the Registration is mandatory for the main legal act in the field of environmental protection that is “On Protection of the E
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The Federal Law based on " Production and Consumption Waste" and "On approval of the Federal Waste Classifier ", belonging to the order of the MNR of Russia No.786 differentiates waste based on its origin, physical state, aggregative, hazardous prope
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According to Article 2.3 of the Pharmaceutical Affairs Law, “cosmetics” is defined as articles with mild action on the human body which are intended to be applied to the human body through rubbing, sprinkling or other similar methods, aiming to c
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Pesticides
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Permission for manufacturing or importing samples of products for Registration is required before the Registration process begins. The manufacturer or importer shall submit an application with attachments to FDA for review. The Requirements for Regi
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Within a month of receiving an application, the APVMA conducts a preliminary assessment. This is to see if the application fits the application requirements, in other words, if the applicant has provided the APVMA with all the necessary information a
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The APVMA has yet to issue any formal rules on the Registration and regulation of nanomaterials-containing products. When the person applies to register a product that contains nanomaterials, the basic guideline is that one should include information
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On the Environmental Protection Agency (EPA) official website, the pesticide is described as “any substance or mixture of substances intended for: Preventing, destroying, repelling, or mitigating any pest. Use as a plant regulator, defoliant,
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As per the data found on “new active ingredient Registration status (2000-2021)” in the pesticide regulations, the following tests/studies were required before the ingredient could be reviewed- Chemical- Silver chloride Phase 1: Product ch
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As per the data found on “new active ingredient Registration status (2000-2021)” in the pesticide regulations, the following tests/studies were required before the ingredient could be reviewed- Chemical- Silver chloride Phase 1: Product chara
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Voluntary Vehicle-Fleet Modernization Program VVMP popularly known as India’s Scrappage Policy, 2021 is aimed at creating an eco-system for phasing out of unfit and polluting vehicles. The policy was introduced by Prime Minister Narendra Modi, at
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The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH, 2018) is an EU regulation created to protect human health and the environment from the risks posed by chemicals. REACH applies to substances on the nanoscale according t
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Who is affected?  Pesticide manufacturers engage in the manufacture, processing, and repackaging of pesticides, and importers of pesticides in Taiwan need to comply with the Pesticide Management Act and apply for licenses.    Timeline  Pesti
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The validity period of the pesticida License is five years. Within 6 months before the expiry date, the concerned individual may apply for an extension to the central competent authority; each extension shall not exceed 5 years. The application for
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The pesticide regulation in China is called Measures for the Administration of Pesticide Registration. The Measures came into force from the promulgation of the decree of the Ministry of Agriculture and Rural Affairs (MARA) on Aug. 1, 2017. The temp
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The name of the pesticide should use the Chinese generic name of the pesticide or the simplified Chinese generic name, and the name of the botanical pesticide can be represented by the plant name plus the extract. The name of the directly used sanita
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Pesticide manufacturers, companies exporting pesticides to China, or developers of new pesticides will need to apply for pesticide Registration in China, depending on their roles there are different requirements apply. Domestic applicants apply for
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The applicant shall submit the product chemistry, toxicology, efficacy, residues, environmental impact and other test reports, risk assessment reports, labels or instruction sheets, product safety data sheets, relevant documents, application forms, a
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MARA or the provincial agricultural and rural department shall deal with the application materials submitted by the applicant according to the respective following circumstances: no pesticide Registration is required: immediately inform the applic
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Review and decision will take at least 11 months.  The provincial agriculture and rural departments shall, within 20 working days from the date of accepting the application, conduct a preliminary examination of the materials submitted by the applic
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The extension of license will take at least 10 month. If it is still necessary to continue to produce pesticides or export pesticides to China after the expiration of the validity period, an application for renewal shall be made 90 days before the
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Provincial agricultural and rural departments should report monitoring and evaluation results to MARA in a timely manner. The holder of the pesticide Registration permit shall collect and analyze the safety and effectiveness changes of pesticide p
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New Chemical Substances (refers to those not listed in the inventory) can be registered in three types under the TCCSCA: Standard Registration: at 1 ton or more Simplified Registration: at 100 kilograms or more, but less than 1 ton Small quanti
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India’s Chemicals (Management and Safety) Rules (ICMSR) also referred to as ‘India REACH’ will come into force on the date of their publication in the Official Gazette, expected mid-2021, and will regulate all substances, substances in mixtures
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Notification All manufacturers or importers (or authorised pepresentatives acting on behalf of foreign entities) shall notify National Chemical Authority of all existing Substances that they have Placed in Indian Territory in quantities greater t
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The United States has not yet ratified the Stockholm Convention. The main reason for the delay is that the United States does not have the authority to implement all the Convention’s provisions, and currently, the country participates as an observ
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China signed the Stockholm Convention on its launch in 2001 and ratified the Convention in 2004. Since then, the initial list of 12 POPs listed in the Stockholm Convention entered the government agenda. For example, the Regulation for Pesticide Manag
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Producers and importers of hazardous substances and mixtures to the Norwegian market have to follow the Regulations on declaration of chemicals to the product register (declaration regulations), enforced on June 1, 2015. Applicants need to submit in
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Businesses producing or importing 100 kg or more of a chemical substance are to declare their products, where the Registration must take place by the latest when manufacture, market placement, or professional use begins in Norway.    Aside from t
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As an importer having a detailed profile of chemicals entering the Norwegian market, a declaration of chemicals applies.   However, as for individual business who does not wish to disclose such Confidential Business Information (CBI) as mixture co
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India’s Chemicals (Management and Safety) Rules (ICMSR) also referred to as ‘India REACH’ will come into force on the date of their publication in the Official Gazette, expected mid-2021, and will regulate all substances, substances in mixtures
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The main chemical regulation in Turkey is KKDIK, which is an acronym in the Turkish language for Registration, Evaluation, Authorization and Restriction of Chemicals. KKDIK is also known as Turkey-REACH. Kimyasalların  (Chemicals) Kaydı
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Under Turkey-REACH, chemicals can be registered with following tonnage bands: 1-10 tons/ year 10-100 tons/ year 100-1000 tons/ year 1000+ tons/ year In case the substance qualifies as an intermediate, the applicable tonnage bands
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The following substances are exempted from Turkey REACH:  Radioactive substances and mixtures Substances, on their own, in a mixture or in an article, which are subject to customs supervision, provided that they do not undergo any treatmen
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The deadline for Pre-Registration under the KKDIK is 31 December 2020. Substance Registration will start from 1 January 2021 and end in 31 December 2023. Companies that submit the pre-Registration before 31 December 2020 can co
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Turkish Manufacturers Turkish Importers Non-Turkish manufacturers can appoint an “Only Representative (OR)” to register on behalf of them, also taking over the Registration responsibility from the importer.
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Companies can pre-register the substances by filling the pre-SIEF. 
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Documents   1 – 10 t/y  10-100 t/y  100-1000 t/y  1000 + t/y  Technical Dossier including main information as registrant’s identification, Substa
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Registrants can submit pre-Registration and Registration via MoEU Chemical Registration System (KKS): https://ecbs.cevre.gov.tr/ 
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Non-Turkish companies that exporting substances to Turkey are not obliged to register unless they appoint an "Only Representative"(OR) to accomplish the obligations of importers. 
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Enterprises need to do TII Registration if their registered chemicals are considered as intermediates. Buyers have to provide a declaration regarding the use of the chemical, often under strictly controlled conditions. Registrants can do self-decla
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Substances actively used in biocidal products are regarded as already registered, as biocidal products and their active ingredients are covered by Biocidal Products Directive. However, several conditions have to be fulfilled to benefit from the
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According to Article 36 of the Measures for the Environmental Management of New Chemical Substances (MEP Order 7), companies that have acquired the Registration certificate of China New Chemical Substance Notification have the obligation to submit an
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The exact details of UK REACH Registrations will be known once UK REACH comes into force and the UK REACH-IT opens after 31st December 2020. More information will be updated here during the last quarter of 2020.
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Existing EU REACH Registrations held by UK-based companies and those including only representatives will automatically be ‘transferred’ and will become UK REACH Registrations. This means that qualifying registrants will not have to re-register
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There is no specific deadline for Phase One Registration. According to the revised regulation in 2019, manufacturers/importers who manufacture/import Existing Chemical Substance in an annual amount of 100 kilograms or more, should apply for the Phase
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The Registration fee is listed below:   Type of Substances Category  Fee  Existing Chemical Substance   Phase One Registration   100 NTD (app.
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The list can be found on the Appendix 6 of the Regulations of New and Existing Chemical Substances Registration or GPC Taiwan website.
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See Word Document.
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Companies can share the cost for standard Registration, depending on their own agreement.
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Companies do not need to register mixture. However, individual chemical substance in the mixture need to be registered.
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Yes, Turkey-REACH applies to substances occurring in nature, as defined by Article 4(h) of Turkey REACH. However, Annex V of Turkey REACH states that the following substances occurring in nature are exempted from Registration if they are not chemi
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According to Article 7 of Turkey REACH, polymers do not have to be registered, but the monomer substance(s) and other substances of the polymers that have not been registered by an actors within the supply chain, can be registered with followin
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The term "polymer" under K-REACH refers to chemical substances satisfying all the following requirements. It shall be composed of molecules in which at least one kind of monomer unit is continuously repeated; It shall represent the characteri
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According to the K-REACH Article 10, those who intend to manufacture or import more than one ton per year need to register substance. After pre-Registration, companies can get a grace period that allows manufacturer and importer to continue their bus
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According to the K-REACH Article 10, a person who intends to manufacture and import a existing chemical substance more than one ton per year needs to register before manufacture or import. To get the grace period, the pre-Registration is required. Ho
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No, pre-Registration is necessary if a person has manufactured and imported the existing substance for more than 1 ton per year in 2016, 2017 and 2018. While proceeding the pre-Registration, the person can continue to manufacture and import the conc
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Those who intend to manufacture and import existing chemical substances more than one ton per year may be subject to the grace period after the pre-Registration deadline (2019.6.30) once completing the late pre-Registration. However, in order to fac
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New chemical substances are not subject to pre-Registration. During the grace period, one must report (less than 100kg per year) or register (more than 100kg per year) before manufacture and import.
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When there changes after the Registration is completed, a company must report the changes by submitting a change Registration application. Change Registration Change report The cases and its dea
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The procedure of co-Registration for a company who wants to register its chemical substance is as follows: 1) Join a chemical substance information communicative organization (CICO) 2) Select a representative of the CICO 3) Sign an agreement
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The late registrant is subject to the co-Registration as well. Therefore, a company needs to sign in the CICO and pays for the dossier that the CICO already has prepared and submitted to the authority. The contact information of the CICO representati
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Each individual chemical substance in a compound needs to be registered. For instance, if your company imports 1,000 tons of a compound containing 3% of a chemical substance A, then you are obliged to register the chemical A as it is over 1 ton (1,00
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Companies are allowed to manufacture or import after receiving Registration confirmation letter from the MoE, which is issued 30 days after the submission of all the required dossier. During the grace period, companies can manufacture or import the c
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No, a company can start importing after receiving Registration confirmation letter, which is issued 30 days after the application. However, if it is designated as a toxic substance after risk assessment, the company needs to comply with the handlin
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The new substances should be notified before placing into the market by Swiss manufacturer, Importer Only Representative can notify the substances on behalf of Non Swiss Manufacturer
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The Substances and preparations that are hazardous or PBT/vPvB or on Swiss SVHC candidate list;even if quantity is
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As per the Official Guideline on Registration Heading 2.5.1 in KKDIK, the ingredients in the finished cosmetic products also need to be registered, as cosmetic products can be defined under the term "mixture" and ingredients of a mixture must be regi
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According to KKDIK Article 47, a substance is considered SVHC (substances of very high concern) if it is classified as: CMR categories 1A or 1B according to Turkish CLP Regulation PBT (Persistent, Bioaccumulative or Toxic) /vPvB (very Persist
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Substances that are considered as SVHC need to be notified to the ministry if they make up more than 1 ton per annum and 0.1 w% of the main substance/article. Upon request from a user, sufficient information allowing safe use of the substance (Safety
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The deadline set by the HSE for DUIN notification is 27 Oct 2021. If this deadline is missed, the Non-GB manufacturers will not be able to place the chemical into the GB market. In such case, they will have to first register the chemical by the New
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Yes, UK importers can fullfil the requirements of DUIN notification on behalf of the non-GB exporter. 
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Mixtures are exempted from Registration in UK REACH.  DUIN possibility lies only with the individual substances and those entities who have registered in EU REACH.  The manufacturers of the mixtures will have to depend on the entities wh
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From 1st January 2021, EU REACH and UK REACH are operating independently of each other. For the chemicals that will be placed for the first time in EU and GB market, compliance to the respective regulations will therefore be needed. For ne
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DUIN notifications will only be possible for those chemicals that are already registered in the EU. If a new chemical is to be placed in the GB market, obligations of new Registrations would be applicable.  
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Substances not registered within EU REACH will be treated as new substances and before placing these new chemicals in the GB market, they will have to be registered through the Inquiry route in UK REACH. 
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If the GB based buyer uses his/her UK REACH Registration, then the suppliers do not need to perform Registrations from their end. The only disadvantage in this case would be that since the GB based buyer holds the UK REACH number, they can opt for
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HSE will not incur any fees for DUIN notification. However, OR service charges would be appliable. 
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The deadline for DUIN is 27th Oct 2021 (300 days from 1st January 2021). DUIN has to be completed before placing the chemicals in the GB market. 
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The exemptions of UK REACH and EU REACH are the same.  
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