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An EU-wide Forum enforcement project has found significant non-compliance in the Classification and labelling of mixtures.
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The 2020 Chemical Data Reporting (CDR) submission period begins on June 1, 2020 and runs through November 30, 2020. The CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Inventory to report data o
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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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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 and the EU have ruled out the possibility to extend the transition period beyo
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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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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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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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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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Australia announced in the beginning of year 2020 about their decision to adapt 7th Revision of the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) from 1st July 2020. This will be adopted under the Model Work Health
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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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On June 24th 2020 the National Institute of Metrology, Quality and Technology (Instituto Nacional de Metrologia, Qualidade e Tecnologia – INMETRO) published Directive 217/2020and this Directive is intended to revise two other Directives, and amends
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Some chemicals are source of increasing concern as they can cause allergic reactions after skin contact. In view of the likely exposure to sensitising chemicals found in textiles, leather, hide and fur articles, the Swedish Chemicals Agency (K
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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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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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On 22 Dec. 2020, the General Administration of Customs has released an announcement on the inspection of hazardous chemicals subject to import and export. According to the Regulations on the Safety of Hazardous Chemicals (Decree No. 591 of the
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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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The Eurasian Economic Commission has published an updated draft of the 2nd tier of Eurasian Technical Regulation TR 041/2017 on “Safety of Chemical Products” (Eurasia REACH). The draft is available for public discussion until the 1st of April 202
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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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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. The Decree 57 was promulgated in November 2019 and communicated
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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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Last year, ECHA continued addressing groups of structurally similar substances instead of assessing each chemical individually. This group approach boosted the total number of chemicals assessed in 2020 to around 1 900 – which is twice as many
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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 Government of Canada evaluated the risks of PFOS, PFOA, and LC-PFCAs, and published the findings in screening assessment reports in 2006 and 2012. The PFOS, PFOA, and LC-PFCAs (and their salts and precursors) are prohibited through regulations
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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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In August 2020, the 5th draft of the Chemicals Management & Safety Rules (CMS Rules) was published by the Government of India. These draft rules are based on the EU REACH legislation and the existing Manufacture, Storage and Import of Hazardous C
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Philippines-Environmental Management Bureau (EMB) informs the Bureau of Customs (BOC) on the upcoming implementation of GHS in chemical mixtures and seeks their cooperation for enforcement
Early February, the director of The Department of Envi
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The National Institute of Environmental Research (NIER) in South Korea updated the chemical substance Classification and labelling list on July 12th, 2021. This list includes name of chemical substances, unique number, CAS number, hazard code, la
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On the 22nd of July 2021, the US House of Representatives passed H.R. 2467, the PFAS Action Act of 2021. This is a comprehensive framework for regulating 9,252 per-and polyfluoroalkyl substances (PFAS). Unlike a similar bill (H.R. 535) which was
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Through the Ministry of Employment and Labour under the Occupational Health and Safety Act, 1993, on 29 March 2021, the government of South Africa finally published its regulations concerning Hazardous Chemical Agents. This is a supersession of the c
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As per section 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of Lotus corniculatus extract. This substance was identified as a
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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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National Institute of Environmental Research (NIER) in South Korea published a guide to the Classification of biocidal product types on Aug 18th, 2021. This is to help industry to examine different types of biocidal products under K-BPR.
There are
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Certain amendments were proposed to the 8th version of GHS at the 10th session of the "Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labelling of Chemicals" held on the 11th of De
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As published on the website of the official gazette, the Turkey cosmetic regulations’ annexes were amended in September. The parts that were amended include:
Annex 2 (List of forbidden substances)Annex 3 (List of substances that cosmetic prod
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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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In October 2021, US EPA removed the confidentiality status for 377 substances, making their chemical status available to the public. According to the TSCA inventory, these chemicals make up about 8,000 of the 42,000 chemicals listed there.
In Apri
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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 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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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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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 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 July 9, 2021, the General
Department of Chemicals of the Ministry of Industry and Trade (MOIT) of Vietnam
published a
draft decree to amend Decree No. 113/2017/ND-CP
regarding the Law on Chemicals.This amendment includes the
addition of regul
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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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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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In February 2022, the Brazilian Health
Regulatory Agency (ANVISA) submitted a proposal for including
substances/organisms as active ingredients into authorized monographs authorized
in Brazil. The proposal IS open for public consultation for 60 da
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On March
11, 2022, the commission announces its decision of a biocidal product in line
with Regulation (EU) No 528/2012 of the European Parliament and of the Council.
A product that contains capsicum oleoresin expeller pressed to be used as a
rep
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On February 28, 2022, the Secretariat of
Infrastructure, Communications and Transportation (SCT) issued an Official
Mexican Norm (NOM in Spanish). This regulation assigns specifications for transporting
certain classes of dangerous goods, includin
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On February 24, 2022, the Latin America and
the Caribbean Circular Economy Coalition launched a document envisioning a
stronger Circular Economy vision for the region. It intends to inspire
governments, stakeholders, and initiatives towards a comm
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The Canadian government has posted draft
screening assessments for a batch of 34 chemical compounds, inclusive of lithium-
and barium-containing substances. The government recommends that they pose a
"low chance of damage to the env
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The National Institute of Environmental Research (NIER) in South Korea updated the regulation on the scope and methods of biocidal substances and biocidal product approval application data under the Consumer Chemical Products and Biocides Safety Cont
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In Brazil, the Globally Harmonized System (GHS) of Classification and labeling is established by the Brazilian National Standards Organization (ABNT) standard and officially implemented by Regulatory Norm (NR) 26. Currently, chemical Classification a
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Colombia officially joined the Organisation for Economic Co-operation and Development (OECD) in April 2020 despite not complying with all instruments required by the organization at the time. In this respect, Colombia has been working to develop post
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Peru has been working on its national chemical policy at least since 2020. In recent months, Peru approached the United Nations Environment Programme (UNEP) for funding its implementation and enforcing mechanisms.
UNEP has been holding a special C
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The Ministry of Food and Drug Safety (MFDS) in South Korea updated the regulation on precautions when using cosmetics and labeling of allergens under Cosmetic Act on April 27th, 2022. This is due to the update of the enforcement rule of the Cosmetic
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A new version of the Japanese online tool, Globally Harmonized System (GHS) Mixture Classification and Labelling Creation System (Nite-Gmiccs) from the National Institute of Technology and Evaluation (NITE) has been released.
The latest ver
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The Occupational Safety and Health Administration, Ministry of Labor of Taiwan released a question-and-answer format of the SDS checklist on April 21, 2022. This is to encourage the downstream users and companies of chemicals to verify the contents o
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The European Chemicals Agency (ECHA) and the European Food and Safety Authority (EFSA) announced on May 10, 2022, that an ongoing assessment of the health and environmental risks of glyphosate will be delayed. Glyphosate-based herbicides are the most
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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 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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The Chilean Ministry of Environment published on May 10, 2022, Resolution 240/2022 to better identify products that fall under packing materials and further indicate the corresponding categories. The provision is aligned with the Decree 12/2020 that
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Latin American countries have been constantly improving their chemical management instruments in the last few years. Among several meetings and discussions, countries are motivated to pursue the implementation of their national chemical policy.
Th
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India has launched a consultation to update standards for titanium (rutile grade) and barium sulphate pigments, both of which are used in paints and varnishes. The draft amended standards, which were published on April 27 by the Bureau of Indian Stan
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According to the EU Commission, the EU executive is sketching an alternative to add the endocrine-disrupting chemical Resorcinol to the REACH candidate list. It had been consensually approved earlier in February with industry and member states, subsi
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South Africa opened a consultation until April 29, 2022, to consult on the migration limits for 19 substances used in toy production. This new draft standard is aimed at upgrading South Africa’s toy regulations to sync with the EU’s latest regula
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The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘Designation of existing biocidal substances subject to approval deferment’ under the Consumer Chemical Products and Biocides Safety Control A
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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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Consolidated versions of UK REACH and Classification, Labelling and Packaging (CLP) legislation were published, including the incorporation of amendments made to EU regulations covering post-Brexit national laws. The concern about the effectiveness b
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According to ECHA, France submitted a new Harmonised Classification and Labelling (CLH) registry proposal of fluoroethylene (EC 200-832-6, CAS 75-02-5) in May 2022. The dossier to this intention registry has been submitted and it is under accordance
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Japanese standards on chemical Classification, labelling and safety data sheets (SDSs), JIS Z 7252 and JIS Z 7253, have been aligned with the Globally Harmonized System (GHS) Rev.6.Until May, 24, 2022, chemical suppliers were given the time to arrang
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The International Council of Chemical Associations (ICCA) has announced a new four-year pilot project between four African countries. These four African countries, Cote d’Ivoire, Ghana, Kenya, and Nigeria collaborated to start a project that will
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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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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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From June 1-3, 2022, the Latin America Regulatory Cooperation Forum (LARCF) hosted a two-day event to exchange information and progress toward sound management of chemicals across the region. LARCF has been front running with events and cooperation p
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The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) consults on its opinion regarding the safety of titanium dioxide in toys until July 4, 2022.
Considering the Classification of titanium dioxide i
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GHS – Classification
Regulation (EC) No 1272/2008 states that it applies to all substances and mixtures supplied in the European Community except where other community legislation “lays down more specific rules on classification and labelling”. The labelling of c
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Main Requirements of K-REACH
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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K-REACH Pre-registration
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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K-REACH registration
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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Joint submission of existing substance registration
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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Exemption list of TR 041 (Appendix 1)
1. Chemical products intended for scientific research work.
2. Minerals in a state of occurrence, as well as the following products, if they have not been chemically modified: minerals, ores, ore concentrates, cement clinker, natural gas, liquefie
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Exemptions from the Russian inventory
Please note!
Chemicals that are subject to another technical regulation are nominated voluntarily
Informatio
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Registration for Existing chemicals
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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Latest from Brexit!
The UK has formally left the EU at 23:00 GMT on 31st January 2020 with a Withdrawal deal.
This has only marked the next step in the Brexit process. Post-Brexit, the UK has now entered a transition period until 31st December 2020 (also known as the
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ICMS Rules at a glance:
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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Claim of Confedentiality - CBI - within ICMS Rules
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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Classification and Labelling Criteria within ICMS Rules
India proposes that Classification, labeling, and SDS align with the United Nations Eighth Revised Edition (Rev 8) of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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Information to be provided for Notification
Following information shall be submitted to the Division for Notification of Substances. This information must be based on test reports from NABL accredited labs or GLP labs or any other Published Authentic study reports.
Name of Notifier
Chemica
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National Inventory of Chemical Substances
The article 6 and 7 of the draft law requires that producers or importers of industrial chemical substances, including substances in mixtures, in an amount equal to or greater than 1 ton per year (based on three years' average), submit the follow
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GHS-Classification:
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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Requirements for Hazardous substance or preparations
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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Registrant's rights and obligations
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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System of environmental management and registration of new chemical substances.
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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Technical regulation section
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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KOSHA (Occupational Safety and Health Act): MSDS regulation
A person who intends to manufacture or import any chemical substance or a mixture, which falls under the Classification standards for hazards and dangers of chemical substances, physical factors, etc. that cause health impairments to employees, shall
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Brazil Pesticide Regulation
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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Legal Basis
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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Data Requirement
Notifier's Details
Substance Identifiers
Impurities
Hazard Classification
Uses
Tonnage
SDS
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Labelling
The Department of Agriculture, Forestry, and Fisheries (DAFF) is responsible for ensuring that pesticides are appropriately labelled and that all information necessary for safe use is prominently displayed. Information should be given in such a way
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How can GPC help you?
Guidance on PCN requirements
Assess the portfolio to identify the
Notification Requirements
Trade names and Brand
Country specific variations
Use specific variations
Components specific variations
Possi
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Fee Structure
Serial No.
Application Type
Standard Fee
Small Business Fee
01.
510(k)
$11,594
$2,899
02.
PMA, PDP, PMR, BLA
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Chemicals Strategy for Sustainability
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
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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Product Registration
Before placing a device, other than a custom-made device, on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 27(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and
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Classification, Labelling and Packaging (CLP Regulation)
CLP regulation came into force on 20 January 2009. It gives harmonized requirements for the Classification, packaging and labelling of the articles and chemical substances. CLP regulation is based on the United Nations’ Globally Harmonized System (
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Labelling requirements
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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Labelling Requirements
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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Legal Basis and Authorities
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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Risk assessment
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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Overview
A phytosanitary product must be registered in the National Register of Plant Therapeutics, either experimentally or commercially, in accordance with the provisions of Decree No 3489/58 and Decree No 5769/59, and in accordance with the Manual of Proce
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Circularity in Automobiles and EV
Existing Situation
Directive 2006/66/EC on batteries and accumulators (the Batteries Directive), last amended in 2018, is the current legal act in place for batteries. It applies to all types of batteries, irrespective of chemical composition, size
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Registration, Evaluation, Authorization and Restriction of Chemicals
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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List of Restricted Substances
The list of restricted/prohibited substances is listed in Schedule VI. Currently only one substance, phosgene, is restricted.
Priority substance is defined as:
Any Substance which falls under any of the following Hazard Classifications of the ei
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