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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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In 2017, the Council of the Eurasian Economic Commission (EAEU Commission including Russia, Belarus, Kazakhstan, Kyrgyzstan & Armenia) adopted the Technical regulation 041/2017 ‘on safety of chemical products’ .
This Regulation i
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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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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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The additions include three substances that are toxic to reproduction and one endocrine disruptor. The Candidate List of substances of very high concern (SVHCs) now contains 209 substances that may have serious effects on people or the environment.
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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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ECHA has announced new obligations for the Mixtures being placed into the EU market. For every Mixture placed on the market, a new notification i.e., Poison Centre Notification (PCN) w
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In a recent personal communication with CIS Centre, Russia got notified that, due to the COVID-19 crisis, the Russian Inventory Notification Deadline due on May 1st, 2020 has been extended 3 more months to August 1st, 2020.
Below is the full e
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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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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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The “Occupational Safety and Health Act” was revised on January 15, 2019 and came into effect from January 16, 2020. In relation to this Act, the “Material Safety Data Sheet” (MSDS) was recently revised and will be effective from January
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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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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
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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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Colombia incorporated GHS guidelines in 2018 based on the Decreto 1.496/2018. The regulation provides guidance for ministries to implement the standard in each sector. In 2021, the Ministry of Labor is the first sector to adopt GHS under Resol
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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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In EMB Memorandum Circular No. 2021-08, the Department of Environment and Natural Resources (DENR) – Environmental Management Bureau (EMB) issued the 2021 updated Philippine Inventory of Chemicals and Chemical Substances (PICCS). 52 new chemica
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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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On July 9th, ECAH added eight chemicals to the Candidate List of SVHC, expanding the list from 211 to 219 entries. These newly added substances are used in consumer products such as cosmetics, scented articles, rubber, textiles, or as solvents an
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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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On 31st August 2021, the United Kingdom’s Health and Safety Executive (HSE), in charge of implementing UK REACH, published a draft recommendation for the inclusion of two substances into the Authorization List: Dicyclohexyl phthalate (CAS
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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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Chile drafts a new regulation to further promote safe products among the ones used by children. These products will have to comply with the provisions established by the regulation and present the certificate attesting conformity in order to be
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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 Candidate List of Substances of Very High Concern (SVHC) now contains 223 entries. On 17th January 2022, ECHA added four hazardous chemicals that are commonly used in cosmetics to the candidate list.
Under the REACH regulation, companies have
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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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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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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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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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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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Consultation on the proposed amendments to the Vietnamese rules on their restricted chemical licences, labelling, management logbooks, and annual reporting deadlines is currently ongoing until June 26, 2022. The approved changes would accordingly be
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Recently, the opinions of the Committee for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) were made available publicly on the ECHA website for undecafluorohexanoic acid (PFHxA). An initial proposal was made by Germany to set restrictions f
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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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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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India holds a public consultation on a draft standard for carbon tetrachloride, which is widely used as a solvent and diluent. The deadline is June 28.
The chemical is also used to make chlorofluoromethane refrigerants, as well as grain fumigants,
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Australia implemented GHS for workplace hazardous chemicals (both substances and Mixtures) from 1 Jan 2017. There is no separate guidance on chemical Classification in Australia. It is recommended to use 3rd revised version of GHS for classifying th
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Canadian chemical substance list includes two parts: the Domestic Substance List (DSL), which records more than 23000 substances, and Non-Domestic Substance List (NDSL) which records almost 58000 substances.
DSL is used to identi
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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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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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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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Regulation (EC) 1223/2009
Scope
Regulation (EC) 1223/2009 on cosmetic products covers cosmetics defined as:
Any substance or Mixture,
Intended to be placed in contact with
The external parts of the human body (epidermis, hair system, nails, lips and external genital
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At present, there are multiple Act/Rules in India governing the chemicals industry that fall under the purview of different Ministries/Departments. An illustrative list for reference is given below:
FUTURE FOCUS AREAS :
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PRTR notification requires two parts of information: amount of release and amount of transfer:
Amount of release: Release into atmosphere, release into public bodies of water, release into soil within the place, and reclamation w
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Scope of K-REACH
Within Scope
Substance on its own – New Substances(1) and Existing Substances
Substance in a Mixture
Product(2) containing priority control substance
Out of Scope
Naturally occurring substan
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Compliance requirements
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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General information about the Eurasian inventory
A common Eurasian inventory for chemical substances and Mixtures is expected to be formed as a part of the decision taken by the Eurasian Economic Union Comission (EAEU Comission) on the formation of the TR 041.
There are two major steps that ar
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The Russian inventory
The Russian inventory of chemicals and Mixtures has been established as a first step in the formation of a common Eurasian inventory (thus the Russian inventory is a part of the Eurasian Inventory!)
The main aim of the inventory is to aquire inf
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Exemptions
The Regulations shall not apply to any of the following substances or articles:
Substances which occur in
Chemical substances in machines or equipment for test run
Inseparable intermediates from chemical reactions in the reaction vessel or produ
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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. The regulation came into force immediately on 19th Feb 2015.
Manufacturers a
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Thailand Existing Chemicals Inventory (TECI) is the national inventory that contains chemical substances imported and produced in Thailand. The development of TECI is part of a project listed under the 4th National Strategic Plan on Chemical Manageme
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Aim
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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Only representatives have to be :
A natural person or legal entity established physically in TURKEY
Equipped with sufficient knowledge in the practical handling of the substances and information rel
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Regulation
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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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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Obligations for non-Indian (Foreign) Companies
A Foreign manufacturer who wishes to place a Substance, Mixture or Article in Indian Territory may appoint an Authorized Representative to ensure compliance with these Rules and this Authorized Representative shall be liable for the discharge of a
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Obligations of Downstreem Users:
Downstream users shall ensure that substances and Mixtures are notified and registered “in accordance with these Rules.”
In addition, downstream users are obligated to review uses that are part of the notified and/or registered substances. If
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Toxic Substances Control Act (TSCA) Summary
The Toxic Substances Control Act of 1976 provides EPA with authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or Mixtures. Certain substances are generally excluded from TSCA,
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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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Background
Under Annex VIII to the CLP Regulation, importers and downstream users placing hazardous Mixtures on the EU market are to provide specific information on their Mixtures to appointed bodies. The annex also specifies a harmonised format for notificatio
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Main requirements of K-BPR
1. Consumer chemical product
Ministry of Environment (MoE) designated consumer chemical products that have a potential to expose hazardous chemicals to human and environments while its use at the home, office, and public facilities (“consumer chem
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Scope of K-BPR
Within scope
Consumer chemical product (1)
Biocidal substance (2)
Biocidal product (3)
Biocidal treated product (4)
Out of scope
Consumer chemical products and biocidal chemicals used for
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Notifying to SCIP database
From 5 January 2021, article information should be communicated. To successfully notify your article to the SCIP database there are several categories for which information needs to be provided:
Category 1: Information on Article.
In
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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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Scope of the MSDS
Substances subject to prepare MSDS: a chemical substance or Mixture that causes health disorders to employees
Exception:
a chemical substance or Mixture that is specified in 15 other Acts.
a chemical substance or Mixture provided mainly to
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After the submission for the Registration
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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Timeline
For all ‘new’ products not already notified under national legislation, you must submit the required information before you place the Mixture on the market. Submissions should be made in the harmonised format, according to the relevant date of ap
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Who can submit the information?
Legal entities on behalf of duty holders, such as consultant, mother company, i.e. ‘Foreign user’
Importers or downstream users of Mixtures out of scope i.e. a voluntary submission
Legal representative of non-EU suppliers can also
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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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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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Conditions / criteria within which a product should not be placed on the market
The biggest going with obstacles were lacking products with correct markings.
(1) No checked research center Mixtures have been related to added substances.
(2) Other Mixtures will be applied without authorization, including profoun
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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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Role of Registrant
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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Overview
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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Overview
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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Labelling Requirements
Apart from the points discussed above there are some specific points/things that need to be present while the labelling of the article
Name of the Food
Specific List of Ingredients
Stated as the descending order of the composition of that par
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Labelling
Different categories can be assigned to a material based on its size or shape. When reviewing available information for categorization purposes, one must evaluate the forms or physical states in which the chemical or Mixture is placed on the market a
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India's Chemicals (Management & Safety) Rules - DRAFT
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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Legal Basis and Authority
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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Declaration
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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Transmission for CLP Annex VIII
For importers and downstream users placing Mixtures on the market not notified under national legislation have to comply with the requirements in CLP Annex VIII from the following dates:
Mixtures for consumer use and Mixtures for professiona
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Confidential Business Information
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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Background information
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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EU Poison Centers Notification (PCN) : Key information to companies placing hazardous Mixtures on the EEA market
A new label element will appear on product labels from 2021 – a 16-character code called the unique formula identifier (UFI). By 2025, the UFI will be mandatory on the label of all products classified for health or physical hazards. Importers and d
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When to Submit PCN?
Importers and downstream users placing hazardous Mixtures on the market not notified already under national legislation must comply with the new PCN requirements from the following dates:
Mixture for consumer use: 1 Jan 2021
Mixture for profess
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Which information do I need to submit?
The following information needs to be submitted.
Identification of Mixture and submitter.
Hazard identification and additional information.
Information on Mixture components
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As a supplier, how can I avoid disclosing the composition of my Mixture to my customer who uses it as a co-formulant in their product?
You can avoid disclosing the composition of your Mixture to your customer by providing the UFI. Your downstream users will include that UFI in the notification of their products.
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Do I need to relabel all my Mixtures (for adding the UFI) before 1 January 2020?
You do not need to relabel your Mixtures if they were notified under national schemes as the notification remains valid until 1 January 2025, unless you need to make an update. When you are required to submit information according to Annex VIII (i.e.
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If our company is producing Mixtures, what information should be submitted?
For Mixtures it is necessary to take into account all components presented in their composition in a concentration of more than 0.1% (by weight). We recommend including substances that are presented in a concentration of less than 0.1%, in cas
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What Mixtures are in scope?
You need to submit information on Mixtures classified for any health or physical hazard and falling under the scope of the CLP Regulation. Therefore, the obligations do not apply to substances. You also do not need to make a submission for Mixtures i
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What about non-hazardous Mixtures which are subject to supplemental labelling requirements?
Note that Mixtures which are subject to supplemental labelling requirements according to Part 1 and 2 of Annex II to CLP (e.g. EUH208) but are not themselves classified for health or physical hazards, are not subject to submission requirements and do
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Are aqueous solutions of substances in scope of Articles 45 of CLP?
Yes, substances in solutions are in the scope of Article 45 of the CLP Regulation. By definition, a solution composed of two or more substances is a Mixture, see CLP Article 2(8). This includes certain diluted acids and bases which may be listed with
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How long is a company liable for a notification?
The information must always be up to date for Mixtures as long as they are placed on the market. If the product is no longer placed on the market, the company is not required to update the information.
Note that is no “expiration date” of a noti
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How can EU based importer obtain information on the composition of Mixtures if he is importing, if the non-EU supplier does not want to disclose it?
It can be difficult to obtain information on the composition of a Mixture from a non-EU supplier. However, under both CLP and REACH, importers need to have information on the composition of the Mixtures being imported in order to be able to comply wi
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As a supplier, how can I avoid disclosing the composition of my Mixture to my customer who uses it as a co-formulant in their product?
You can avoid disclosing the composition of your Mixture to your customer by providing the UFI. Your downstream users will include that UFI in the notification of their products.
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How do I declare the components of the MiM in my final Mixture?
You have three possibilities. If you know all the components of the MiM, you need to list them like you would do with the other substance components of your Mixture. If you do not know all the components of the MiM, you can use the UFI of the MiM tog
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I am formulating a Mixture using a non-hazardous Mixture from another supplier. How do I get the compositional information on this Mixture (my MiM) for my submission?
Establishing good communication in the supply chain is a key factor. You can either request the compositional information from your supplier, or if they have made a voluntary submission, they can also provide you with a UFI instead. In any case, you
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