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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 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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India is finalizing plans to increase the number of chemicals and petrochemicals to be covered by mandatory certification. The Ministry of Chemicals and Fertilisers, the responsible authority to issue list of products on which mandatory certification
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Safety of Toys has been brought under compulsory BIS Certification as per Toys ((Quality Control) Order from 1 September 2020. The order was notified to the WTO in February this year. For BIS Certification, toys have classified into two categories: (
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The Union Cabinet ratified ban on seven Persistent Organic Pollutants (POP) listed under Stockholm Convention. The Stockholm Convention is a global treaty to protect human health and environment from POPs, which are identified chemical substances
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GPC is delighted bringing to you our October Newsletter with a summary of toy regulatory updates around the world and other chemical compliance news.  Toys, both imported and locally manufactured, constitute a significant market for many cou
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The Central Government of India in exercising its powers conferred by section 16 of the Bureau of Indian Standards (BIS) Act (2016) prepared the following amendments in the orders that were published by the Ministry of Chemicals and Fertilizers,
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  On January 11, 2021, a stakeholder consultation meeting was organized by Additional Secretary (Chem) to discuss BIS standards of 12 chemicals. Nine of the twelve standards under consideration are concluded to be made mandatory. The 12 BIS s
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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 early April, the Department of Chemicals & Petrochemicals under the Ministry of Chemicals and Fertilizers, India chaired a meeting on implications of Poisons Act (1919) in chemical industry.   One of the issues that brought up in this
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On 27th May 2021, three new Quality Control Orders (QCOs) were published in the Gazette of India, namely:   The 3 (N, N Di-Ethyl) Aminophenol (Quality Control) Order, 2021  The Methylene Chloride (Dichloromethane) (Q
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India’s Ministry of Electronics and Information Technology (MeitY) published a draft policy paper Circular Economy in Electronics and Electrical Sector in May 2021. India is the third-largest consumer of raw materials produced globally. The
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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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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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Indian Government is proposing to bring out a ‘Reference Document for Carriage of Dangerous Goods by Road’. These Dangerous Goods (DG) refer to substances that pose risks to health, safety, property, and the environment when transported.  
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On the 17th of September 2021, India overturned its ban of recycled plastic in 2018, now allowing the use of recycled plastic in Food Contact Materials (FCMs). The exception to the new rule is that it doesn’t include chemical migration limits, that
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The Indian Department for Promotion of Industry and Internal Trade (DPIIT) amendment of the storage, handling, and packaging rules and stock reporting system for ammonium nitrate and calcium carbide came into effect on the 2nd of September, 2021.
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According to the Indian researchers who compiled the chemicals’ database, there is a need for better risk assessment and regulation of fragrance substances in children's products.  Due to the collaboration between two Research Institutes: t
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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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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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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 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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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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At the UN Environment Assembly that happened from 28th February to 2nd March, along with Japan, India has placed another proposal on the table which states an alternative resolution on single use plastics. It focuses on a voluntary framework rathe
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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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The Bureau of Indian Standards launch a consultation on a draught amended standard for terephthalic acid, which includes new standards, sampling techniques, and testing on February 23, 2022.The first edition of the standard was released in 2001.
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The Department of Chemicals & Petrochemicals on March 11, 2022, published its decision to extend the Quality Control Order implementation date for six chemical products. The new implementation date is September 13, 2022. The concerned chemica
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India started consultation on a draft international standard (IS) for sodium hypochlorite, also known as bleach. The item is described as an inorganic chemical widely used as bleach liquor. It is generally sold in aqueous solutions, according to
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The Indian Government proposes a new Draft National Policy for Medical Devices, 2022, to reduce India's reliance on high-end medical device imports. The government intends to adopt public-private partnerships to reduce healthcare costs, increase
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The Bureau of Indian Standards (BIS) has granted licences to 661 domestic toy manufacturers after determining that they comply with a 2020 quality control order that limits the use of certain heavy metals, phthalates, and flame retardants. Companies
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The Food Safety and Standards Authority of India (FSSAI) amended the Food Safety and Standards (Packaging) Regulations 2018, allowing for the use of recycled plastics in food contact materials (FCM) with certain restrictions. The update clarifies the
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As part of its drive to use safer alternatives, India has imposed restrictions on certain hydrofluorocarbons (HFCs) and ozone-depleting substances (ODSs), requiring importers and exporters to obtain government permission before trading. The new ru
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The Bureau of Indian Standards (BIS) is holding a consultation process until May 11 on a proposed amended standard for ready-mixed paint, air drying, and red oxide-zinc chrome priming, which would extend lead content limitations in place for domestic
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The Bureau of Indian Standards (BIS) is reinvestigating the use of eight chemical standards in plastics, resins, moulding, and extrusion materials. The standards cover:  Substance Comment Deadline
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On April 27, 2022, the Department of Chemicals and Petrochemicals of the Ministry of Chemicals and Fertilizers, India, published the Quality Control Orders (QCOs) in Gazette notifications for eight chemicals in order to make Bureau of Indian Standard
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On April 5, 2022, a Quality Control Order (QCO) for a national standard covering the intermediate trimethyl phosphite has been released in India. Published by the Bureau of Indian Standards (BIS), manufacturers and importers of the substance must gua
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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 the 13th of May 2022, the Central Government of India extended the enforcement date for three substances under the Quality Control Order (QCO). The Quality Control Order is the regulation that requires concerned substances/chemicals to carry t
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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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On the 27th of April 2022, India published a Quality Control Order (QCO) for a national standard encompassing the intermediate 1, 3 phenylenediamine. Manufacturers and importers of the substance must guarantee that it meets the standards given in Ind
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The Ministry of Environment, Forest and Climate Change (MoEFCC) and the Central Pollution Control Board (CPCB) have developed an integrated guidance framework for chemical safety in isolated storage and industries subject to the Manufacture, Storage,
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A draft standard was issued by the Bureau of Indian Standards (BIS) on May 6, 2022, for tooth whitening and bleaching products. The authorities invite comments till July 5, 2022.  The standard prescribes requirements and test methods for externa
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On May 20, 2022, the Indian Ministry of Environment, Forest, and Climate Change released a new regulation draft that will replace the current E-Waste (Management) Rules, 2016. In addition to information technology and telecommunications equipment and
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Page Industries, an Indian textiles firm, has established a restricted substances list (RSL) as part of its chemical management strategy, which will be enforced by enterprises throughout its supply chain. According to the corporation, it was publi
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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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Global Product Compliance is happy to announce that we will attend ChemExpo India which will be held on 20th to 21st of April, 2022. We will be present at the expo in booth C16 and look forward to meeting you and discuss your questions in person. Lo
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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 Indian Aspect The Food and Drug Administration in India is an autonomous body established under the Ministry of Health & Family Welfare, Government of India. There are two individual bodies in India that reg
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The Food Safety and Standards Authority of India (FSSAI) has been established under Food Safety and Standards, 2006 which consolidates various acts & orders that have hitherto handled food related issues in various Ministries and De
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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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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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For Renewal of License: Depends upon the number of years Modification of License: Fees of 1 year per licensemodification. Duplicate of License: 10% of the applicable license
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The chemical industry is an indispensable and integral constituent of the growing Indian  The wide range of chemical products play a vital role in catalyzing not only the economy of the country, but also making the li
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The Vision for the Indian Chemical Industry is : “To facilitate the accelerated growth and development of the chemical industry to meet local and global requirements, in an environment friendly manner, with focus on in
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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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India is currently the world’s 3rd largest consumer of polymers behind China and the US. India’s  polymerconsumption is 2 million tones which constitutes 3% of the global consumption.
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Indiais the 3rd largest producer of agrochemicals, globally and ranks 4th in terms of production of crop protection chemicals. The market for crop protection chemicals in India is expected to reach to USD7.5�
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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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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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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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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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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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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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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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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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Chemicals  Indian Standards  Title of Indian Standards  Date of Notification - WTO  Final date for comments  Reason / objective  Description  (1).�
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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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Drug and Cosmetics Act, 1940 Cosmetic is defined under section 3(aaa) of the Drugs and Cosmetics Act, 1940 as, any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any par
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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 Insecticides Act of 1968 and the Insecticides Rules of 1971 regulate the import, registration, manufacturing, sale, transportation, distribution, and use of insecticides (pesticides) in India, as well as other related matters. Before being made a
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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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In India medical device are governed by CDSCO (Central Drugs Standard Control Organization) which is regulated by Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
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In India medical device are governed by CDSCO (Central Drugs Standard Control Organization) which is regulated by Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. Many committees have been set up and
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India’s Central Drug Standard Control Organisation (CDSCO) has Central Licensing Authority (CLA) and State Licensing Authority (SLA) with responsibility for Licensing to Import, Manufacture for sale or for distribution and sale, stock, exhibit
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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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Determine if Product Requires Registration  Appoint an Authorized Indian Agent  Submit the Regulatory Dossier under Form 40  Obtain registration Certificate in Form 41  Obtain Import License in Form 10  Product Ma
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FCM
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Food Safety Standards Authority of India – FSSAI is responsible for designing science-based standards for articles of food and their regulation. India is one of the countries with non-specific/few regulations for Food Contact Materials. The
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Circular Economic aims to Reduce Waste by keeping the products in use, which signifies each product's importance. The circular economy seeks to make the most of the material resources available by applying three basic principles: reuse, reduce, a
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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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Because nanotechnology has so many different uses, experts have compiled a list of the top ten nanotechnology application areas that are of importance for developing nations like India in terms of achieving the UN Millennium Development Goals (MDGs).
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The Department of Science & Technology In the year 2000, the five government departments, namely the Defence Research and Development Organisation (DRDO), the Council of Scientific and Industrial Research (CSIR), the Department of Space 15 DOS, DS
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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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A Manufacturer, Importer or Downstream User shall ensure that all Priority Substances, Hazardous Chemicals and Mixtures containing more than 10% (w/w) of any Priority Substance or Hazardous Chemicals comply with labelling and packging requirements.
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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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This Newsletter covers key regulatory developments in China (MEE - Order 12); South Korea (Chemical Product Safety - KOSHA) and Upcoming Chemical Regulation in Brazil. Further it also highlights the upcoming deadlines and related obligations in relat
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