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Section 21 of the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) allows for the introduction of new chemicals into Australia provided the chemicals meet certain requirements stipulated in subsections 21(4) and 21(6) of the Act.
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We’ve been receiving enquiries about hand sanitiser Products, including in connection to the novel coronavirus (COVID-19).
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We've published a secondary notification for ethanol, 2-[2-(2-methoxyethoxy)ethoxy]-, 1,1',1''-triester with boric acid (H3BO3). This applies to all persons who manufacture or import the chemical and Products containing the chemical for use in brake
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In September 2020, the Ukrainian government published a draft resolution of changes to the Ukrainian Technical regulation on Toy’s safety. The changes in the Technical Regulation are prepared to bring the provisions of the Technical Regulation i
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The Chemical Product Safety Act, often known as K-BPR, enforced on 1st January 2019, regulates safety management of consumer Products and biocidal Products. The amendment of this Act was approved by South Korea’s Parliament and Cabinet on 4 March
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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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On March 11, 2019, Taiwan’s EPA published the amended regulation on New and Existing Chemical Substances, specifying Standard Registration for 106 existing chemical substances. From 1 January 2020, manufacturers or importers who manufacture or impo
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NICNAS  (National Industrial Chemicals Notification and Assessment Scheme) officially retires on 30 June 2020 and will be succeeded by the Australian Industrial Chemicals Introduction Scheme (AICIS) on 1 July 2020. On 1 July, NICNAS Business Ser
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The Ministry of Industry in Thailand published its new regulation B.E. 2558 on the notification of the Production and import of hazardous substances in Government gazette regarding Production and import of hazardous substances which come into force o
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Switzerland has adopted new disclosure obligations for some synthetic fibrous or tubular nanomaterials and intermediate chemical Products.
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We are delighted to announce that Sustainability Support Services (SSS) Europe AB has recently changed its registered name to Global Product Compliance (GPC)Europe AB as part of the recent acquisition by the Global Regulatory Compliance Holding. T
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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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South Korea’s Occupational Safety and Health Act (often called KOSHA) amendment on material safety data sheets (MSDSs) takes into force on 16 January 2021. Chemical manufacturers and importers shall prepare and submit an MSDS to the Ministry of Emp
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The first registration deadline under K-REACH is by 31 December 2021, which applies to those who manufacture and import existing chemical substances exceeding 1,000 tons per year, or carcinogenic, mutagenic, or reProductive toxins (CMR) at more than
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The Consumer Chemical Products and Biocide Safety Act amendment, often known as K-BPR, was promulgated on 24 March, and 26 May 2020 and will be enforced on 1 January 2021. The following section outlines a brief background of K-BPR and the significant
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My understanding from speaking with the Toxic and Chemical Substance Bureau is that the EPA’s plan to delay the Pecs deadline is partly due to the pandemic. But it is also because Taiwanese enterprises are still not familiar with standard registrat
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Previously, testing labs were all required to adhere to OECD guidelines or be ISO certified, but the guidance does not mention if universities and colleges need to follow those standards," said Chia-Sui Hsu from Global Product Compliance (GPC). See m
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In case of import, UFI can be used in the communication with a non-EU supplier. The following way can be considered to work around possible communication problems (e.g. if the non EU supplier intends to protect the confidentiality of the mixture info
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We are excited to share important news regarding the evolution of our company and if this change will affect any of your on-going or future activities with us. We are delighted to announce that our company has recently changed its registered name
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In the context of the COVID-19 pandemic, European states are encouraged to apply derogations to the normal Product authorisation requirements of the Biocidal Products Regulation (BPR)
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11th – 12th November, 2020 | Koelnmesse, Germany. Chemspec Europe, which is Europe’s major sourcing and networking event for fine and speciality
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The Substances of Concern In articles as such or complex objects (Products) also known as the SCIP database is a new requirement under t
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The Ministry of Environment pre-announced partial amendments of the two subordinate laws (the Enforcement Decree and the Enforcement Rules) of the Consumer Chemical Products and Biocides Safety Act (K-BPR) on 30 July 2020. The proposed date of adopti
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The Ministry of Environment and Urbanization of the Turkish Republic has published the draft of the price list for registration fees. It is known from the regulation from before that registration, updating registration, request on confidentiality,
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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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The Government of the Russian Federation has identified responsible institutions for implementing the Eurasian Technical Regulation 041 (TR 041), an official decree published on 16 September 2020. The Ministry of Industry and Trade of Ru
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The Thailand Cosmetic Regulation or Cosmetic Act B.E. was officially finalized in the year 1992. Thailand’s Ministry of Public Health has updated its lists of prohibited and restricted substances for use in cosmetic Products.  Many of the chan
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The Thai Ministry of Public Health launched a public survey to collect information on the Food Contact Materials (FCMs) currently on the market. According to Chemical Watch, the different types of materials survey covers are glass, ceramics, metal �
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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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With Brexit being implemented from 31st January 2020, the UK has formally left the EU with a withdrawal deal and it is currently into an 11-month transition period. The UK is no longer a member state of the EU and until the end of the transition p
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South Korea restricts the contents of Heavy metals, Phthalates, and Nitrosamines in children’s Products since 4 June 2020. As a result, manufacturer and importer of children’s Products should test Products to ensure not to exceed the maximum thre
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South Korean government published a list of 115 chemical substances where a simplified approval process is applicable. These 115 substances are active biocidal substances that were already approved under the EU BPR (Biocidal Product Regulation) and t
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Canada is one of the countries that take action on plastic waste and pollution. On October 10th 2020 the Canadian government plans to propose an order to add "plastic manufactured items" to Schedule One of the Canadian Environmental Protection Act (C
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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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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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The Turkish Toy Regulation has entered force on October 4th, 2016 and has been regulating the toy Products since then with the purpose of defining methods and foundations of security and free circulation of toys. The regulation was updated recentl
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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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Australia issued new legislation for toys containing magnets,” Consumer Goods (Toys Containing Magnets) Safety Standard 2020.” This new legislation will repeal the existing “Consumer Product Safety Standard for Children’s Toys Containing Magn
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On 14 September 2020, Denmark notified the WTO Committee on Technical Barriers to Trade of its enactment of an Executive order on safety requirement for toys. The purpose of the executive order is to transpose into Danish law Directive 2019/1922/UE m
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On 8 September 2020 the EU Commission notified the WTO Committee on TBT following the publication of a draft Directive amending Directive 2009/48/EC as regards specific limit values for aniline in toys. In Appendix C to Annex II to Directive 2009/
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On 17 March 2020 the EU Commission notified the WTO Committee on TBT following the publication of a draft Directive amending Directive 2009/48/EC in the following manner: In paragraph 1 of point 11 of Part III of Annex 2 of Directive 2009/48/EC
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On 17 March 2020 the Eu Commission notified the WTO Committee on TBT following the publication of a draft Directive amending Directive 2009/48/EC in the following manner: In paragraph 3 of point 11 of Part III of Annex 2 of Directive 2009/48/EC (l
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With Brexit being implemented from 31st January 2020, the UK has formally left the EU with a withdrawal deal and it is currently into an 11-month transition period. The UK is no longer a member state of the EU and until the end of the transition pe
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On October 14 the European Commission published the comprehensive Chemical strategy (EU Chemicals Strategy for Sustainability). The Strategy is the first step toward a zero pollution ambition outlined in the European Green Deal. The strategy covers
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Owing our experience and growth to the requests and guidance of our client base, we, Global Product Compliance have established our branch in Turkey on February 2020, as already known. Since then, we have been working hard to help our loyal client
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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 3rd 2020, Australian government announced that introducers (manufacturers or importers) of cosmetic toothpaste or oral hygiene Products need to register their business only if their Products meet the requirement of Therapeutic Goods (
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FCMs regulations are fast-moving to improve the protection of public health. Food contact materials (FCMs) refer to all materials and articles intended to come into contact with food, for example, packaging and containers, machinery to process fo
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  The UK will exit the transition period on December 31, 2020.  From 2021, the EU REACH Regulation will be brought into UK law under the European Union (Withdrawal) Act 2018 and this chemical regulation is also known as UK REACH. REACH, and
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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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Are you introducing soaps into Australian territory for commercial purposes to make a profit? Then you must register under AICIS. The registration duty applies only if soaps manufactured in Australia involving a chemical reaction (such as s
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On January 4th, 2021, the Brazilian National Health Surveillance Agency (ANVISA) addendum, concerning the active substance Glyphosate (G01), entered into force. The resolution RDC 441/2020 applies to all technical and formulated Products register
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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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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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Following the end of the Brexit transition period on 1st January 2021, the UK REACH Regulation is now in force. UK REACH, which has been described as mirroring its EU counterpart, applies instead of EU REACH in respect of Great Britain (England,
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ECHA has added two new substances to the Candidate List of substances of very high concern (SVHCs) for authorization on 19 January 2021. Now the list contains 211 substances in total. These two substances were added to the Candidate List as th
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In 2020 Colombia became the third Latin American country to join the OECD. As a membership requirement, the country has to develop a chemicals management system, including chemical regulation. The chemical regulation draft named integral manageme
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The European Commission announced the EU Chemicals Strategy for Sustainability on 14th October 2020, as a key commitment policy to the European Green Deal. The ambition of the European Green Deal is to ensure climate neutrality and circular econo
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    When Israel joined the OECD in 2010, the country planned to establish a national mechanism for registering chemicals. There are various regulations in Israel that regulate the practice of chemicals, aspects of import, Production, occu
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The Ministry of Health and Welfare in Taiwan circulated a list of Prohibited ingredients in Cosmetic Products on 3 December 2020. After 60 days of publication consultation, the list is now expected to come into force on 1 July 2021. Cosmetic prod
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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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  On November 19th, 2020, the Standardization Administration of China (SAC) published the Guidelines for the Use and Control of Key Chemical Substances in Consumer Products (GB/T 39498-2020), with its effective date on June 1st, 2021. 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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Grandfathering is a transitional arrangement under UK REACH that allows GB-based manufacturers and importers of a substance registered under EU REACH to continue to import or manufacture that substance in Great Britain past the end of th
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The Brazilian Health Regulatory Agency (ANVISA) has been submitting several proposals of the country’s agrochemical standards to the WTO in February. All of the modification proposals are open to public consultation until April 4th, 2021. Th
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Proposition 65, known as the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted as a ballot initiative in November 1986. The proposition protects California's drinking water sources from being contaminated with chemicals known
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Persistent Organic Pollutants (PoPs) will be added to the priority control substance list under K-REACH. The Ministry of Environment in South Korea published the national PoPs management plan on 28 January. However, the implementation date is not
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The Ministry for Development of Economy, Trade and Agriculture of Ukraine has notified the draft resolution, On Approval of the Technical Regulation on Safety of Chemical Products, to the WTO. This draft resolution lists out requirements for registra
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The Hazardous Substance Act B.E. 2535 is one of the main legislative bases involved in chemical management in Thailand. The first issue of B.E. 2535 came into force on April 7th, 1992. The Act has been revised several times. The Ministry of Indus
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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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In the context of the authorization process, Member States Competent Authorities and/or the European Chemicals Agency (ECHA), on request of the European Commission, could prepare Annex XV dossiers for the identification of Substances of Very High
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  Biocidal Products Committee(BPC) is a committee of ECHA which forms opinions on the BPR process and each member state appoints one member for BPC. Members of BPC meet regularly to discuss and the agenda for those meetings are publish
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On 23rd March 2021, Chinese National Medical Products Administration (NMPA) launched a new platform for the registration and filing of cosmetics to support the implementation of ‘Cosmetic Supervision and Administration Regulation (CSAR)’ and
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The Ministry of Environment in South Korea plans to include lubricants in the list of Products subject to safety checks. 39 consumer Products have been listed in K-BPR that will need safety checks. The draft amendment proposed to include lubrica
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Japan is going forward with a global ban on the Production, import, and use of Perfluorooctanoic acid (PFOA), its salts, and 2,2,2-Trichloro-1-(2-chlorophenyl)-1-(4-chlorophenyl) ethanol (also known as o,p’-Dicofol), as a part of its commitment ann
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On April 14, 2021, ECHA recommends for the European Commission to add seven substances to the Authorisation List (Annex XIV of REACH). Once on the list, companies will need to apply for authorisation to continue using them. The seven substance
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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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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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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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The Latin American Regulatory Cooperation Forum (LARCF), coordinated with the International Council of Chemical Associations (ICCA), published the Roadmap for the Rational Management of Industrial Chemical Substances and Products in late April 2021.
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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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Final screening assessment and proposed risk management approach  The Government of Canada under the Act of Canadian Environmental Protection Act (CEPA), has added selenium and 28 of its compounds to Schedule 1 (list of toxic substances).�
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Performance measurement evaluations provide Canadians with information on the effectiveness of the risk management actions in place for the substances that are found to be toxic under the Canadian Environmental Protection Act, 1999 (CEPA 1999).
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As convenient as single-use plastic seems to be, the challenges and adverse effects far outweigh its benefits. One of such is that 80 to 85% of marine litter in the EU is plastic material.    On the 31st of May 2021, the European
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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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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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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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The Gulf Standardization Organization (GSO), on the 7th of July 2021 issued an update to the draft Gulf Technical Regulation No. GSO 2528/2021 "Cosmetic Products – Technical Regulation of cosmetic and personal care Products claims". This was done t
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In April 2021, the Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals, India, published several orders regarding BIS certification of 13 chemicals (see Table below). These chemicals are added to the BIS Mandatory Cer
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The Philippines’ Food and Drug Administration (FDA) recently had a consultation to examine the draft of Circular to prohibit the use, manufacture, importation/exportation, distribution, sale, and storage of medical Products that contain mercury
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Canada’s environment and health ministries have suggested including solvent violet 13 to the Cosmetic Ingredient Hotlist, a move that would restrict the dye’s use in cosmetics placed in the country.   The two government agencies nomin
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The Canadian government has finalised regulations to limit formaldehyde emissions from composite wood Products and apply the country’s that generally align with that of US.  The regulation will concern the import, sale and offer for sa
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Canada’s health and environment ministries have urged the conditions on the use of phosphonic acid, P,P′-(1-hydroxydodecylidene)bis-, allowing the limited amounts of the anti-adhesive to be used in certain cosmetic Products. Since the
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A Global NGO network, International Pollutants Elimination Network (IPEN), based on its research, has found levels of Persistent Organic Pollutants (POPs) in almost all the free-range chicken eggs it collected near plastic waste disposal sites in 14
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REACH (EC 1907/2006) is a regulation aimed at improving the protection of human health and the environment through a better and earlier identification of the intrinsic properties of chemical substances. (Source: EC) The EC clarification and amendm
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China implemented CSAR in January 2021, and this was after 30 years of waiting. China recently took another massive step by approving its first cosmetics ingredients under CSAR. As recently published in the International Nomenclature Cosmetic Ing
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The National Medical Products Administration of China (NMPA) announced their working plan for the second half of 2021 on 5th July 2021. This working plan is based on the haircare Products and children’s cosmetics work done in the first half of
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The Ministry of Environment (MoE) in South Korea added the provision to expand the definition of existing substances on Aug 12th, 2021. According to K-REACH, existing substances are those listed in the inventory. The definition of existing substa
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South Korea enacted the Act on Risk Assessment of on July 27, 2021. This Act aims to protect and promote public health by evaluating risk assessment of Products applied to the human body and regulating matters of safety management. The Ministry of
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On the 6th of August, the National Medical Products Administration (NMPA) enacted “Measures for Cosmetics Supervision and Administration” which will come into force from the first day of 2022. This is the first regulation that focuses on cosmetic
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On the 26th of July, the National Health Commission of China (NHC) announced that 9 food additives and 19 food reactants were approved, according to China Food Safety Law. The above mentioned 28 substances are the following: 9 food additives:
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ECHA elucidates the rules on accepting adaptations for degradation testing and requiring combined studies for mutagenicity. It also suggests companies should consider these changes while deciding whether to update their registrations.  Ch
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On the 5th of  August, the Government of Canada nominated long-chain PFCAs, their salts and related compounds (also known as precursors) for consideration under the Stockholm Convention on Persistent Organic Pollutants (POPs). The Stockholm Conventi
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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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On July 24, Peru’s Ministry of the Environment (MINAM) published Decree 18/2021. By this Decree, Peru creates the Pollutant Release and Transfer Register (RETC by its acronym in Spanish). The new database constitutes a new informational tool of
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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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The European Chemical Agency (ECHA) announced the SCIP Database in September 2021; this is a public database for Substances of Very High Concern (SVHC) in EU Products. SCIP database is aimed at helping consumers make informed purchasing choice
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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 27th of September 2021, the new Turkish Food Codex Maximum of Pesticides Residual Limits Regulation was published on the official gazette, after a public consultation on the draft in 2020.  Like the Turkish Food Codex Maximum of Pesticide
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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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During the Biocidal Products Committee (BPC) meeting between October 5-14, 2021, it was decided not to allow the use of d-allethrin for Product-type 18, that is, insecticides, acaricides, and Products used in controlling other arthropods. The comm
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Peru and Rwanda wrote a draft resolution on the 2nd of September 2021, to address harmful substances in plastics.   The draft resolution requests that an intergovernmental negotiating committee be established to legally bind the treaty on p
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On the 28th of October 2021, the European Commission adopted the proposal on protecting human health and the environment by tightening the limits for POPs. Persistent Organic Pollutants (POPs) are the most harmful chemicals in waste, and the proposal
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On the 30th of September, the National Medical Products Administration of China (NMPA) published the final Regulations on the Supervision and Administration of Children’s Cosmetics which is expected to take effect on the 1st of January 20
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In recent months, Chile has announced three main resolutions aimed at defining the goals, obligations, annual report’s content, and the framing of Products that would fall within the packing management. Chile is truly embracing the Extended Produc
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According to the Danish Environmental Protection Agency and Danish Consumer Council THINK Chemicals, specific children’s toys have been discovered to contain some chemicals that are problematic. The Danish Consumer Council THINK Chemicals discov
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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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Circular Economy has been on the rise, and debates about its adoption, key elements, benchmarks, and range of application are prevailing than ever before. In November 2021, the Organisation for Economic Co-operation and Development (OECD) publish
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On November 17, the Mexican Senate unanimously approved the general terms for the new Circular Economy Law (Ley General de Economía Circular – LGEC ). The new legislation promotes improved waste management rules and advocates for recycling tech
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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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On the 1st of December 2021, China’sNational Medical Products Administration  (NMPA) published a special label for cosmetics that are intended for use by children under 12 years old. From 1 May 2022, newly registered children’s cosmetics must
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The European Commission adopted its new Circular Economy Action Plan (COM/2020/98 final) in March 2020.  The plan – which is one of the first deliverables under the European Green Deal (COM/2019/640 final) – lays out more in detai
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In a letter of 9 February 2021, Steve Elliott, Chief Executive of the UK’s Chemical Industries Association called upon the UK government to repeal the UK REACH requirement for duplicate registration datasets. Under the current situation, companies
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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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The European Commission published a Regulation amending several annexes of the cosmetics regulation, prohibiting certain substances from use in cosmetics. This regulation was published on the 3rd of November and came into effect on November 23, 20 da
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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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On November 18, 2021, the Ministry of Environment approved complementary provisions to Decree 9/2019, which is the current legislative instrument for the management and handling of Waste from Electrical and Electronic Equipment (WEEE). Decree 3
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On November 15 and 16, 2021, the Committee on Technical Barriers to Trade, India published and submitted eight chemicals’ notifications to the World Trade Organization (WTO). BIS certification is required by every manufacturer (Indian or foreign
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On November 15th, 2021, Taiwan’s EPA published a draft regulation that would restrict the Production, import, and sale of flat packaging materials containing polyvinyl chloride (PVC). The draft regulation is based on Article 21 of Taiwan’s Waste
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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 the 18th of January 2022, ECHA advises on how to determine and apply dose selection for dose and reProductive toxicity. This is in alignment with OECD guidelines. The director of ECHA for Hazard Assessment said the amended REACH annexes and the gu
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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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Based on the China cosmetic regulation (Cosmetics Supervision and Administration Regulation, CSAR), the National Medical and Pharmaceutical Agency (NMPA) published the good manufacturing practice ‘specifications’ for cosmetics. This notification
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Canada has embraced Volatile Organic Compound (VOC) directions for certain customer and commercial Products, setting up the most extreme concentration limits in around 130 item categories. Published in the Canada Journal this mon
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Transport Canada (TC) recently opened a discussion to revise Part 6 of the Transportation of Dangerous Products (TDG) and set new training requirements.  Published in the Canada Gazette Part 1 on 11 December 2021, the recommendations aim at prov
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The Ministry of Environment (MoE) in South Korea published and distributed a guide to serious civic accidents caused by raw materials and Products under the Serious Accidents Punishment Act (SAPA). The SAPA regulates the punishment of business own
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ECHA regularly recommends substances from the Candidate List to be included in the Authorisation List (Annex XIV to REACH), based on the information in the registration dossiers on uses and volumes of the substance. On February 2, 2022, ECHA lists
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Updated Enforcement Rule of The Consumer Chemical Products and Biocides Safety Control Act (K-BPR) came into effect on December 31st, 2021.This updated Enforcement Rule reflects matters mandated by the ‘Belief System for Biocidal Product Victims
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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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When UK REACH entered into force, all substances included in the EU REACH candidate list were ipso facto (by the fact itself) transferred into the new UK REACH candidate list. As to the substances added to the EU REACH candidate list after UK REAC
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The Ministry of Health, Labour and Welfare (MHLW) in Japan recently designated 4-methylbenzenesulfonic acid as a deleterious substance. This is an industrial substance widely used in coating Products, polymers, lubricants, and greases. Most impo
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Under EU Cosmetics Regulation, the commission banned some uses of methyl-n-methylanthranilate as a fragrance ingredient. This is an ingredient usually used in the Production of shampoos, soaps, and other beauty Products. In alignment with the initi
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On January 21, 2022, Chile published the determination decision to start the elaboration of a decree to regulate the instrument intended to prevent waste generation and promote waste recovery.The future Decree will focus on household Products, especi
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The Norwegian Environmental Agency announced on February 3, 2022, that the duty to declare annual quantities for 2021 is postponed until May 20, 2022. This occurred because the agency is improving the Product Register – the portal for chemical d
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The European Commission, after a serious struggle, recently declared resorcinol as an SVHC. This decision was made based on the endocrine-disrupting properties of human health. This decision was made by a voting process where 19 member states vote
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The Department of Chemicals and Petrochemicals (DCPC) in India has pushed back the deadlines for implementing quality control orders (QCOs) issued by the Bureau of Indian Standards (BIS) for five substances. These substances are tagged ‘specialt
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On the 13th of February, Switzerland had a vote to decide if full animal testing should be banned or not. This includes animal testing for both scientific and medical research.If voted for, the ban would include:·       a ban on the importa
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On the 2nd of September 2021, the Chamber of Senators in Mexico passed the bill to prohibit the use of animals for cosmetics testing. The bill stipulates that cosmetic Product cannot be manufactured, imported, or marketed when their final Producti
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In January 2022, Cosmetic Alliance (CA) and a representative from their allied stakeholder coalition met with Health Canada (HC) officials to discuss the ban of cosmetics testing on animals in Canada. HC is currently working on publishing a policy
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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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Since February 13, 2022, single-use plastics Products have faced a ban in Chile. Law 21.368 was published in August 2021 and aims to fight back the indiscriminate use of single-use plastics in different forms.The single-use plastic restriction is
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On February 9, 2022, the National Health Surveillance Agency (ANVISA) published a resolution addressing ultraviolet (UV) filters allowed to be present in cosmetics. In addition, Resolution 600 formally adopts MERCOSUR's resolution 44/2015 amended
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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  7 March 2022, Australia notified the changes to its laws regarding Mercury, in a bid to comply with the Minamata Convention obligations. Due to the amendment, Australia now prohibits the import and export of elemental mercury, also known as m
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Australia Competition and Consumer Commission (ACCC) reviews the voluntary Australian standard and proposes a new compulsory safety standard on February 25, 2022. This new rule mandates suppliers’ compliance to the newest standard called Austral
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On the 7th of March 2022, the EU notifies the decision to not approve N-(3-aminopropyl)-N-dodecylpropane1,3-diamine as an existing active substance for use in biocidal Products. This decision was made due to the human health risks posed by the sub
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On 16 February 2022, the Ministry of Environment, Forest and Climate Change published the Plastic Waste Management (Amendment) Rules, 2022, amending the Plastic Waste Management Rules, 2016. The Rules brought in Extended Producer Responsibility (E
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On  February 15, 2022, the National Medical Products Administration of China (NMPA) published final measures for cosmetic companies to establish systems for monitoring adverse reactions of cosmetics. It is expected to come into force on October 1
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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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In February 2022, the Ministry of Food and Drug Safety (MFDS) in South Korea proposed amendments to the ‘Regulation on Safety Standards, etc. of Cosmetics’. This is the cosmetics policy enacted in 2015 to guide the manufacture and import of co
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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 9 March 2022, the Environmental Protection Agency (EPA) announces the decision to extend the compliance date for prohibiting the processing and distribution of Phenol, Isopropylated Phosphate (3:1) [PIP (3:1)] in the US.  This applies to PIP (3
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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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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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Chile’s Environmental Ministry (MMA) promulgated on February 28, 2022, a Decree establishing collection and recycling goals for batteries and Electrical and Electronic Equipment (EEE). Furthermore, Decree 207/2022 imposes obligations associated
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On March 9, 2022, US EPA published the final rule for regulating Phenol, Isopropylated Phosphate (3:1). The regulation for this substance is promulgated under the Toxic Substances Control Act (TSCA).The final rule concerns the extension of the substa
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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 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 Health Canada’s revised in-commerce list (R-ICL) of chemicals used in food, drugs, and cosmetics no longer includes 602 substances that are not commercially active. These substances are therefore not subject to notification under the Food an
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Health Canada has recommended several changes to the pest control Products regulation which would reduce the burden on administrative and regulatory laws. Recommended Changes include the following: Extension of the validity period for cert
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The National Institution for Food and Drug Control of China (NIFDC) published the draft revision of “Safety and Technical Standards for Cosmetic” (Safety Standards) on March 31, 2022. This is the first-time revision of the Safety Standards since
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On July 24, Peru’s Ministry of the Environment (MINAM) published Decree 18/2021. By this Decree, Peru creates the Pollutant Release and Transfer Register (RETC by its acronym in Spanish). The new database constitutes a new informational tool for
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The European Commission recently added five SVHCs to the authorisation list, REACH Annex XIV due to their reprotoxic, carcinogenic or endocrine-disrupting properties.  These substances include: tetraethyl lead, 4,4'-bis(dimethylamino)
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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 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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On the 29th of March 2022, the European Commission opened a public consultation for the Cosmetic Products Regulation (Regulation (EC) No 1223/2009). The objective of this revision is to ensure human health and improve the functioning of the inter
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Per- and poly-fluoroalkyl substances, mostly referred to as PFAS, are part of Persistent Organic Pollutants (POPs) present in diverse consumer and industrial Products. PFAS has a myriad of applications due to its increased resistance and durable char
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On April 14, 2022, the Brazilian government approved the National Solid Waste Plan previously foreseen by the National Solid Waste Policy of 2010. Their main objective is to support solid waste management and planning in federal, state, and municipal
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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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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 European Commission published, on April 25, 2022, a list of substances and substance groups for which restrictions under the REACH Regulation are being proposed, prepared, or considered.   One of the lines of action under the European Uni
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On the 28th of April 2022, the Ministry of Environment, South Korea submits a draft on the labelling and advertising of chemical Products. With comments expected to close 40 days from notification, the proposal will be adopted after June 2022 and
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US EPA on the 29th of April 2022, submitted a notification to World Trade Organization, to amend the regulatory decision on Volatile Organic Compounds (VOCs).  According to US EPA, VOCs are compounds that have a high vapor pressure and low water sol
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The Brazilian Health Regulatory Agency notifies World Trade Organization (WTO) of several resolutions for cosmetics and personal hygiene Products which are proposed to enter into force with the earliest start being on May 2, 2022. Earlier in March 20
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According to notifications from World Trade Organization (WTO), several resolutions for medical devices are proposed to enter into force with the earliest start being on May 2, 2022, by the Brazilian Health Regulatory Agency. Earlier in March 2022, B
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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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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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The Ministry of Food and Drug Safety (MFDS) in South Korea updated the regulation on cosmetic safety standards on April 1st, 2022. This is to strengthen the safety management of cosmetics and protect public health, as well as strengthening the compet
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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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A leading European research institute, Oeko-Institut opened a consultation to exempt lead restriction under the EU RoHS Directive for medical devices’ Production. The expectation is to develop lead-free alternatives, which have been delayed due to
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On May 2, 2022, the European Union released a draft to amend Annex XVII to Regulation (EC) No 1907/2006. The new amendment mainly concerns articles in which Production includes the use of formaldehyde or formaldehyde-releasing substances that release
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Exports and Products involved with perfluorooctanoic acid (PFOA), its salt forms, and PFOA-related compounds are banned after the European Commission makes addition to Annex V of the Prior Informed Consent (PIC) Regulation. Echoing the Stockholm Conv
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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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The European Commission updates the glossary of ingredient names commonly used in cosmetics Production. This was done to correct the names of ingredients that were written incorrectly while some were updated to comply with the recent changes made in
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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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To prevent and handle the environmental and health concerns arising from the use of the substance; polyvinyl chloride (PVC) in Food Contact Materials (FCMs), Taiwanese authority is making efforts to ban the Production, import, and sale of FCMs that c
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On March 25, 2022, a regulation mandating toys to conform with the Thai industrial standard for toys, TIS 685 Part 1-2562 (2019) Toys: Safety requirements Part 1 – Requirements, was published in the Royal Gazette of Thailand by the Ministry of Indu
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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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On April 22, 2022, China National Center for Food Safety Risk Assessment (CFSA) announced a consultation notice on approving two new resins used in food contact materials and an expanded use of one food contact material additive.   The concer
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On April 27, 2022, the General Department of the National Medical Products Administration (NMPA) extends the deadline for submitting certain data under the cosmetic regulation from May 1 until December 31. This decision was made due to the rising ca
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The 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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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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Two amendments were announced to mandate inspection requirements for commodities subject to Restriction of Hazardous Substances (RoHS) regulation in Taiwan on February 24 and March 15, 2022. They were announced by the Bureau of Standards, Metrology a
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The amendments to the “List of Ingredients Prohibited from Using in the Cosmetic Products” were made on April 27, 2022, by the Ministry of Health and Welfare of Taiwan. The statement stipulates that cosmetics should not contain mercury, lead, or
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Health Canada has released a proposal for public comment to create a unified regulatory framework for disinfectants and sanitizers. In Canada, biocidal Products are currently governed by distinct regulatory systems. Surface sanitizers are governed
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Canada has presented a long-awaited proposal to impose strict restrictions on a range of long-chain PFASs and flame retardants, as well as bans on dechloranplus (DP) and decabromodiphenyl ethane (DBDPE). According to a Canada Gazette notice, adoptin
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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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Two Non-Governmental Organizations conducted tests on toys and other consumer Products found on sale in African and Arab countries. A report published on May 24, 2022, shows that the tests discovered about 20% of the sampled Products contain high lev
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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, there is a new intention to identify a Substance of Very High Concern (SVHC) from Belgium together with France. The substance of interest is 4,4'-sulphonyldiphenol (i.e. Bisphenol S (BPS), EC 201-250-5, CAS 80-09-1), and the fo
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According to ECHA, the once selected substance silver-polyethylenimine-chloride, as a new chemical to join in the biocides review programme now needs some new concerned business bodies to continue its approval process. The original uses applied fo
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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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Thailand published some new requirements regarding Food Contact Materials (FCMs) which will enter into force on January 3, 2023. The Thai Industrial Standards Institute (TISI) published these five mandatory standards in the Royal Gazette on April 8,
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The overhaul to “short form” warnings under Prop 65 is temporarily paused in California, the US. The Office of Environmental Health Hazard Assessment (OEHHA) has decided to keep on hold this controversial proposal and instead issue an alternative
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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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The European Commission on June 1, 2022, announced its proposal to approve didecyldimethylammonium chloride (DDAC) as an active substance for use in biocidal Products of Product-types 1 and 2. It was proposed under the Biocidal Products Regulation (B
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On June 8, 2022, the European Commission published a proposal on Polyvinyl chloride (PVC) articles that contain lead and lead compounds. The draft proposal amends Annex XVII, specifically entry 63, prohibiting the use of lead and lead compounds in PV
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In two of the recent surveillance projects conducted by the Norwegian Environment Agency (NEA), mixed results were found in random checks of kitchen equipment, where several substances were detected above the permitted limit; but non-compliance was n
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With the purpose to facilitate the “One substance, one assessment" process, the European Commission plans to review and improve the current way of how chemicals’ required data are gathered and disseminated under different EU laws. This proposal i
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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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ECHA’s Committee for Risk Assessment (RAC) has expressed its support for restricting the use of lead in ammunition for hunting, outdoor sports shooting, and fishing by adopting its opinion on ECHA’s proposal to restrict the use of lead for releva
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The Saudi Standards, Metrology and Quality Organization (SASO) published the Technical Regulation for Restriction of Hazardous Substances in Electrical and Electronic Equipment (SASO RoHS) in 2021 to take effect from July 4, 2022. The initial impleme
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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 Industry and Information Technology (MIIT) in China made an announcement explaining China’s plan to make stronger its restriction of hazardous substances in electrical and electronic Products under its RoHS-like regulation (RoHS2) w
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According to Notice No.15 of 2022 issued on May 24, 2022, by the General Office of the State Council of the People’s Republic of China, a newly approved Action Plan for New Pollutants Treatment was released aiming to improve China’s new pollutant
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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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On July 1, 2022, the Colombian Congress had the last and most important discussion about plastics among Products – and reached a consensus on an official prohibition of single-use plastics. The verdict is a combination of two bills present in Congr
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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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On the 15th of June 2022, the European Commission notified its draft decision to not approve methylene dithiocyanate as an existing active substance to be used in biocidal Products of Product-type 12. This is in accordance with Regulation (EU) No 528
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On the 10th of June 2022, Singapore published an addendum proposing the control of chemicals under review by multilateral environmental agreements. The notified measure is expected to enter into force by March 1, 2023. In February 2022, the Natio
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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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On June 14, 2022, the United Kingdom’s Secretary of State implemented Statutory Instruments (SIs) which impose the ban on some chemicals in cosmetics and toys. This is in accordance with the EU decision and based on the assessments done by the scie
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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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On 10 June 2022, the European Commission released a new recommendation updating the definition of nanomaterials that should inform EU legislation on the topic. A deliverable of the EU Chemicals Strategy for Sustainability, this new recommendation upd
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On June 22, 2022, the European Parliament adopted its negotiating position on the European Commission’s proposal for a regulation establishing a Carbon Border Adjustment Mechanism (CBAM). In the EU, certain industrial sectors must purchase the
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Contents: Registration requirements (registration types and documents required) Post-registration management
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*This webinar will be held in Turkish. Turkish description is below.As you may know, the 5th Draft of the Indian Chemicals Management and Safety Rules (CMSR) is in circulation. It is expected that Indian CMSR will come into force this year and will r
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As you may know, the 5th Draft of the Indian Chemicals Management and Safety Rules (CMSR) is in circulation. It is expected that Indian CMSR will come into force this year and will require notification (with additional data requirements) of all subst
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On May 1, 2021, China announced the Provisions for Management of Cosmetic Registration and Notification Dossiers, in which requires registration and notification of safety-related information of ingredients used in the cosmetic Product. In relation t
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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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Welcome to our webinar on "Moving Forward in KKDIK: How should companies prepare for registration process" organized by Global Product Compliance(GPC). KKDIK is an acronym in Turkish for Registration, Evaluation, Authorization and Restriction of C
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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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There are certain chemicals that are exempt from notification, even if they meet the definition of new chemical in China. Any potential notifier should confirm if the substances fall into the range of exemption before starting the registration pr
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Receiving and Evaluation Authority: The New Substance Notification receiving and decision authority rests with the Ministry of Ecological Environment, People’s Republic of China. Application Conditions: The basic situation of any simple decl
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European Unions (EU) Registration, Evaluation, Authorization (Restriction) of Chemicals (REACH) Regulation Background : REACH is a regulation of the European Union, adopted to improve the protection of human health and environment from the risk
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REACH will be governed by a nodal agency known as European Chemical Agency (ECHA). ECHA is the driving force among regulatory authorities in implementing the EU's ground-breaking chemicals legislation for the benefit of human health and the environm
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Cosmetics Directive - The Directive 76/768/EC has been governing the composition, labelling and packaging of finished cosmetic Products in the European Union since 1976 and is now replaced by the Cosmetics Regulation (EC) 1223/2009. Cosmetics Regu
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CosIng is EU's official database for cosmetic ingredients. It contains the list of ingredients used in cosmetic Products, on the basis of information supplied by the It includes cosmetic ingredients listed in previous inventory of cosmetic ing
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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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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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A list of Competent Authorities for every Member State may be found here Regulation (EC) 1223/2009 is enforced by a “Competent authority” in each member state, Each member state their own authority and enforcement Each Manufacturer/Distribu
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The competent authorities of the Member States shall cooperate with each other and with the Commission to ensure proper application and due enforcement of this Regulation and shall transmit to each other, all information necessary with a view to appl
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There is no tonnage restriction on use of cosmetic Product in the EU. Whatever quantity is placed on the market, has to be complied in accordance with the regulation. The data requirement includes Product information file (PIF) which should be read
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The term ‘manufacturer’ has a wide definition under the cosmetics legislation and includes the entity which has a Product designed or manufactured, and markets the cosmetic Product under its name or trademark. Therefore, unless it has explicit
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Prior to placing the cosmetic Product on the market the responsible person shall submit, by electronic means, the information to the commission on the online portal i.e., Cosmetic Product Notification Portal. Only one notification is necessary to
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Animal Testing Prohibited : The Cosmetics Directive provides the regulatory framework for the phasing out of animal testing for cosmetics purposes. Specifically, it establishes: Testing ban - prohibition to te
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As per the regulation only those cosmetic Products can be placed on the market, for which a legal or natural person (Responsible Person (RP)) has been designated who will be responsible to meet compliance requirements within the regulation. Manufa
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Compiling Product information profile (PIF). Checking ingredient used are of suitable grade. Producing Cosmetic Product safety report (CPSR). Safety assessments by a qualified Ensuring labelling displays (accordance with CLP regulation). App
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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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Sr.No. Business Capacity 1 Food Production capacity(othe
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Common documents required for obtaining FSSAI registration: FormA – completed and signed PhotoIdentity of FBO Proofof possession of premises (e.g
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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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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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Carryingout technology and Product development Evolvingand periodically updating the national program for technology/Product Acting as a nodal agency to monitor and ensu
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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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The Act on the Chemical Substance Control Law came into force in 1973 to prevent environmental pollution by chemical substances that pose a risk to human health or the environment. But it was later updated and amended on May 20th 2009. Full implement
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Substances which are suspected long-term toxicity for humans or flora and fauna in the human living environment. Suspected risk Mandatory reporting of actual amounts manufactured and/or imported, detailed usage, etc. Companies handling these substan
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General : Industrial Safety and Health Law (ISHL) was firstly introduced in 1972 and this law ensures the safety and health of workers in workplaces. The substances which are prohibited to manufacture or import, substances requir
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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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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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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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 ITEMS EU REACH K-REACH Registration target New substance (>=1t/y) Existing substance (>=1t/y) New substance (>=100kg/y) Existing substance (>=1t/y)
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Eurasian Economic Union members; Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia created a common Technical regulation 041/2017 "On chemical Product safety" (inofficially called Eurasia REACH). This technical regulation introduces new require
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Russia would not be able to maintain its own national standard if the Eurasian standard is implemented. Institutions involved in Technical regulation: DraG resolution of the Government of the Russian Federation on determination of the body (bod
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The compliance assessment with the requirements of the TR 041 is carried out in one of the following ways: Notification registration  For substances that are listed (e.g. notified) in the Eurasian chemical inventory: that do not 
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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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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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Please note!  Chemicals that are subject to another technical regulation are nominated voluntarily                                                                                        Informatio
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From 1 January 2020, manufacturers or importers who manufacture or import Existing Chemical Substance in an annual amount of 100 kilograms or more, should apply for the Phase One Registration within 6 months from the date of manufacturing/importin
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Chemical Inventory in Taiwan Taiwan’s Chemical substance Inventory (TCSI), was compiled jointly by two competent authorities, the Environmental Protection Administration and Ministry of Labor. The inventory contains more than 100,000 substances
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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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In Taiwan, GHS has been implemented for selected chemicals since 2008. Full GHS implementation for all hazardous chemicals including their physical and health hazards at workplace has been enforced since 2016. Both Toxic Chemical Substance Control Ac
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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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The current Hazardous Substance Act B.E. 2535 was issued in 1992 which was the important chemical control law in Thailand with a purpose of protecting human health and our environment. The Act promulgates lists of hazardous substances for particular
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There are over 1,585 entries in current Hazardous Substances List in Thailand covering various chemicals that are controlled by various authorities (including pesticides and biocides). This list is issued and maintained by the Ministry of Industry (M
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An application for registration of following hazardous substance should be submitted to the Department of Industrial Works (DIW) of MOT, or to other authorities designated by MOI by the producers or imports of below hazardous substance type:
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Hazard Substance Manufacturer Hazard Substance Importer
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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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On June 23, 2017 the Turkish Ministry of Environment and Urbanization (MoEU) published regulations for the management of substances, very similar to the EU REACH Regulation, (EC) No 1907/2006. The KKDIK regulation came into effect on December
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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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It is The part of the States Department of Health and Human Services and is one of the United States federal execuve departments. New drugs, including biologics, Food addives for people and animals, Color addives in food, drugs, and cosmecs for peopl
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The FDA exercises authority for inspecons of facilies in foreign countries which supply pharma and food Products to the US. So, pharma and food plants in countries that export to the USA must adhere to the CGMP (current good manufacturing pracces) as
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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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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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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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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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In Brazil, there are specific laws that apply to pharmaceutical Products, cosmetics, pesticides, sanitizing Products and explosives. However, there is no law applicable to industrial chemicals. In Oct 2018, the National Chemicals Safety Commission (C
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The draft law mainly applies to >=1t/y industrial chemical substances. According to the article 3 of the draft law, the following chemical substances are out of scope. Radioactive substances Substances in development or solely for research
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New substances and certain existing industrial chemicals on the inventory will be selected for hazard evaluation by Industrial Chemicals Assessment Technical Committee if they meet the following criteria: Persistent, bio-accumulative or toxic t
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According to the Administrative Licensing Law, the applicant has the following rights according to law: If the applicant meets the statutory conditions and standards, the applicant has the equal right to obtain an administrative license accordi
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Any registrant who, in violation of this Provision, has one of the following wrongful acts shall be subject to a fine of RMB10,000 at least and RMB30,000 by the local environmental protection authorities. In this case, the local authorities are empow
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Details required to register polymer as a new substance in CHINA Exact IUPAC name of the polymer - "Before searching IECSC, it is very important for a company to know the nomenclature rules in China. The Chinese name of a polymer should be name
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Article 1 These Measures are formulated in accordance with relevant laws and regulations and the Decision of the State Council on the Establishment of Administrative Permits for Administrative Approval Projects that are necessary to retain new chemi
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The following Products or substances do not apply to these Measures: (1) medicines, pesticides, veterinary drugs, cosmetics, food, food additives, feed, feed additives, fertilizers and other Products, except for new chemical substances that are ch
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Article 4 The State shall implement a system of environmental management and registration of new chemical substances. The registration of environmental management of new chemical substances is divided into routine registration, simple registratio
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Article 7 Enterprises and institutions engaged in the research, Production, import and processing of new chemical substances shall abide by the provisions of these Measures, take effective measures to prevent and control the environmental risks of n
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Article 10 Where the annual Production of new chemical substances or the import volume of more than 10 tons, the general registration of environmental management of new chemical substances shall be conducted (hereinafter referred to as the regular r
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Article 11 An applicant for the registration of environmental management of new chemical substances shall, in accordance with the law within the territory of the People's Republic of China, be able to bear legal responsibility independently, and
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Article 29 Before a new chemical substance that has obtained a regular registration certificate is listed in the "Inventory of Existing Chemical Substances in China" in accordance with Article 44 of these Measures, the holder of the registration cert
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　 Article 31 The following chemical substances listed in the "Inventory of Existing Chemical Substances in China" in accordance with Article 44 of these Measures shall be subject to new-use environmental management: 　　 (1) Highly hazardous c
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Article 41 The holder of the registration certificate shall report the first activity of the new chemical substance to the competent department of ecological environment under the State Council within 60 days from the date of the first Production or
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Article 42 If researchers, producers, importers and processing users of new chemical substances discover that new chemical substances have new environmental or health hazard characteristics or environmental risks, they shall promptly report them to
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Proposition 65, officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted as a ballot initiative in November 1986. The proposition protects the state's drinking water sources from being contaminated with chemical
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　　 Article 44 If a new chemical substance that has obtained a regular registration certificate has reached five years from the date of its first registration, the State Council department in charge of ecology and environment shall include it in
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　 Article 44 If a new chemical substance that has obtained a regular registration certificate has reached five years from the date of its first registration, the State Council department in charge of ecology and environment shall include it in the
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Article 46 Anyone who, in violation of the provisions of these Measures, obtains the registration of environmental management of new chemical substances by improper means such as deception or bribery shall be ordered by the competent department of e
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Chapter VI Supplementary Provisions 　　 Article 52 The meaning of the following terms in these measures: (1) Environmental risk refers to the degree and probability of harmful effects on the environment and health after chemical substances with
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 A manufacturer or importer (introducer) of industrial chemicals or Products that release industrial chemicals — into Australia for commercial purposes must register their business if not alread registered with previous regulation NICNAS. This
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The Consumer Chemical Products and Biocide Safety Management Law (known as K-BPR) concerns the placing on the market and use of hazardous consumer chemical and biocidal Products, which aims to protect public health and environment from these chemical
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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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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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As per the recent amendment of K-BPR on March 24, 2020, the concept of Only Representative (OR) is included in the law, which will take into force on January 1, 2021.  OR is an intermediary appointed by a foreign manufacturer based outside of South
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Biocides approval process begins with submitting approval application. Once the authority initiates the assessment, a notice informing approval assessment initiated will be sent to the applicant. In six months from the date of the notice, approva
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Each biocides use approval has expiration period.   1. Biocidal substance Expiration period Criteria 10 years Biocidal substance 7 years A biocidal substance that its approval criteria
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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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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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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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1. Did the EU ban Single-use plastics? Yes, the EU has banned single-use plastic Products to reduce the danger these non-recyclable Products pose to our environment. 2. What is the new EU Single-use Plastic Directive about? The new EU Single
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Single-Use Plastics Directive (SUPD) On the 31st of May 2021, the European Commission released a new directive on single-use Plastics. The new EU Single-Use Plastic Directive aims to make further clarifications about plastic Products that fall
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According to the Cosmetic Act, cosmetics include two main categories: functional cosmetics and general cosmetics. Some articles in the Cosmetic Act particularly applies to functional cosmetics. For instance, a person or company who is involved in the
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 1. Main requirement for manufacturers and manufacturer-seller   Manufacturer Manufacturer-Seller Definition Manufacturing all or part of the cosmetics* (*This excludes manufacturi
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* 16 categories:      1) Information about the chemical Product and company      2) Hazard and risk assessment      3) Name and content of ingredients      4) First Aid Measures      5) How to deal with explosions and fi
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The BIS in BIS Certification stands for Bureau of Indian Standards. The establishment of a national standards body in India is based on the Bureau of Indian Standards Act established in 2016.   The aims of the BIS Act include harmonious developm
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  The main authority that is responsible for the registration, approval or restriction of agrochemicals sold in Australia is Australian Pesticides and Veterinary Medicines Authority (APVMA). The regulation of the use of pesticides is regulated by E
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Law 7802 (Pesticide Law) established Brazil's current pesticide legislative framework, which governs pesticide research, experimentation, Production, packaging, labelling, transportation, storage, marketing, commercial-advertising, utilization, i
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Law 7802 (Pesticide Law) established Brazil's current pesticide legislative framework, which governs pesticide research, experimentation, Production, packaging, labelling, transportation, storage, marketing, commercial-advertising, utilization, i
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The applicant must submit the application and its attachments in triplicate to the above-mentioned federal agencies in the agriculture, health, and environmental sectors. The applicant must submit the application and its attachments in triplicate
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After Submission for the Registration:  1. Submission of the Product registration will be reviewed by all the Authorities. 2. MAPA expresses an opinion on whether the proposed Product is appropriate to reduce the Efficacy Evaluation, Phytotoxicity
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When a Product is intended to be further processed, the law does not require it to be labeled as a retail item. However, the exporter must provide all required information to the importer. The information provided by the exporter does not have to be
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Chinese cosmetic regulation came into force on January 1, 2021. It regulates all the cosmetics and cosmetic raw materials in China. All the manufacturers, importers and exporters must ensure that their cosmetic Products and raw ingredients meet the c
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China's State Council published the final version of the COsmetic Supervision and Administration Regulation (CSAR) and this came into force on 1 January 2021 and replaced the Cosmetic Hygiene Supervision REgulations. CSAR regulates all cosmeti
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Cosmetic raw material is defined as natural or synthesis ingredients which are used in making cosmetic Products. According to the requirements, existing ingredients need to do record filing submission, while new ingredients must do a formal registra
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New raw ingredients are defined as cosmetic ingredients that are not listed in the IECIC inventory. Applicants need to submit the following documents to comply with CSAR: Applicant’s details which include name, address, and contact. Researc
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The registration timeline of cosmetic Products is the same as cosmetic ingredients registration. But the submission documents are different. For cosmetic Products registration, applicants need to prepare: The name, address, and contact informatio
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For imported cosmetics, they must be labeled in Chinese and contain the following information: Product name, special cosmetics registration certificate number The name and address of the registrant, recorder, and entrusted Production enterprise
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CSAR also introduces the annual reporting requirements. Applicants should submit the annual report of cosmetics from January 1 to March 31 each year. Basic information and Production of new cosmetic ingredients. Information on cosmetic registran
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Decree 7074 specifies the required material, label format, and layout, as well as the elements and text content of pesticide labels and Product manuals. To indicate the Product hazard to the user, a color band should be placed on the pesticide label
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Fertilizers and Farm Feeds Parliament approved the Agricultural Remedies and Stock Remedies Act in 1947, which regulates pesticides and their use, among other things. The Act has been changed several times since then, but it has never been comprehens
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To register a pesticide Product in South Africa, the applicant company must have a local legal entity to represent them. ​ A legal entity might be a person or a firm registered with the Department of Trade and Industry under the Company A
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Registration consists of the following steps: Five batch analytical reports are used to verify chemical and toxicological equivalency. Data from a GLP (Good Laboratory Practice) approved independent laboratory is required. Details about the pr
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On December 31, 2021, China’s National Medical Product Administration (NMPA) launched an online cosmetic ingredient submission platform. This platform, Cosmetic Ingredients Safety Information Registration Platform, will require companies handing ex
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GPC can : Act as a Responsible Person to place you Products on the EU market Gather all the documents required for the elaboration of PIF  Review your formulation  Test the physic-chemical properties of your Product  Test the microbiology
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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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The Responsible Person in GB  A cosmetic Product cannot be placed on the GB market unless there is a Responsible Person established in the UK in respect of that cosmetic Product. Like for the EU market, the Responsible Person will have to ensure co
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Anyone who is registered under AICIS to introduce industrial chemicals or Products containing industrial chemicals (for example, cosmetics, paints and plastics) must submit an annual declaration. This applies to all of your chemical introductions, r
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Product Chemistry: Methods and validation for identification and content determination of limited components such as softener, stabilizer and synergist were added. Conformity between data/sample and actual Production process will be carefully scr
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The numbers for the development licence are in the form of 'XK13-***- * * * * * *.' 'XK' is the abbreviation for a licence for the development of pesticides, and '13' means that a licence has been given to a pesticide company.
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The Australian Pesticides and Veterinary Medicines Authority is responsible for the registration, approval, and restriction of agrochemicals sold in Australia (APVMA). The use of pesticides is regulated by the Environmental Protection Agency (EPA) un
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In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this prog
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In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this prog
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The FDA regulates food, drugs, medical devices, biologics, cosmetics and radiation emitting Products in the USA.  FDA’s Centre for Devices and Radiological Health (CDRH) is responsible for regulating manufacturers of medical devices. Medi
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The FDA does not “certify" devices, and the FDA logo is for the official use of the FDA and not for use on private sector materials. The FDA does not issue registration certificates to medical device facilities nor does the FDA certify info
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The regulation of medical devices is primarily concerned with enabling patient access to high quality, safe and effective medical devices, and avoiding access to Products that are unsafe. When appropriately implemented, regulation ensures public heal
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The registration of a pesticide is a scientific, legal, and administrative process consist of examination of pesticide's ingredients, the specific site or crop where it will be used, the amount, frequency, and timing of its application, as well a
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Human Health risk  a. Risks in the aggregate–from food, water, and residential uses  b. Risks accumulated over time from several pesticides with similar effects  c. Occupational hazards for people who use the Product at work  Env
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https://www.epa.gov/pesticide-registration/about-pesticide-registration#:~:text=Federal%20Insecticide%2C%20Fungicide%2C%20and%20Rodenticide%20Act%20(FIFRA)%20%2D,benefits%20of%20a%20Product's%20use
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The 67th WHA(World Health Assembly) approved the resolution “Regulatory system strengthening for medical Products”. It states the importance of regulations for medical devices as one of the medical Products, for better public health outcome and t
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Agricultural and Veterinary Chemicals (Administration) Act 1992 The APVMA is established as an independent Commonwealth statutory authority responsible for the regulation and management of agricultural and veterinary chemicals in Australia up to the
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The Product label is the primary and most effective means of communicating to users' critical information about pesticide and veterinary drug use that is both safe and effective. Current pesticide and veterinary medicine labelling, on the other h
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Circular Economy Action Plan Presented in March 2020, the EU Circular Economy Action Plan singles out some key industries where regulatory action will be focused. These are:   Electronics and ICT    Batteries and vehicles   
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Chemicals Strategy for Sustainability  The European Commission presented its Chemicals Strategy for Sustainability in October 2020, with an overarching goal of eliminating or minimizing the use of hazardous substances. This is expected to bring pos
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Chemicals Strategy for Sustainability The European Commission presented its Chemicals Strategy for Sustainability in October 2020, with an overarching goal of eliminating or minimizing the use of hazardous substances. This is expected to bring posit
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India plant protection Product registration is intricately challenging task due to various categories of registration.   Identifying a suitable category for your Product needs to be established and it some time happens with the conformi
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A notified body is an organization designated by an EU country to assess the conformity of certain Products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislat
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EU Regulation1107/2009 established the plant protection industry. Plant protection Products (PPPs) in the European Union under Regulation (EC) No 1107/2009 Data requirements have increased, and risk assessment schemes have become more complex. The Eu
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EU Regulation1107/2009 established the plant protection industry. Plant protection Products (PPPs) in the European Union under Regulation (EC) No 1107/2009 Data requirements have increased, and risk assessment schemes have become more complex. The Eu
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The data requirements are set out in Regulation (EU) No. 283/2013 for the active substance and in Regulation (EU) No. 284/2013 for the Product formulation along with national requirements which are specific to each Member State. However, writing EU r
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The Reorganization and Rationalization Plan for Special Public Corporations that was approved in a Cabinet meeting in 2001, was followed by the establishment of the Pharmaceuticals and Medical Devices Agency (PMDA) and came into service on April 1, 2
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Medical device companies interested in offering their Products in Japan must comply with Japan's Pharmaceuticals and Medical Devices Act (PMD Act). Complying with the PMD Act can be challenging for foreign manufacturers, as very few regulatory do
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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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Following provisional clearance for limited use, the pesticide registration procedure begins with two years of testing and inquiry. An advisory committee comprised of representatives from several ministries, including Environmental Protection, Health
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All applications for consideration of approval of PCP must be accompanied by submission of risk assessment reports (2019/2021- Risk assessment workshops).​  Risk assessment report needs to be submitted: (1) During submission of summary dossi
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The China Food & Drug Administration (CFDA), now called the National Medical Products Administration (NMPA), is responsible for medical devices, drugs, and healthcare services. The organization is headquartered in Beijing, with offices in e
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The China Food & Drug Administration (CFDA), now called the National Medical Products Administration (NMPA), is responsible for medical devices, drugs, and healthcare services. The organization is headquartered in Beijing, with offices in e
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Applicants needs to provide the summary of risk assessment:​  Quality of the data referenced for hazard assessment (e.g., Experimental design and quality of the critical study or studies).​  Kenya Good agricultural practice (GAP
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The Fertilizer and pesticides authority of the Philippines is responsible for regulating plant protection Products (PPP). It draws its power from Section of PD 1144, which states that the Fertilizer and Pesticide Authority (FPA) has jurisdiction over
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To promote the safe use of plant protection Products and dissemination of the correct information among society.   The Philippine Council for Agriculture and Resources Research and other authorized agencies; works in tandem with each o
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  Product Identity - The Product name and trade name(s) must be included in each authorization of a biochemical PCA that is a pesticide Product (if different). It's possible to provide the corporate code number(s).  Confidential St
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In June 2021, the NMPA issued a new set of regulations that will make it easier for innovative medical devices for the treatment of urgent public health emergencies and rare diseases to obtain approval in China.   Certain Products will be
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Plant Protection Products (PPPs) are registered according to PPPs regulation; 27885/25.03.2011 in TURKEY. The regulatory body of the turkey is the General Directorate of Food and Control (DGFC) of the Ministry of Agriculture and Forestry (MinAF), is
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Product Risk Analysis Document  Product Technical Specification  Product Testing Report (company’s self-testing report or 3rd party report)  Clinical Evaluation Report  Key Manufacturing Information (process, flowchart, material, etc.) 
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Plant Protection Products (PPPs) are registered according to PPPs regulation; 27885/25.03.2011.   1. According to the above regulation, applicants must receive a certificate showing their commercial activity in the Pesticides Industry from the Min
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License Application:  Article 17-    1.The license application files are submitted by the company to the General Directorate on a Product-by-Product basis.   2. The information provided in these files can be readily accessible during the
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It is generally expected that the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) will be adopted for pesticides. The biggest impact of GHS on pesticides will be pesticide classification and Product labels. While G
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The pesticide legislation and regulations in the countries share the following basic concepts:  * Submission of application to register for pesticide use, with required data and other information, and a draft of a label; * Formation of a Technical
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Plant protection Products (PPPs) contain both traditional synthetic pesticides and biopesticides.  According to Regulation (EU) No 1107/2009, placing PPPs on the EU market requires two procedures. To begin, the active chemical is reviewed and approv
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The data requirements for active substances are listed in Regulation (EU) No 283/2013. Chemical active substances should comply with the data requirements in Part A of this regulation and microbial active substances should comply with the data requir
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All the substances used in making plant protection Products have been audited regularly by the audit team of both the member state and the Commission. Rules and Regulations are dynamic and keep on evolving with rapid growth in scientific and technolo
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The pesticide legislation and regulations in the countries share the following basic concepts: * Submission of application to register for pesticide use, with required data and other information, and a draft of a label; * Formation of a Technical A
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Register one trade name for each active ingredient, technical-grade drug or finished Product for pest prevention and control or crop growth regulation. In case such active ingredient, technical-grade drug or finished Product is used for disinfectio
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The labeling requirements of the countries implementing a registration system are almost completely harmonized based on Relevant FAO guidelines: All countries require the printing of labels in both the national language and the dialect of the loc
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The Regulations for Pesticide Registration were promulgated in 1992 by the Ministry of Agriculture and Food Industries; the Plant Production and Protection Department (PPPD) became the implementing authority. Efficacy protocols have been incorpora
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The Ministry of Agriculture of the Russian Federation No. 357 approves the registration process of agrochemicals in Russia. The Federal Law based on the “Production and consumption waste”, in compliance with Article 14 every legal entity and in
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The general obligations for the Products to contain in their label are it should have the name of the Product, manufacturer data, net volume or weight, Composition, GMO related information, storage conditions, use-by-date or expiry date, Production a
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The Federal Law based on " Production and Consumption Waste" and "On approval of the Federal Waste Classifier ", belonging to the order of the MNR of Russia No.786 differentiates waste based on its origin, physical state, aggregative, hazardous prope
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According to Article 2.3 of the Pharmaceutical Affairs Law, “cosmetics” is defined as articles with mild action on the human body which are intended to be applied to the human body through rubbing, sprinkling or other similar methods, aiming to c
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Cosmetic Product refers to any substance or preparation intended to be placed in contact (by applying to, massaging or rubbing into, sprinkling or spraying on, dropping onto, introducing into, perfuming, or by any other means.  
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The ingredients "The ingredients of cosmetic Products, including the impurities they contain, must not contain anything that could cause infection or make the use of cosmetic Products hazardous to health” --Standard for Cosmetics To help the manu
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The cosmetic control in Thailand has been implemented by the Cosmetic Act B.E. 2558 (2015) which is under the regulation of Thailand FDA. The ASEAN Cosmetic Directive originated under the agreement of the ASEAN Harmonized Regulatory Scheme and the re
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Regulations  Implementation Date  Status  Cosmetic Act B.E. 2558 (2015)  2015-9-9  In force  Regulations of Notification Receipt  2018-08-23�
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Any company or a single individual who wants to import or manufacture cosmetics Product for sale in the kingdom, must inform about the complete details of cosmetic Product to be imported or manufactured to the authority of concern.   The s
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Notify the information of cosmetic Products to the authority prior to producing or importing. Once the information is completed and correct, the applicant will receive the notification receipt which is valid for 3 years.  Manufacture or imp
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Permission for manufacturing or importing samples of Products for registration is required before the registration process begins. The manufacturer or importer shall submit an application with attachments to FDA for review. The Requirements for Regi
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Any Products having pharmaceutical characteristics such as those affecting or altering the functions or structure of human body or presenting as pharmaceutical Products are outside the scope of cosmetic regulation. List of names of cosmetic Product
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Agricultural and Veterinary Chemicals (Administration) Act 1992- The Australian Pesticides and Veterinary Medicines Authority (APVMA) is established as an independent Commonwealth statutory authority responsible for the regulation and management of
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Within a month of receiving an application, the APVMA conducts a preliminary assessment. This is to see if the application fits the application requirements, in other words, if the applicant has provided the APVMA with all the necessary information a
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The person, corporation, or organisation in charge of a registered chemical Product – or an approved active constituent – is accountable for adhering to the Agvet Legislation on an ongoing basis. This can include ensuring that their Product or ac
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The APVMA has yet to issue any formal rules on the registration and regulation of nanomaterials-containing Products. When the person applies to register a Product that contains nanomaterials, the basic guideline is that one should include information
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As per the data found on “new active ingredient registration status (2000-2021)” in the pesticide regulations, the following tests/studies were required before the ingredient could be reviewed- Chemical- Silver chloride Phase 1: Product ch
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As per the data found on “new active ingredient registration status (2000-2021)” in the pesticide regulations, the following tests/studies were required before the ingredient could be reviewed- Chemical- Silver chloride Phase 1: Product chara
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National Level The Ministry of Health (MOH); is responsible for food hygiene, chemical contamination, food borne disease control, permission and inspection for new food, new food contact articles and food contacts additives notification approva
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Plastic Containers and equipments This Resolution applies to packaging and equipment constructed or covered with plastic material for domestic use, including coatings and accessories intended to come into contact with food, mineral and table water
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GMC 46/06 i.e. Technical regulation for metallic packages and articles for food contact. This rule applies to packages, coatings, and Products made of coated or non-coated metallic materials that are meant to come into contact with food particles
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The Framework Regulation No. 1935/2004 is the basic community legislation that covers all the Food Contact materials and articles. It basically defines what exactly are “Food Contact Materials” and sets the basic requirement for these materials.
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Community legislation on FCM covers the following: - 1. Materials already in contact (packaging of prepacked food) 2. Materials intended to come in contact with food (cups, utensils) 3. Materials expected to come in contact (table top, refrigerato
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Comprehensive Summary: The rationale for the notifier's conclusion that the usage of the FCS is safe should be summarised and discussed in detail in an FCN. While addressing all safety data given in the warning, the summary should describe cumul
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Due to the introduction of the Food Contact Notification the number of Food Additive Petitions has reduced substantially. Nevertheless, the FDCA states that the FCN process will be used for food contact substances authorizations except where FDA decl
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The FDA's toxicological evaluation is based on a tiered approach and is consistent with the general principle that increased exposure results in increased potential health risks; however, the inherent toxicity of a structural/functional class of
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Milk and Milk Products Automatic Sealing of the containers and the filling of the contains(bottles) must be done mechanically Reusable containers must not be used in case of milk and its Products unless it has a container that can actually be use
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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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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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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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- A Chemical Safety Assessment (CSA) recorded in a Chemical Safety Report (CSR) is required under Annex I of REACH for Production/import volumes of 10 tonnes or more per year. This involves a hazard evaluation, and if the chemical fits the categoriza
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Special considerations for a set of tests and standards have been stated based on EU legislation for food-related nanotechnology applications (ESFA, 2011). Another aspect of nanomaterial’s regulation is the economic parameters for using nanotechn
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The main regulatory framework for cosmetics in the EU is EU Regulation 1223/2009. Based on this structure, a list of all NMs used in cosmetics should be available to all consumers. Most recently (i.e., October 2019), the EU updated the existing guida
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In May 2012, the Regulation on the marketing and use of biocidal Products was enacted. The European Chemicals Agency oversees the biocidal Product authorization procedure. The definition of the word "nanomaterial" provided by the European Commission
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Finished Pesticides refers to the following drugs or biological Product:  those used to control pests of agricultural and forestry crops or their Products those used to regulate the growth of agricultural and forestry crops or affect their phy
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Who is affected?  Pesticide manufacturers engage in the manufacture, processing, and repackaging of pesticides, and importers of pesticides in Taiwan need to comply with the Pesticide Management Act and apply for licenses.    Timeline  Pesti
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Nanomaterials and nanotechnology Products are also subject to five general environmental standards in the United States. Table 2 illustrates where any nanomaterials-containing items fall under the purview of these five Acts. From 2009 to 2014, the EP
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Any chemical that is imported or made in the United States but is not listed by the Environmental Protection Agency (EPA) is a novel chemical that should be added to the list before being sold in the United States. The Toxic Substances Control Act (T
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The Food and Drug Administration (FDA) in the United States is in charge of ensuring the safety of food additives, food contact materials, and feed additives that are put on the market under the Federal Food, Drug, and Cosmetic Act (FFDCA) (US-FDA).
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The FDA's existing regulatory framework for nanotechnology-enabled cosmetics is in flux. In 2007, the FDA established a task force to explore the future of nanotechnology goods. The FDA has now issued advice on nano-enabled cosmetics safety (FDA,
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New pesticides: refer to pesticides whose active ingredients have not been approved and registered in China, including new pesticide technical (parent drug) and new pesticide formulations. Technical medicine: refers to the Product obtained in the pr
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The name of the pesticide should use the Chinese generic name of the pesticide or the simplified Chinese generic name, and the name of the botanical pesticide can be represented by the plant name plus the extract. The name of the directly used sanita
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Pesticide manufacturers, companies exporting pesticides to China, or developers of new pesticides will need to apply for pesticide registration in China, depending on their roles there are different requirements apply. Domestic applicants apply for
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The applicant shall submit the Product chemistry, toxicology, efficacy, residues, environmental impact and other test reports, risk assessment reports, labels or instruction sheets, Product safety data sheets, relevant documents, application forms, a
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Review and decision will take at least 11 months.  The provincial agriculture and rural departments shall, within 20 working days from the date of accepting the application, conduct a preliminary examination of the materials submitted by the applic
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Provincial agricultural and rural departments should report monitoring and evaluation results to MARA in a timely manner. The holder of the pesticide registration permit shall collect and analyze the safety and effectiveness changes of pesticide p
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New Chemical Substances (refers to those not listed in the inventory) can be registered in three types under the TCCSCA: Standard registration: at 1 ton or more Simplified registration: at 100 kilograms or more, but less than 1 ton Small quanti
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S. No. Applications Examples 1. Energy storage, Production, and conversion Novel hydrogen storage systems based on carbon nanotubes and other lightweight nanomaterials Pho
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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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Nanomaterials have been used in Japan for some time in Products such as home appliances, food, food containers, cosmetics, automobile parts, pharmaceuticals, paints and inks, and textiles.
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Nanotechnology in Japan has been controlled under existing regulatory frameworks for the safe management of tiny particles, such as the Roudou Anzen Eisei Ho (the Industrial Safety and Health Act) and the Haikibutsu Shori Ho (the Chemical Substances
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In order to establish effective safety measures, the Ministry of Economy, Technology, and Industry (Meti) has focused on hazard testing and risk assessment. It produced a study in March 2009 that suggested broad safety procedures for preventing occu
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International effort in addressing POPs starts in the late 1990s. The initial protocol to address POPs was implemented in 1998, signing 16 chemicals to phase out according to previously established risk criteria. The Aarhus Protocol also impose parti
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The EU is a party to the United Nations Economic Commission for Europe (UNECE) Air Convention (renamed in 2020; previously the UNECE Convention on Long-Range Transboundary Air Pollution (CLRTAP)). The Air Convention’s 1998 Aarhus Protocol on Persis
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International effort in addressing POPs starts in late 1990s. The initial protocol to address POPs was implemented in 1998, signing 16 chemicals to phase out according to previously established risk criteria. The Aarhus Protocol also impose parties t
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International effort in addressing POPs starts in the late 1990s. The initial protocol to address POPs was implemented in 1998, signing 16 chemicals to phase out according to previously established risk criteria. The Aarhus Protocol also impose parti
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China signed the Stockholm Convention on its launch in 2001 and ratified the Convention in 2004. Since then, the initial list of 12 POPs listed in the Stockholm Convention entered the government agenda. For example, the Regulation for Pesticide Manag
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Producers and importers of hazardous substances and mixtures to the Norwegian market have to follow the Regulations on declaration of chemicals to the Product register (declaration regulations), enforced on June 1, 2015. Applicants need to submit in
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Businesses producing or importing 100 kg or more of a chemical substance are to declare their Products, where the registration must take place by the latest when manufacture, market placement, or professional use begins in Norway.    Aside from t
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The annual deadline for quantities report is Mar. 15th, where annual quantities of chemicals processed must be reported for the entire previous year in unit tons, including chemicals discontinued during the previous year.   However, the deadline f
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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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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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Substances actively used in biocidal Products are regarded as already registered, as biocidal Products and their active ingredients are covered by Biocidal Products Directive. However, several conditions have to be fulfilled to benefit from the
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