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ECHA’s new online Service, the EU Chemicals Legislation Finder (EUCLEF), gives companies access to a free-of-charge overview of 40 pieces of EU chemicals legislation they may need to comply with.
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To assist us in maintaining efficient Services during the COVID-19 pandemic, we now prefer that you submit new chemicals applications electronically where possible.
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With Brexit being implemented, The UK has formally left the EU on 31st January 2020 with a withdrawal deal and has now gone into an 11-month transition period which is most likely to end on 31st December 2020. The negotiations between the UK and the
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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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According to Taiwan’s Toxic and Concerned Chemical Substance Control Act (TCCSCA), new and existing substances must be registered in Taiwan. The first batch of 106 PECs was published on 11 March 2019. Taiwan’s EPA published the draft of Guidance
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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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MEP Order NO.7 has been China’s main chemical regulation since 2010 and it only controls new chemicals. The regulation has been revised by the Ministry of Ecology and Environment (MEE) and the revision of MEP Order No.7, Measures on the Environme
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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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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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According to Taiwan’s Toxic and Concerned Chemical Substance Control Act (TCCSCA), new and existing substances must be registered in Taiwan. The first batch of 106 PECs was published
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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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Unlike EU-REACH, K-REACH requires manufacturers and importers to register polymers. Based on definitions and scope of polymer registration specified in K-REACH, they shall either register manufactured and imported polymers or apply for an exemption c
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In a private and recent communication from June 2020, the Health and Safety Executive (HSE) has communicated to GPC (Europe) AB that during this transition period, the UK will remain within the EU-REACH regulatory framework and the UK businesses need
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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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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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On November 3rd 2020, Australian government announced that introducers (manufacturers or importers) of cosmetic toothpaste or oral hygiene products need to register their business only if their products meet the requirement of Therapeutic Goods (
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On November 11.2020, the chemical registration IT System of KKDIK (Turkey REACH) was updated. The updated system is more user-friendly and slightly different than the previous one in terms of usage and information requirements.
Previously, reg
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The recent MSDS amendment in South Korea was enforced on 16 January 2021. This amendment requires chemical manufacturers and importers to deliver and submit an MSDS to the competent authority (Korean Occupational Safety and Health Agency, KOSHA
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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 Australian Industrial Chemicals Introduction Scheme (AICIS) has been implemented since July 1st 2020. Under this Scheme, introducers of chemicals have the obligation to submit an annual declaration. The first deadline of the annual declaratio
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Under the New Substance Program, Environment and Climate Canada and Health Canada are responsible for administering the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms
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As per Canada’s New Substances Fees Regulations, fees must be provided with each New Substance Notification (NSN) package submitted under the New Substance Notification Regulations (Chemicals and Polymers). The amount of fee will be depen
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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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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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The Government has appointed Graeme Barden as the new Executive Director of the nation’s industrial chemicals assessment and regulatory body, the Australian Industrial Chemicals Introduction Scheme (AICIS).
The regulatory authority has
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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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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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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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On the 16th of January 2022, China’s Ministry of Emergency Management (MEM) launched a
new online platform for the registration of hazardous chemicals. The previous
system launched in 2020 was closed on January 28, after which the new Hazardous
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On the 23rd of February 2022, the REACH Annex XV restriction
dossier was published addressing PFASs’ risks in firefighting foams to human
health and the environment. The European Chemicals Agency (ECHA) proposes an EU-wide restriction on all
per
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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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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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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
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Welcome to our webinar on "Moving Forward in KKDIK: How should companies prepare for registration process" organized by Global Product Compliance(GPC) and Indian Chemical Council(ICC).
The description of the webinar:
KDIK is an acronym in Turkish
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Welcome to our webinar on "How to comply with K-REACH" organized by Global Product Compliance(GPC) and Indian Chemical Council(ICC).
The description of the webinar:
The Act on Registration and Evaluation of Chemical Substances (known as K-REACH)
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The format and content of Safety Data Sheets (SDS) are set by the Code of Practice for the Preparation of Safety Data Sheets for Hazardous Chemicals.
Following are some important points to note:
Standard 16-SE
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Chemicals introduced solely for research, development or analysis in quantities of not more than 100kg/year
Chemicals introduced at a port or airport that remain subject to Customs and Border Protection Service control, are
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A rejection notice will be issued if the NSN package contains significant omissions or errors in the mandatory information requirements. This notice will describe all deficiencies in the NSN package. Original documentation may be returned. If the e
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The total registration costs mainly consist of three parts:
Data fees paid to lead registrant or Consortium to purchase letter of access to refer to the common parts of registration dossier. The fee is tonnage dependent. Data fee v
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Cooperation between competent authorities:
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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Manufacturer, the Responsible Person and GMP
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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GPC's TCCSCA Compliance Service
GPC is in the process of setting up a Taiwan based office to provide our TPR Services. We are willing to guide you through TCCSCA compliance process and ensure you and your company to stay competitive in the Taiwanese market. Our TCCSCA compliance se
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Hazard Substance Manufacturer
Hazard Substance Importer
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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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Latest from Brexit!
The UK has formally left the EU at 23:00 GMT on 31st January 2020 with a Withdrawal deal.
This has only marked the next step in the Brexit process. Post-Brexit, the UK has now entered a transition period until 31st December 2020 (also known as the
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Change of Regular and Simple Registration
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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Background and Types of Certification
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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Labelling
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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Who is affected?
Companies involved in the manufacturing, formulation, repackaging, exportation, importation, marketing, and application Service of pesticides shall file the registration application. The registration can be categorized as product registration, specia
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Main changes to Regulation (EC) 1223/2009
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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Medical Devices Regulation in the United States
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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Legal Basis and the Authority
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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Device Registration
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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Overview
1. US Environmental Protection Agency (USEPA): It established maximum residue levels for the reregistration and reassessment process. When exemption is found to be a safe candidate then tolerance exemptions are granted exceptionally.
2. US Food an
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Product Registration
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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Legal Basis
With regard to the regulation of medical devices, the MHLW's tasks include:
Registering manufacturers
Licensing certain actors (MAH, dealers and repair Service providers)
Enacting ministerial ordinances, guidelines and ind
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Legal Basis and the Authorities
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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Japan- Medical Devices
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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India- Medical Devices
In India medical device are governed by CDSCO (Central Drugs Standard Control Organization) which is regulated by Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
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Legal basis and the Authorities
In India medical device are governed by CDSCO (Central Drugs Standard Control Organization) which is regulated by Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. Many committees have been set up and
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Overview
Pesticides used in agriculture and public health make up a major portion of all chemicals used in Israel. To maintain environmental health and safety, the use of these pesticides is closely monitored. The Plant Protection and Inspection Service of th
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Registration
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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China- Medical devices regulation
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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Legal Basis and Authorities
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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Product Information
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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Labelling, Packaging & Disposal
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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Authorties
National Service of Agricultural Food Health and Quality (SENASA), Argentina's pesticide management body, is in charge of pesticide registration oversight. Pesticides are inspected and tested by the national food inspection and quarantine bureau.
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Circularity in Automobolies and EV
Voluntary Vehicle-Fleet Modernization Program
VVMP popularly known as India’s Scrappage Policy, 2021 is aimed at creating an eco-system for phasing out of unfit and polluting vehicles. The policy was introduced by Prime Minister Narendra Modi, at
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What are the main chemical regulations in Turkey?
The main chemical regulation in Turkey is KKDIK, which is an acronym in the Turkish language for Registration, Evaluation, Authorization and Restriction of Chemicals. KKDIK is also known as Turkey-REACH.
Kimyasalların (Chemicals)
Kaydı
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What are the tonnage band for the pre-registration/registration under Turkey-REACH?
Under Turkey-REACH, chemicals can be registered with following tonnage bands:
1-10 tons/ year
10-100 tons/ year
100-1000 tons/ year
1000+ tons/ year
In case the substance qualifies as an intermediate, the applicable tonnage bands
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What is the scope of Turkey-REACH / KKDIK?
Turkey REACH (KKDIK) regulates manufacturing, placing on the market or use of chemicals and chemicals in a mixture or in an article.
Enterprises have the obligation to comply with the KKDIK regulation via pre-registration and registration.
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What are the exemptions under Turkey REACH?
The following substances are exempted from Turkey REACH:
Radioactive substances and mixtures
Substances, on their own, in a mixture or in an article, which are subject to customs supervision, provided that they do not undergo any treatmen
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Who can register?
Turkish Manufacturers
Turkish Importers
Non-Turkish manufacturers can appoint an “Only Representative (OR)” to register on behalf of them, also taking over the registration responsibility from the importer.
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What are the documents needed for the pre-registration?
Companies can pre-register the substances by filling the pre-SIEF.
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What are the obligations of non-Turkish companies?
Non-Turkish companies that exporting substances to Turkey are not obliged to register unless they appoint an "Only Representative"(OR) to accomplish the obligations of importers.
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What is the role of an Only Representative (OR)?
Only Representatives (OR) are:
A natural person or legal entity established physically in TURKEY
Equipped with sufficient knowledge in the practical handling of the substances and information related to them (CICR/KEK, CLP/SEA, SDS/GBF,
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What are the differences between TII and Full registration?
Enterprises need to do TII registration if their registered chemicals are considered as intermediates. Buyers have to provide a declaration regarding the use of the chemical, often under strictly controlled conditions. Registrants can do self-decla
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How is tonnage calculated under Turkey-REACH?
The annual tonnage is calculated as the volume per manufacturer/importer per calendar year. For substances that have been imported/manufactured over the past three years consecutively, the tonnage is calculated as the mean of three years. For o
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Do substances used in biocides and plant protection products (PPP) have to be registered under Turkey-REACH?
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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Is Turkey-REACH applicable to chemical substance (as substance, in mixtures or in articles) with manufactured/imported tonnage below 1 ton per year?
Under Turkey-REACH, registrants have obligations regardless of tonnage.
These include restrictions, authorization and communication within supply chain (such as the provision of Safety Data Sheets). The one ton and above per year thresho
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Does Turkey-REACH regulate substances occurring in nature?
Yes, Turkey-REACH applies to substances occurring in nature, as defined by Article 4(h) of Turkey REACH. However, Annex V of Turkey REACH states that the following substances occurring in nature are exempted from registration if they are not chemi
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Do I have to register polymers?
According to Article 7 of Turkey REACH, polymers do not have to be registered, but the monomer substance(s) and other substances of the polymers that have not been registered by an actors within the supply chain, can be registered with followin
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What are the similarities and differences between Turkey REACH and EU REACH?
Items
EU-REACH
Turkey REACH
Registration Target
New substance (>=1T/Y); Existing Substance (>= 1T/Y)
All substances (>= 1T/Y) regardless phase
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What is the scope of application under K-REACH?
All chemical substances except the following are subject to K-REACH.
Radioactive material defined in subparagraph 5 of Article 2 of the Nuclear Safety Act;
Drugs defined in subparagraph 4 of Article 2 of the Pharmaceutical Affairs Act and
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Does the existing chemical that is used for cosmetics need pre-registration?
As per K-REACH Article 3(2), Cosmetics defined in subparagraph 1 of Article 2 of the Cosmetics Act and raw materials used for cosmetics are not subject to pre-registration.
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What is the definition of polymer under K-REACH?
The term "polymer" under K-REACH refers to chemical substances satisfying all the following requirements.
It shall be composed of molecules in which at least one kind of monomer unit is continuously repeated;
It shall represent the characteri
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Why do companies need to pre-register the existing chemicals?
According to the K-REACH Article 10, those who intend to manufacture or import more than one ton per year need to register substance. After pre-registration, companies can get a grace period that allows manufacturer and importer to continue their bus
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Do companies need to pre-register if the substances manufactured or imported is below 1 ton?
According to the K-REACH Article 10, a person who intends to manufacture and import a existing chemical substance more than one ton per year needs to register before manufacture or import. To get the grace period, the pre-registration is required. Ho
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Is it possible to manufacture and import without pre-registration?
No, pre-registration is necessary if a person has manufactured and imported the existing substance for more than 1 ton per year in 2016, 2017 and 2018. While proceeding the pre-registration, the person can continue to manufacture and import the conc
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After pre-registration deadline, can companies who intend to manufacture or import more than one ton per year get a grace period?
Those who intend to manufacture and import existing chemical substances more than one ton per year may be subject to the grace period after the pre-registration deadline (2019.6.30) once completing the late pre-registration. However, in order to fac
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Are new chemical substances subject to pre-registration?
New chemical substances are not subject to pre-registration. During the grace period, one must report (less than 100kg per year) or register (more than 100kg per year) before manufacture and import.
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What is the registration procedure when an overseas manufacturer and importer wants to appoint an OR?
Foreign manufacturers and producers can register through appointing an OR in accordance with Article 38 of the 「Act on Registration and Evaluation of Chemical Substances」.
When an importer imports more than 1 ton of registered chemical subst
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Who has an obligation to notify the chemical under Swiss Chemical regulation?
The new substances should be notified before placing into the market by
Swiss manufacturer,
Importer
Only Representative can notify the substances on behalf of Non Swiss Manufacturer
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Do I have to register finished cosmetic products?
As per the Official Guideline on Registration Heading 2.5.1 in KKDIK, the ingredients in the finished cosmetic products also need to be registered, as cosmetic products can be defined under the term "mixture" and ingredients of a mixture must be regi
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Global Product Compliance (GPC) specializes in Global Regulatory Compliance Solutions across sectors
globally. SSS Europe, a familiar name in chemical regulatory and compliance services now formally belongs
under the umbrella of GPC Holding Sweden.
Since 2008, we have emerged as one of the leading names among Global Regulatory Compliance Service
Providers with Representation services in Europe, Asia and Middle East for respective chemical
regulations.
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