On March 24, 2023, the Taiwanese Environmental Protection Administration (EPA) released the Guidance on Phrase 1 Registration of New and Existing Chemical Substances (Version 1) (hereinafter referred to as the “Guidance”).
The Guidance aims to explain relevant provisions of the Regulation of New and Existing Chemical Substances Registration to help registrants complete registrations. Earlier in August 2015, Taiwan’s EPA implemented the Guidelines for the Registration of New and Existing Chemical Substances (hereinafter referred to as the "Guidelines"). In the past eight years, many problems have been encountered and some testing standards have also been updated. Considering these problems and the increasing suggestions from the industry, Taiwan’s EPA hereby made the revisions.
There are five chapters in the Guidance and details are listed in the following：
Guidance on Phrase 1 Registration of New and Existing Chemical Substances (Version 1)
Overview of Registration: To help enterprises grasp the key points of registration, this chapter introduces the legal basis, application method of registration tools, the definition of registration, and registration deadlines.
Scope of Registration: This chapter clearly defines the registration scope, time, existing chemical inventory, qualifications of registration personnel, and registration scope of substances to help registrants identify registration type.
Registration Type and Information Required: Registration type and information required for registration are stipulated and conditions of application for different registrations are specified.
Registration Process and Information System: This chapter provides instructions on the registration tools to guide companies make registrations by following the designated registration tool, platforms, and forms.
Data Review, Data Management, and Information Disclosure: This chapter describes the process and management of chemical substance registration review, and the principles of information disclosure.
In this chapter, the identification and naming principle of new chemical substances are stipulated; the inventory of polyester reactants for low-concern polymers is provided; the table of hazardous substances category; the identification criteria of PBT and vPvB substance are stipulated; examples of nanomaterials and authorization letter are provided.
What are the highlights of the revised Guidance? What should enterprises do when confronted with this situation? Here we at CIRS Group have made a thorough analysis and research with our professional team:
1) Requirements for Phase 1 registration of existing chemicals have been adjusted
From April 1, 2016, if the annual amount of existing chemicals manufactured or imported for the first time exceeds 100 kilograms, registration approval should be obtained within six months from the date of manufacturing or importing. If the annual amount is below 100 kilograms, registration can be made in advance.
Enterprises must obtain the registration approval code within six months if the annual amount of existing chemicals manufactured or imported exceeds 100 kilograms for the first time since April 1, 2016. If the annual amount is below 100 kilograms, enterprises must make applications before manufacture or importation.
CIRS reminds you that if enterprises intend to manufacture or import existing chemicals in large quantities, they should make phase 1 registration in advance to avoid delaying standard registration.
2) The requirements and validity period for the letter of authorization have been adjusted
A signature and the company seal of the entrusting party are only required in the letter of authorization with a long validity period. Therefore, it is not necessary for enterprises to frequently sign the LOA with agents.
3) Definition of some chemical substances has been added
If an enterprise independently manufactures or imports substances such as antioxidants, heat stabilizers, or light stabilizers to maintain chemical stability, it shall complete corresponding registrations as required.
Registration requirements have been added for certain types of chemical substances. Therefore, enterprises that intend to independently manufacture or import these substances should complete the necessary registrations as required.
4) Requirements for registrations of mixtures have been added
It is worth mentioning that mixtures as a whole do not need to make registrations. However, individual chemical substances in the mixture should be registered. Moreover, hydrates and alloys are also classified as mixtures. If hydrates and alloys themselves have unique characteristics or properties, they may be registered separately.
As mentioned earlier, mixture registration has been added. If there are individual chemicals in imported mixtures, then registrations must be made for these individual chemicals. Registration types of mixtures are further clarified to help enterprises identify mixtures and make corresponding registrations.
5) Article 4 of the identification of polymers of low concern (PLC) has been adjusted
In Article 4 of the identification of PLC, designated solvents are adjusted into two kinds including tetrahydrofuran and N,N-Dimethylformamide, which means the identification of PLC is lowered and registration is much easier.
6) The scope of exemptions has been expanded
Proteins and other macromolecules generated through genetic regulation are classified as natural substances; mixtures that are added to household packages are considered finished products. These substances do not need registrations.
7) Requirements for toxicological and ecotoxicological test reports have been adjusted
Scientific literature has been removed from the toxicological and ecotoxicological test reports since international journal literature is not accepted for new chemical substance registrations.
8) Toxicology test requirements and submission of test documents have been adjusted
When the test results of in vitro skin irritation are positive, an in vitro skin corrosion test should be further performed. When the test results of in vitro skin corrosion are positive, an in vitro skin irritation test should be further performed. When hazard classification can be identified based on in vitro test results or SAR, in vivo skin irritation/corrosion tests can be exempted. When hazard classification can be identified based on the results of in vitro eye irritation test, SAR or read-across, in vivo eye irritation tests can be exempted. In addition, in vitro skin sensitization tests are added; circumstances that need 90-day repeated dose toxicity tests for phrase 2 registration substances are added; circumstances that need chronic repeated toxicity tests for phrase 3 or 4 registration substances are added; genotoxicity and basic toxicokinetics are adjusted correspondingly. Therefore, enterprises should conduct corresponding tests based on the above test requirements and registration types of substances to successfully obtain approval and make registrations.
9) Toxicological and ecotoxicological test specifications have been added
Recommended testing standards
In vitro test
OECD TG 460
OECD TG 491
OECD TG 492
OECD TG 494
OECD TG 496
OECD TG 467
In vitro test
OECD TG 497
OECD TG 442C
OECD TG 442D
OECD TG 442E
In vitro mammalian cell genotoxicity test
OECD TG 490
In vivo gene
OECD TG 489
Toxic effect on terrestrial plants
Lowest Observed Effect Concentration (LOEC)
OECD TG 227
No Observed Effect Concentration (NOEC)
Bioaccumulation: aquatic organisms/sediments.
OECD TG 305-I
OECD TG 305-II
OECD TG 305-III
Test standards for eye irritation, skin sensitization, genotoxicity, toxicity to terrestrial plants, bioaccumulation: aquatic organisms/ sediments have been added. Attention should be paid to the in vitro test for skin sensitization which has been newly added to give enterprises more options.
10) Exemption conditions for physical and chemical properties and toxicity testing have been added
New exemption provisions
(Kow) n-octanol/water partition coefficient
If testing cannot be conducted due to substance decomposition, high surface activity, severe reactions during testing, insolubility in water or octanol, estimated values of Kow and the estimation method or software should be provided.
Metal or metal compounds with limited solubility; Information on the conversion/dissolution of the substance in water shall be provided; if a substance is insoluble in water, limited tests of quantitative analytical method should be performed.
（2）Solids that are not flammable and have a steam pressure of less than 1hPa.
Other substances that do not undergo exothermic reactions with combustible materials, with sufficient supporting evidence provided.
(1) Gas; and
(2) Hydrocarbons; under this circumstance, data on kinematic viscosity at 40℃shall be provided.
Solid with a melting point of not less than 55℃.
Substances that are flammable in contact with water at room temperature (e.g. Non-aqueous substances) can be exempted. However, QSAR and/or read-across shall be further considered for hazard prediction.
If a substance is already classified as a category 1A or 1B carcinogen, or it is classified as category 1A, 1B, or 2 of germ cell mutagenicity, then this substance can be exempted from in vitro mammalian cell gene mutation test.
Repeated dose toxicity: oral, dermal, inhalation
If the 28-day repeated dose toxicity test of a substance is classified as category 1, then this substance can be exempted from the 90-day repeated dose toxicity test.
If the reproductive toxicity of a substance is classified as a category 1A or 1B, then this substance can be exempted from reproductive or developmental toxicity tests under certain conditions.
Considering the expensive testing costs for new chemical substance registration, the above-mentioned new exemption provisions can ease the economic pressure on registrants to some extent and help companies complete registrations with lower costs.
11) An extension for submitting supplementary materials has been added
If supplementary materials or corrections have not been submitted within the deadline because of scientific or technological factors, then applicants can apply for an extension. If the supplementary materials are still not submitted or corrections are still not made when the correction times reaches two, then the application will be rejected. The Guidance stipulates provisions for a correction deadline extension, which will help companies to complete registrations within the deadline.
12) Time to change the responsible person has been added
A request to change the responsible person should be submitted within 60 working days during the validity period of the chemical substances registration code.
In addition to the above changes, the Taiwanese EPA also made revisions and integrations to certain provisions, statements, and appendices of the Guidance.
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