On March 24, 2023, 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 are explained to help registrants complete relevant registrations. Earlier in August 2015, Taiwanese EPA implemented the Guidelines for the Registration of New and Existing Chemical Substances (hereinafter referred to as the "Guidelines"). In the past 8 years, many problems have been encountered and some testing standards have also been updated. Considering these problems and increasing suggestions from the industry, Taiwan’s EPA hereby made the revision.
There are five chapters in the Guidance, and details on the Guidance are listed in the following:
| Guidance on Phrase 1 Registration of New and Existing Chemical Substances (Version 1) | |
| Chapter I | Overview of Registration: To help enterprises grasp the key points of registration, this chapter introduces the legal basis, application method of registration tools, definition of registration, and registration deadlines. |
| Chapter II | 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. |
| Chapter III | Registration Type and Information Required: Registration type and information required for registration are stipulated and conditions of application for different registrations are specified. |
| Chapter IV | 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. |
| Chapter V | Data Review, Data Management, and Information Disclosure: This chapter focuses on describing the process and management of chemical substance registration review, and the principles of information disclosure. |
| Appendix | In this chapter, 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 amended Guidance? What should enterprises do when confront with this situation? Here we make a thorough analysis and research:
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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 or more, registration approval should be obtained within 6 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 6 months if the annual amount of existing chemicals manufactured or imported exceeds 100 kilograms in the first time from April 1, 2016. If the annual amount is below 100 kilograms, enterprises shall make applications before manufacture or importation.
We remind you that if enterprises intend to manufacture or import existing chemicals in large quantities later, they should make phase 1 registration in advance to avoid delaying standard registration.
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The requirements and validity period for the letter of authorization have been adjusted;
Signature and the company seal of the entrusting party are only required in the authorization letter with long validity period. Therefore, it is not necessary for enterprises to frequently sign authorization letter with agents and workload is reduced.
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Definition of 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. Enterprises should complete corresponding registrations as required if they intend to independently manufacture or import these substances.
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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 classified as mixtures. If hydrates and alloys themselves have unique characteristics or properties, they may be registered separately.
As mentioned earlier, mixture registration is added. If there are individual chemicals in imported mixtures, then registrations shall be made for these individual chemicals. Attention shall also be paid to hydrates and alloys since they are considered as mixtures. If hydrates and alloys have unique characteristics or properties, they can be registered separately. In a word, registration types of mixtures are further clarified to help enterprises identify mixtures and make corresponding registrations.
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Article 4: identification of polymers of low concern (PLC) has been adjusted;
In Article 4 of identification of PLC, designated solvents are adjusted into 2 kinds including tetrahydrofuran and N,N-Dimethylformamide, which means the identification of PLC is lowered and registration is much more easier.
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The scope of exemptions has been expanded;
Proteins and other macromolecules generated through genetic regulation are classified as natural substances and mixtures added into household packages are considered as finished products. These substances do not need registrations.
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Toxicological and ecotoxicological test reports have been adjusted;
Scientific literature shall be removed from the toxicological and ecotoxicological test reports since international journal literature is not accepted for new chemical substances.
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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 level 2 registration substances are added; circumstances that need chronic repeated toxicity tests for level 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.
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Toxicological and ecotoxicological test specifications have been added;
Items Testing/Evaluation Endpoint Recommended Testing Standards Eye irritation In vitro test OECD TG 460
OECD TG 491
OECD TG 492
OECD TG 494
OECD TG 496
OECD TG 467Skin sensitization In vitro test OECD TG 497
OECD TG 442C
OECD TG 442D
OECD TG 442EGenotoxicity 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 Bioaccumulation factor (BAF) OECD TG 305-I
OECD TG 305-II
OECD TG 305-IIITest standards for eye irritation, skin sensitization, genotoxicity, toxicity to terrestrial plants, bioaccumulation: aquatic organisms/ sediments have been added. Attention shall be paid to in vitro test for skin sensitization which is newly added to give enterprises more options.
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The exemption for physical and chemical properties and toxicity testing have been added;
| Testing Items | New Exemption Provisions |
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(Kow) n-octanol/water partition coefficient |
If testing can't be conducted due to substance decomposition, high surface activity, severe reactions during testing, insolubility in water or octanol, etc., Estimated values of Kow and the estimation method or software should be provided. |
| Water solubility | 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, limit tests of quantitative analytical method should be performed. |
| Flash point |
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| Oxidizability | Other substances that do not undergo exothermic reactions with combustible materials, with sufficient supporting evidence provided. |
| Viscosity |
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| Metal corrosion | Solid with a melting point of not less than 55℃ |
| Skin irritation | 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. |
| Eye irritation | |
| Skin sensitization | |
| Genotoxicity |
If a substance is already classified as 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 90-day repeated dose toxicity test. |
| Reproductive/developmental toxicity |
If the reproductive toxicity of a substance is classified as category 1A or 1B, then this substance can be exempted from reproductive or developmental toxicity test under certain conditions. |
Considering the expensive testing cost 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.
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Extension time for submitting supplementary materials have been added;
If supplementary materials or correction have not been submitted within the deadline because of scientific or technological factors, then applicants can apply for an extension time. 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 correction deadline extension, which will help companies to complete registrations within deadline.
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Time for changing the responsible person has been added;
Request for changing the responsible person should be submitted within 60 working days during the validity period of chemical substances registration code.
In addition to the above changes, Taiwan EPA also made revision and integration to certain provisions, statements, and appendix of the Guidance.
To help enterprises better understand the changes of the amended Guidance on Phrase 1 Registration of New and Existing Chemical Substances in Taiwan and to grasp relevant requirements, we are scheduled to hold a webinar on April 27th, aiming to provide regulatory interpretation and compliance advice to enterprises involved. Welcome all of you to attend our webinar.
