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Regulations on New Chemical Substances Registration

  • Last Modify Date:2020-01-21

新化學物質登記管理辦法(民國 10408 19 日修正)

Regulations on New Chemical Substances Registration (2015.08.19 Modified)

第 一 章 總則

Chapter Ⅰ General Regulations

第 1

本辦法依職業安全衛生法第十三條第三項規定訂定之。

Article 1

These Regulations are promulgated according to Article 13, Paragraph 3 of the Occupational Safety and Health Act.

第 2

本辦法用詞,定義如下:

一、化學物質:指自然狀態或經製造過程所得之化學元素或化合物,包括

    維持產品穩定所需之任何添加劑,或製程衍生而非預期存在於化學物

    質中之成分。但不包括可分離而不影響物質穩定性,或改變其組成結

    構之任何溶劑。

二、登記人:指依本辦法規定,申請中央主管機關核准輸入或在國內製造

    新化學物質,並完成登記程序之廠商或機構。

三、天然物質:指未經加工或只經人力、重力、機械等作用,溶解於水、

    以水萃取、蒸氣蒸餾、浮力、加熱移除水分,或用任何方法從空氣中

    分離出,且未產生任何化學變化之物質、來自於生物體之大分子,或

    未經化學加工之天然聚合物。

四、混合物:指含二種以上不會互相反應之物質、溶液或配方。

五、成品:指製造過程中,已形成特定形狀之物品或依特定設計之物品。

六、聚合物:指符合下列條件之化學物質:

(一)由一種或多種類型之單體單元,按序列聚合成大分子之化學物質。

(二)由三個以上之單體單元,以共價鍵形式相連而成之分子,其在化學

      物質中之總重量百分比大於百分之五十,且分子量相同者之重量百

      分比小於百分之五十。

(三)分子量分布差異係因其單體單元數目之差異而造成。

七、百分之二規則之聚合物:指聚合物名稱以單體基礎式命名時,可選擇

    包括或不包括未滿重量百分之二之單體及反應體,且單體基礎式命名

    ,指聚合物名稱以其組成單體為基礎加以命名者。

八、中間產物:指於一連串化學反應程序中,部分化學反應程序之產物作

    為後續反應原料之化學物質。

九、限定場址中間產物:指在單一場所製造並消耗之中間產物。

十、雜質:指非預期而存在於化學物質中之成分,源自化學物質原料、反

    應過程中次要反應或不完全反應;化學物質中之不純物亦屬雜質。最

    終化學物質中出現之雜質,其為非刻意加入,亦不會增加該化學物質

    之商業價值。但單一雜質成分含量,不得超過該化學物質之重量百分

    之十,多重雜質成分總量,不得超過該化學物質之重量百分之二十。

十一、副產物:指在使用或儲存過程中,因環境變化發生化學反應而生成

      之化學物質。

十二、海關監管化學物質:指儲存於海關監管之碼頭專區、貨棧、貨櫃集

      散站、保稅倉庫、物流中心或自由貿易港區等,待出口之化學物質

      。

十三、科學研發用途:指在科學學術環境與控制條件下,執行之科學性實

      驗、教育、分析或研究等用途。

十四、產品與製程研發用途:指在試驗工廠產製試驗,用於發展生產程序

      或測試物質應用領域之過程,與產品開發或製程物質發展直接相關

      之研發過程。

十五、低關注聚合物:指經中央主管機關審查,並符合下列條件之一者:

  (一)聚合物之數目平均分子量介於一千至一萬道爾頓(Dalton)之間

        者,其分子量小於五百道爾頓之寡聚合物含量少於百分之十,分

        子量小於一千道爾頓之寡聚合物含量少於百分之二十五。

  (二)聚合物之數目平均分子量大於一萬道爾頓者,其分子量小於五百

        道爾頓之寡聚合物含量少於百分之二,且分子量小於一千道爾頓

        之寡聚合物含量少於百分之五。

  (三)聚酯聚合物。

  (四)不可溶性聚合物(InsolublePolymers)。

十六、致癌性、生殖細胞致突變性或生殖毒性物質第一級化學物質(簡稱

      CMR 物質第一級):指化學物質依國家標準 CNS15030 危害分類,

      具致癌物質第一級、生殖細胞致突變性物質第一級或生殖毒性物質

      第一級。

Article 2

The terms used in these Regulations are defined as follows:

1. Chemical Substance refers to a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any unintended constituent deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.

2. Registrant as used herein means a firm or an institute which obtains approval from the central competent authority to import, or domestically manufacture new chemical substances, and completes registration procedure.

3. Substance which Occur in Nature refers to a substance that is unprocessed, processed only by manual, gravitational, or mechanical means, by dissolution in water, by water extraction, by vapor distillation, by flotation, by heating solely to remove water, are extracted from air by any means, without producing chemical change in the substance; or large molecules from organisms, or polymers occurring in nature and not chemically processed.

4. Mixture refers to a mixture or a solution composed of two or more substances in which they do not react.

5. Article refers to a manufactured item formed to a specific shape or design during manufacture.

6. Polymer refers to a chemical substance that fits the following criteria:

A. A macro-molecular chemical substance consisting of molecules characterized by the sequence of one or more types of monomer units.

B. A molecule contains at least three monomer units covalently bound; such molecules take over 50% of the weight of that substance, and the amount of the said molecules presenting the same molecular weight must be less than 50% of the weight of that substance.

C. Differences in the molecular weight are primarily attributable to differences in the number of monomer units.

7. Polymer for which the 2% Rule is Applicable refers to the monomer-based representation of polymers which may include or may not include monomers and other reactants used at 2 weight percent or less. A monomer-based representation means naming of polymers is based on constituent monomers.

8. Intermediate refers to a chemical substance produced and consumed in the course of the manufacture of another chemical substance.

9. On-site Isolated Intermediate refers to an intermediate that is produced and consumed on the same site.

10.Impurity refers to an unintended constituent present in a substance as produced. It originates from the starting materials or is the result of secondary or incomplete reactions during the production process. While it is present along with the final substance it was not intentionally added, nor does it enhance the commercial value of that substance. The concentration of an individual impurity is no more than 10% (w/w). All impurities presented are no more than 20% (w/w).

11.Incidental Reaction Products refer to chemical substances produced when a substance undergoes a chemical reaction that is consequent to the use of the substance, the result of storage or the change of environmental factors

12.Substance under Customs Supervision refers to a chemical substance under customs supervision, which is in temporary storage or placed in a harbor's designated area or warehouse, container freight station, bonded warehouse, logistics center or free trade zone, with a provision for re-exportation or transit

13.Scientific Research and Development refers to any scientific experimentation, education, analysis, or chemical research carried out under strictly controlled conditions.

14.Product and Process Orientated Research and Development (PPORD) refers to any scientific development related to product development or the further development of a substance, in the course of which pilot plant or production trials are used to develop the production process or to test the fields of application of the substance.

15.Polymer of Low Concern (PLC) refers to a substance that is evaluated by the central competent authority, and fulfills any one of the following conditions:

A. A polymer with an average molecular weight in a range of 1,000 to 10,000 Daltons, contains oligomers of molecular weights below 500 Daltons in amount of less than 10%; oligomers below 1,000 Daltons in amount of less than 25%.

B. A polymer with an average molecular weight over 10,000 Daltons, contains oligomers of molecular weights below 500 Daltons in amount of less than 2%; oligomers below 1,000 Daltons in amount of less than 5%.

C. Polyester polymers.

A. D. Insoluble polymers.

16. "Substance of Carcinogenic, Mutagenic or Toxic for Reproduction, CMR, Category 1" (hereinafter "CMR substance, Category 1") refers to a substance that meets any criteria of carcinogenicity category 1; mutagenicity category 1; reproductive toxicity category 1, based on R.O.C. National Standards CNS 15030.

第 3

中央主管機關公告於資訊網站之化學物質清單(以下簡稱公告清單)以外

之新化學物質屬下列性質者,不適用本辦法:

一、天然物質。

二、伴隨試車之機械或設備之化學物質。

三、於反應槽或製程中正進行化學反應且不可分離之中間產物。

四、涉及國家安全或國防需求之化學物質。

五、無商業用途之副產物或雜質。

六、海關監管之化學物質。

七、廢棄物。

八、已列於公告清單適用百分之二規則之聚合物。

九、混合物。但其組成之化學物質為新化學物質者,不在此限。

十、成品。

十一、其他經中央主管機關指定公告者。

Article 3

These Regulations shall not apply to a new chemical substance, which is excluded from the inventory of chemical substances announced on an information web site by the central competent authority(hereinafter "the announced inventory") and meets any of the following conditions:

1. Substances which occurred in nature.

2. Chemical substances accompanied in the machines or equipment for test-run purpose.

3. Inseparable intermediates from the chemical reaction in the reaction vessel or production process.

4. Chemical substances for national defense purpose

5. By-product or impurity that is of no commercial application.

6. Chemical substances under customs supervision.

7. Waste

8. A polymer that the 2% rule is applicable and is listed on the announced inventory

9. Mixtures. Exemption is not applicable to a mixture composed of new chemical substances. .

10.Articles

11.Others that have been designated and officially announced by the central competent authority

第 4

新化學物質依其用途,其他目的事業主管機關已訂有許可及管制規定者,

不適用本辦法。

Article 4

These regulations shall not apply to a new chemical substance, which according to its use is subjected to permit and control regulations promulgated by other government authorities in charge of subject industry.

第 二 章 核准登記及安全評估報告

Chapter Ⅱ Registration Approval and Safety Assessment Reports

第 5

製造者或輸入者對於公告清單以外之新化學物質,未向中央主管機關繳交

化學物質安全評估報告(以下簡稱評估報告),並經核准登記前,不得製

造或輸入含有該物質之化學品。

前項製造者或輸入者,得委託國內之廠商或機構,代為申請核准登記。

第一項公告清單之化學物質,中央環境保護主管機關依毒性化學物質管理

法另有規定者,從其規定。

Article 5

For a new chemical substance that is not listed in the announced inventory, manufacturers or importers shall not manufacture or import any chemicals containing such new chemical substance prior to submitting a chemical safety assessment report (hereinafter referred to as "assessment report") to the central competent authority and receiving registration approval for the new substance.

The manufactures or importers pursuant to the previous paragraph may appoint a domestic company or institute, as a representative to apply for registration approval.

But if Toxic Chemical Substances Control Act of the central authority in charge of environmental protection has otherwise provision governing chemical substances listed in the announced inventory pursuant to paragraph 1, the provisions of that act shall prevail.

第 6

製造者或輸入者應依其新化學物質之登記類型,按中央主管機關所定之技術指引及登記工具,繳交評估報告,申請核准登記。前項申請核准登記之類型及應繳交評估報告之資訊項目及內容如下:一、標準登記,如附表一。二、簡易登記,如附表二。三、少量登記,如附表三。前項新化學物質屬簡易登記、少量登記或經中央主管機關公告者,其製造者或輸入者已依毒性化學物質管理法取得中央環境保護主管機關核准登錄,得免依第一項規定申請核准登記。

Article 6

Manufactures or importers, to apply for registration approval, shall submit assessment reports according to the guidance and registration tools designated by the central competent authority, based on the registration type of the new chemical substance.

Registration approval types and the content required for assessment reports submitted are as follows:

1.Standard registration as specified in Appendix 1.

2.Simplified registration as specified in Appendix 2.

3.Small quantity registration as specified in Appendix 3.

The aforementioned new chemical substances belonging to simplified registration, small quantity registration, or are designated by the central competent authority may be exempted from the requirement to apply for registration approval of Paragraph 1 if the manufacturers or importers have obtained the registration approval by the central authority in charge of environmental protection, in accordance with the Toxic Chemical Substances Control Act.

第 7

製造者或輸入者申請前條新化學物質核准登記,應依附表四之年製造或輸

入量,選擇登記類型。

前項新化學物質符合下列情形之一者,得依附表五之年製造或輸入量,選

擇登記類型:

一、科學研發用途。

二、產品與製程研發用途。

三、限定場址中間產物。

四、聚合物或低關注聚合物。

申請前項第四款低關注聚合物之核准登記者,應於事前向中央主管機關提

出審查申請,並取得符合第二條第十五款所定條件之確認文件。

中央環境保護主管機關依毒性化學物質管理法審定為低關注聚合物者,於

其申請核准登記時,得免前項規定之文件。

Article 7

A manufacture or importer applying for new chemical substances registration approval, pursuant to the previous article shall select the type of registration depending on its annual manufactured or imported quantity as specified in Appendix 4.

For a new chemical substance pursuant to the previous paragraph and conforming to the following conditions, its registration type may be selected depending on its annual manufactured or imported quantity as specified in Appendix 5.

1. A substance used for Scientific Research and Development

2. A substance used for Product and Process Orientated Research and Development, PPORD

3. On-site Isolated Intermediates

4. Polymers or Polymers of Low Concern (PLC)

A registrant applying for registration approval of Polymer of Low Concern pursuant to subparagraph 4 of the previous paragraph, shall submit prior verification application to the central competent authority and obtain confirmation document in compliance with Article 2, subparagraph 15.

Required documentsofthe preceding Paragraph may be exempted if the substance has been verified as PLC by the central authority in charge of environmental protection in accordance with the Toxic Chemical Substances Control Act.

第 8

依前二條規定申請核准登記之新化學物質,符合簡易登記及少量登記類型

者,經確認該新化學物質屬CMR物質第一級時,中央主管機關得要求申請人

依標準登記之規定辦理。

Article 8

For a new chemical substance that satisfies the conditions to apply for registration approval using simplified registration or small quantity registration pursuant to the previous two Articles, the central competent authority may subject the applicant to apply the provisions for standard registration if the substance is identified as a substance of CMR, category 1.

第 9

新化學物質符合科學研發用途、產品與製程研發用途或經中央主管機關指

定公告者,申請人除使用登記工具繳交評估報告外,應另繳交中央主管機

關指定之相關資料。

Article 9

For a new chemical substance fulfilling the criteria of the substances used for the purpose of Scientific Research and Development, or for Product and Process Orientated Research and Development; or designated and announced by the central competent authority, its assessment reports shall be filed through registration tools by the applicant. In addition, relevant information designated by the central competent authority shall be submitted as well.

第 10

二個以上製造者或輸入者申請登記相同之新化學物質時,得共同申請核准

登記,其化學物質總量合併計算。

申請人對於中央主管機關已核准登記之新化學物質,得經原登記人同意,

於核准登記文件所載有效期間內,向中央主管機關申請核准共同登記。

前項共同登記,其登記文件之核發日期與有效期間,應與原登記文件所記

載者相同,但須加註變更為共同核准登記之日期,且共同核准登記之物質

總量合併計算。

相同之新化學物質全國之年製造或輸入合計達一定數量者,中央主管機關

得指定變更登記類型或指定進行共同核准登記。

Article 10

Two or more manufactures or importers applying for registration for the same new chemical substance may jointly submit application for registration approval. Quantities shall be aggregated for all substances approved under joint submission.

For a new chemical substance granted under registration approval by the central competent authority, with consent of the original registrant, an applicant may apply to the central competent authority for joint registration approval, within the valid period of the registration approval document.

Issue date and valid period of the registration document granted under joint registration, pursuant to the previous paragraph, shall remain the same as the original registration document. But the date on which above modification to the joint registration approved shall be noted; that the type of registration according to the aggregated quantities under joint registration shall be noted, as well.

The central competent authority may subject new chemical substances to certain registration type or joint submission where the national annual manufactured or imported quantity of the same new chemical substance reaches certain amount.

第 11

本辦法施行前製造或輸入之新化學物質,製造者或輸入者得檢具製造或輸

入該新化學物質之證明文件,自中華民國一百零四年一月一日起至一百零

四年三月三十一日止之期間,向中央主管機關申請核准登記,並依附表六

繳交評估報告,不受第六條及第七條規定之限制。

前項核准登記文件之有效期間為一年,期滿不得展延。

Article 11

For a new chemical substance that is manufactured or imported before these Regulations take effect, from January 1st, 2015 to March 31st, 2015, manufactures or importers may apply to the central competent authority for registration approval by attaching documents evidencing its manufacture or importation and assessment reports as specified in Appendix 6.

This new chemical substance shall not be subject to the restriction of Article 6 or Article 7.

The aforementioned registration approval document is valid for one year, which shall not be extended upon expiration.

第 12

自本辦法施行日起至中華民國一百零四年十二月三十一日止,製造或輸入

之新化學物質,製造者或輸入者得於該期限內依少量登記類型,繳交評估

報告,申請核准登記,不受第六條及第七條規定之限制。

前項核准登記文件之有效期間為一年,期滿不得展延。

Article 12

For a new chemical substance manufactured or imported during the period from the effective date of these Regulations to December 31st, 2015, the manufacturer or importer may apply for registration approval within the aforementioned period, along with assessment reports, according to the requirement of small quantity registration. This new chemical substance shall therefore be not subjected to the restriction of Article 6 or Article 7.

The aforementioned registration approval document is valid for one year, which shall not be extended upon expiration.

第 三 章 審查程序

Chapter Ⅲ Review Procedures

第 13

申請人申請核准登記之文件,有下列情形之一者,中央主管機關得不予受

理或原件退還:

一、未依中央主管機關指定之登記工具或表單提交登記資料。

二、未依申請收費標準繳費。

Article 13

The central competent authority may refuse or reject an application, if document sent for application of registration approval by the applicants meets any of the following circumstances:

1. The registrant fails to submit information through registration tool designated by the central competent authority, or fill out corresponding forms

2. Registration fees are failed to be paid according to the application fee standard.

第 14

中央主管機關,應就申請人申請核准登記之文件,實施審查。

前項審查,中央主管機關得邀集相關專業領域之專家學者,組成審查小組

辦理之。

Article 14

The central competent authority shall review the document sent for registration approval application by an applicant.

For the review procedure pursuant to the previous paragraph, the central competent authority shall invite experts and scholars specialized in relevant fields, and set up a review panel.

第 15

中央主管機關審查評估報告,認其資料有誤或不足者,得要求申請人補正。

申請人應於要求補正通知書送達之日起三十個工作天內完成補正,逾期未

補正者,視同審查未通過。

前項補正次數,以二次為限。

Article 15

The central competent authority shall review assessment reports; should the review procedure finds that information mistaken or inadequate, the central competent authority shall require the registrant to make supplementation and correction.

The applicant shall make supplementation and correction within 30 working days of receiving the notification of supplementation and correction.

Registration review shall be deemed not approved if the registrant fails to make supplementation and correction within the allotted time. Correction and supplementation pursuant to the previous paragraph shall only be made no more than twice.

第 16

申請人對於登記審查結果有疑義者,得於審查結果通知送達之日起三十個

工作天內,以書面敘明理由申覆。

前項申覆次數,以一次為限。

Article 16

If an applicant has any concerns regarding the result of registration review, written appeal with stated reasons may be submitted within 30 working days after receiving the notification of review results.

The appeal pursuant to the previous paragraph shall be made once only.

第 17

申請人使用申請登記工具所檢附之文件及核准登記文件,應保存五年。

Article 17

An applicant shall keep all the documents submitted through registration tools and the registration approval document for five years.

第 18

中央主管機關得委託相關專業團體,辦理新化學物質之核准登記作業。

Article 18

The central competent authority may commission related professional organizations to carry out procedures of new chemical substances registration approval.

第 19

申請人繳交之評估報告,經檢視符合規定並經審查合格後,中央主管機關

應核發核准登記文件。

Article 19

The central competent authority shall issue registration approval document where assessment reports submitted by an applicant meet applicable requirements after review.

20

新化學物質之核准登記文件,應記載下列事項:

一、登記人基本資料。

二、新化學物質編碼。

三、核准登記類型。

四、核發日期及有效期間。

Article 20

The following items shall be specified in the a registration approval document:

1. Registrant basic information

2. New chemical substance serial number

3. Approved registration type

4. Document issue date and valid period

第 四 章 核准登記之管理

Chapter Ⅳ Management of Registration Approval

21

登記人供應鏈之廠商,需前條核准登記文件證明者,登記人應提供其前條

第二款至第四款所記載之資訊。

Article 21

A registrant shall provide information specified pursuant to subparagraph 2 to 4 of the previous article, if his supply chain companies require the proof of registration approval document.

22

中央主管機關依登記類型發給核准登記文件之有效期間如下:

一、標準登記:五年。

二、簡易登記:二年。

三、少量登記:二年。但少量登記之低關注聚合物之有效期間為五年。

前項簡易登記、少量登記之核准登記文件有效期間屆滿前三個月,登記人

得申請展延,經審查後發給新登記文件。

Article 22

The valid periods of the registration approval documents issued by the central competent authority are as follows:

1. Standard registration: 5 years;

2. Simplified registration: 2 years;

3. Small quantity registration: 2 years. However, valid period of Polymers of Low concern granted under small quantity registration is 5 years.

An application of registration approval document extension for simplified registration and small quantity registration pursuant to the previous paragraph may be made by registrants three months before the expiration of the registration approval document. New registration approval document shall be issued after review.

23

新化學物質於核准登記文件之有效期間內,登記人基本資料有異動者,應

於異動後三十個工作天內,檢具相關文件向中央主管機關辦理變更。

新化學物質之登記類型與原登記文件不符時,登記人應依第六條及第七條

規定,重新申請登記並繳交評估報告。

Article 23

For a new chemical substance, which registration approval document is within valid period, a registrant shall apply for modification of registration document by attaching related documents within 30 working days after any changes to basic information related to a registrant.

If the registration type of a new chemical substance is different from the original registration approval document, the registrant shall make a new registration application and submit assessment reports in compliance with Article 6 and Article 7.

24

經核准登記之新化學物質,有下列情形之一者,登記人應主動或依中央主

管機關之要求,提出補充資訊:

一、發現有新危害證據或新資訊。

二、發現有新用途。

三、其他經中央主管機關指定公告者。

Article 24

For a new chemical substance granted under registration approval having any of the following circumstances, the registrant shall provide supplementary information initiatively or as prescribed by the central competent authority.

1. New scientific evidence or information on chemical substances is discovered.

2. New use is discovered.

3. Other matters designated by the central competent authority through public announcement.

25

登記人取得新化學物質核准登記文件後,有下列情形之一者,中央主管機

關得撤銷或廢止其核准登記:

一、經查核確認登記人無適當措施管理新化學物質,經通知限期改善,屆

    期未改善。

二、登記人繳交之評估報告內容不實,或未依核准登記事項辦理。

三、登記人歇業或經目的事業主管機關撤銷、廢止其工商登記或學術機構

    證明文件。

四、未依前二條規定辦理登記文件變更或未依中央主管機關要求提出補充

    資訊,經通知限期改善,屆期未改善。

登記人經撤銷或廢止登記後,二年內不得再申請該新化學物質之核准登記。

Article 25

If a registrant who obtained a new chemical substance registration approval document is found to have any of the following circumstances, the central competent authority may void or revoke their registration approval:

1. A registrant is confirmed by an inspection that no appropriate measures are employed to manage the new chemical substance, and has been notified to make improvements within a limited time period, but fails to do so.

2. A registrant submits assessment reports containing false information or fails to perform handling in accordance with approved items under registration.

3. A registrant no longer operates business, or his documents certifying industrial/commercial registration or the academic institutes have been voided or revoked by authorities in charge of subject industry.

4. A registrant fails to make registration document modification pursuant to the previous two articles or has been notified by the central competent authority to provide supplementary information within a limited time period, but fails to do so.

Once the registration approval has been voided or revoked, a registrant is not allowed to make another new application of new chemical substances registration approval within two years.

26

為預防新化學物質嚴重危害工作者健康,必要時,中央主管機關得廢止登

記人之核准登記文件、縮短登記有效期間,或依其危害風險,公告限制其

運作方法或用途。

Article 26

To avoid severe endangerment of workers health by a new chemical substance, if necessary, the central competent authority may revoke registration approval document, shorten valid period of registration, or according to its risk of hazards, restrict handling methods or use through public announcement.

第 五 章 資訊公開及其他應遵循事項

Chapter Ⅴ Supplementary Provisions

27

中央主管機關審查申請人檢送之評估報告後,得公開化學物質之下列資訊:

一、新化學物質編碼。

二、危害分類及標示。

三、物理及化學特性資訊。

四、毒理資訊。

五、安全使用資訊。

六、為因應緊急措施或維護工作者安全健康,有必要揭露予特定人員之資訊。

前項第六款之資訊範圍如下:

一、新化學物質名稱及基本辨識資訊。

二、製造或輸入新化學物質之數量。

三、新化學物質於混合物之組成。

四、新化學物質之製造、用途及暴露資訊。

Article 27

The central competent authority may disclose the following information after reviewing assessment reports submitted by an applicant:

1. New chemical substance serial number

2. Hazard classification and labelling

3. Physical and chemical properties

4. Toxicological information

5. Safe use information

6. Necessary information disclosures to special personnel required for the purpose of protecting workers safety and health, or emergency measures.

Contents scope subject to subparagraph 6 of the previous paragraph are as follows:

1. Name and basic identification of a new chemical substance;

2. Manufactured or imported quantity of a new chemical substance;

3. The percentage composition of the new chemical substance in a mixture;

4. Manufacture, use and exposure information of a new chemical substance.

28

符合下列規定之新化學物質,中央主管機關得列入公告清單:

一、標準登記滿五年者。

二、少量登記滿五年且屬於低關注聚合物者。

三、依附表一標準登記資訊要求,並繳交危害評估資訊及暴露評估資訊,

    經登記人申請提前列入清單者。

四、少量登記且屬於低關注聚合物,經登記人申請提前列入清單者。

Article 28

A new chemical substance in any one of following circumstances may be announced and included in the announced inventory by the central competent authority.

1. It is full five years after standard registration process is filed and completed.

2. It is full five years after a PLC has been granted under small quantity registration. .

3. The standard registration has been filed through submission of information on hazard assessment and exposure assessment, as specified in Appendix 1, while an application for substance early inclusion on the announced inventory is submitted by the registrant.

4. For a PLC granted under small quantity registration, an application has been made for early inclusion on the announced inventory.

29

前條之新化學物質,登記人有下列情形之一,且須保留化學物質名稱者,

得於列入公告清單前三個月至六個月向中央主管機關申請資訊保護:

一、要求保護之化學物質屬於登記人之商業機密。

二、登記人已採取行動,並將持續維持化學物質之保密性。

三、物質名稱除登記人同意外,尚未被第三者以合理且合法之管道取得。

前項申請經核准者,有效期間為五年,登記人得於有效期間屆滿前三個月

申請展延一次。

Article 29

A registrant of a new chemical substance pursuant to the previous article, who meets any one of the following conditions and requests substance name to be kept confidential, shall apply for information protection, three to six months before the substance is included in the announced inventory.

1. The substance name subjected to protection contains business secret of the registrant.

2. The registrant has taken actions and will remain the confidentiality of substance name.

3. The substance name has not been accessed by the third party through reasonable and legitimate approach unless otherwise authorized by the registrant.

A valid period of an approved application pursuant to the previous paragraph is five years.

Three months before the expiration of information protection, the registrant may request extension once for another 5 years.

第 六 章 附則

Chapter Ⅵ Supplementary Provisions

30

中央主管機關對於本辦法所定申請新化學物質核准登記案件之受理、審查

及核發許可文件之程序,得會商中央環境保護主管機關辦理之。

Article 30

Any matter with respect to acceptance and review of an application of new chemical substances registration approval, as well as the issuance procedure of registration approval document, prescribed in these Regulations, may be handled by the central competent authority in consultation with the central authority in charge of environmental protection.

31

本辦法自中華民國一百零四年一月一日施行。

本辦法修正條文自發布日施行。

Article 31

These Regulations shall take effect on January, 1st, 2015.

Amendments to these Regulations shall take effect from the date of promulgation.



  • Publish Date:2019-01-28
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