- 1 - 
Regulation of New Chemical Substances Registration (Draft) 
ሯ೮া၍ 理ࣩ  
1. Definition
່  z ʘf
z ሯʘ೮া 類e類йe年量ሯτΌ൙Пజѓf
z І್ 狀ሯʕʘϓʱdШ 不̙˸ʱ
離Ͼ不ҷᜊՉଡ଼ϓഐ࿴ʘ΂О๓ኒfc 
z ሯ༟ 料ሯf
z ሯf
z ආ 行א
˖΁fc 
z ආ 行೮াЪุʘ೻όӻ୕f
z ̥຾ɛ 力ࠠ力˥e˸˥യ՟eओ 力ंʕʱ 離א
來͊຾ʷኪ̋ʈஈ 理f
z ў 兩၇˸ɪ不ৣ˙f
z Җ 狀f
z ୌΥɨ 列ሯj
­ε၇ 類ҏ 列ሯf
­޴連ࠠ量ϵʱʘʞɤdϾ˲ʱɿ 量ࠠ量ϵʱʘʞɤf
­ʱɿ量ࢨ異Չఊ᜗ఊʩ 數ࢨ異Ͼிϓf
z אܼ不ࠠ量ਿᓾ 來
f
z ίɓ 連串ࡡ料ሯf
z f
z ሯʕʘϓʱd̙ঐ 來ࡡ料ʿ 不א不Սจ̋ɝʘdɰ 不ึ
א不ϓʱў 量不ࠠ量א不ϓʱᐼ 量不ࠠ量ϵʱʘɚɤf
z ሯf
z ي流І͟൱ 易ሯf
z Ӻഃ͜௄f
z ሯᏐ͜ 領೯f
z Эᗫ切ԨୌΥɨ 列j
­ٙي數̻ͦѩʱɿ 量dՉʱɿ 量ў 量ϵʱʘɤdʱɿ 量ྺ
ў 量ي不ה列ʘ৷ᗫ切ঐਿf
­ٙي數̻ͦѩʱɿ 量dՉʱɿ 量ў 量ϵʱʘɚd˲ʱɿ 量ў
量ϵʱʘʞf
­f
­不඲ 不๓ኒf
z ʱ 類ሯୋɓeୋɚॴi͛
ʱ 類f   
 
- 2 - 
Regulation of New Chemical Substances Registration (Draft) 
ሯ೮া၍ 理ࣩ  
2. Exemption 
ᒀе  z ي理ʿʷኪஈ 理ሯf
z Мᎇ༊車ሯf
z Ⴁ೻ʕ͍ආ 行ʷኪˀᏐ 不̙ʱ離f
z Ͻ量ሯf
z ᕏሯf
z ሯf
z f
z ʊ列f
z ሯ 若ሯৰ̮f
z ሯ 若ሯ˲ί͍੬Դ͜ 狀ሯৰ̮f
z ֛ܸ不ሯ 類йf  
3. Registration Approval and Safety Assessment Report 
Types of Registration
೮া類ۨInformation 
requirement
Ӌ  Valid 
Period 
ࠢ  
Standard Registration
ᅺ๟೮া   Appendix 1
ڝ錄1 5 years 
5年 
Simplified Registration
ᔊ易೮া   Appendix 2
ڝ錄2 1 year 
1年  
೮া
d不f  
 
ɧ၇೮া 類f  
 
ᔊ易೮াeˇ 量೯ഗอ೮া˖
ˇ 量މࠢ1年ˇ 量೮াʘЭᗫ 切ʞ 年f 
 Small Quantity 
Registration  
ˇ量೮া  Appendix 3
ڝ錄3 1 year 
1年 Types of 
registration 
೮া類  
 
̬ʘ 年፩ɝ 量፯኿೮া 類f  Appendix 4 
ڝ錄4 
Registration for 
chemicals with 
special forms or 
purposes 
 ͜௄
ሯ೮া  ሯୌΥɨ 列ʞʘ 年፩ɝ 量፯኿೮া 類j  
೯͜௄f  
೯͜௄f  
f  
Эᗫ 切f  
೮াɛ͡ሗЭᗫ 切ᆽႩ˖΁f  Appendix 5 
ڝ錄5 
Joint registration
聯Υ೮া  兩ආ 行聯೮াd 聯ሯᐼ 量඲累̋f  
ሯΌ਷ 年ᐼ 量֛量೮া 類ᜊ更ආ行聯೮াf   
 
- 3 - 
Regulation of New Chemical Substances Registration (Draft) 
ሯ೮া၍ 理ࣩ  
CMR substances 
CMRሯ  ୌΥᔊ易೮াၾˇ 量ආ 行ᅺ๟೮াf  
4. Registration 
approval 
document 
೮া˖΁  ೮া˖΁Ꮠা༱ɨ 列ԫධj  
ɓe೮াɛਿ͉༟ 料f 
ሯᇜᇁf  
೮া͜௄f  
೮া 類f  
ಂගf  
5. Information 
dissemination 
༟ৃʮක  ᛆ 利j  
ሯᇜᇁf  
ʱ 類ʿᅺͪf  
ي理༟ৃf  
ݭ理༟ৃf  
ʞeτΌԴ͜༟ৃf  
六౧ 露f  
6. Inclusion in 
the inventory 
of chemical 
substances
列ي
ሯ૶ఊ  ʕ̯˴၍ዚᗫ੻ਗ਼ɨ 列ಂʮѓ 列ሯ૶ఊj  
ɓeҁϓᅺ๟೮াတʞ 年f  
ɚeҁϓˇ 量೮াတʞ 年˲ୌΥЭᗫ 切f  
൙Пၾ 暴露ۃ列f  
̬eҁϓˇ 量೮া˲ୌΥЭᗫ 切ۃ列f  
ආ 行聯ϣҁϓ೮াတʞ 年f  
六Ꮠ 列f  
7. Confidentiality 
of chemical 
names 
ڭ
留  ሯʮѓ 列ڭ留ሯΤ၈dᏐୌΥɨ 列׵列ۃ六ᚐj  
೮াɛʘਠุዚ੗f  
ɚe೮াɛତʊમ՟ 行f  
˸Υ 理၍༸՟੻f  
ʞ 年ۃ六ɓϣf  
8. Others 
Չ˼  e໾΁e͡ᔧe༟ৃ 留f  
9. Effective date Іʕശ͏਷ɓϵ 零̬年݄行f  
 
- 4 - 
Regulation of New Chemical Substances Registration (Draft) 
ሯ೮া၍ 理ࣩ  
ɓ  
ᅺ๟೮া -࢙  
1. ሯਿ͉፫ 識༟ৃ 
ሯ፫ 識༟ৃ 
2. ሯႡிe͜௄ձ 暴露༟ৃ 
Ⴁிʿ፩ɝ༟ৃe͜௄༟ৃe 暴露༟ৃ 
3. ʱ類ၾᅺͪ  
ي理࢙  
4. τΌԴ͜༟ৃ  
ރ漏ஈ理eஈໄၾᎷπe༶፩༟ৃe 暴露છՓ/ɛԣ
ᚐ 
5. ي理༟ৃ  
ሯ狀࿒eအᓃ /ᓃe੗ 度ڷ數j͍Ԕቐ /˥e˥ʕ๓༆ 度eႋंᏀe
৪˦ᓃe 易e pHeІዷ๝ 度eᓂ度e金׌  
6. ݭ理༟ৃ 
eіɝeͤᇮeͤᇮ 刺׌/e଻ຒ 刺ݭ
ਗ 力ልኒ 量eіɝeͤᇮe͛ಟ /׌  
7. ൙П  
൙П  
8. 暴露൙П 
暴露e 暴露量ࠑ  
௪ൗ:  
፬ 理f 
ɚe年፩ɝ༺ɓʮኚў˸ɪ 不တɤʮኚ˲ 不ʿ
ሯ CMR൙Пၾ 暴露൙Пf  
ɧe年፩ɝ༺ɤʮኚў˸ɪ 不˲ 不ிϓɛ᜗਄ੰ
d੻еৰ౤̈ 暴露൙Пf  
d
൙Пၾ 暴露൙Пf  
ي理ݭ理ሯ೮
াॴй౤Զ࿁Ꮠʘ಻༊ 數fˇί༈ॴй̀ 
 
- 5 - 
Regulation of New Chemical Substances Registration (Draft) 
ሯ೮া၍ 理ࣩ  
༟ৃf  
 
ڌ  
ي理༟ৃ ୋɓॴ ୋɚॴ ୋɧॴ ୋ̬ॴ
ሯ狀࿒ Ǹ Ǹ Ǹ Ǹ
အᓃኑոᓃ Ǹ Ǹ Ǹ Ǹ
ᓃ Ǹ Ǹ Ǹ Ǹ
੗度 Ǹ Ǹ Ǹ Ǹ 
ڷ數j͍Ԕቐ˥ Ǹ Ǹ Ǹ Ǹ
˥ʕ๓༆ 度 Ǹ Ǹ Ǹ Ǹ 
ႋंᏀ Ǹ Ǹ Ǹ Ǹ
৪˦ᓃ Ǹ Ǹ Ǹ Ǹ
易Ǹ Ǹ Ǹ Ǹ
Ǹ Ǹ Ǹ Ǹ
Ǹ Ǹ Ǹ Ǹ
Ǹ Ǹ Ǹ Ǹ
Іዷ๝度 Ǹ Ǹ Ǹ Ǹ 
ᓂ度  Ǹ  Ǹ 
金Ǹ Ǹ
ݭ理༟ৃ ୋɓॴ ୋɚॴ ୋɧॴ ୋ̬ॴ
eіɝeͤᇮ Ǹ Ǹ Ǹ Ǹ
ͤᇮ刺Ǹ Ǹ Ǹ Ǹ
଻ຒ刺Ǹ Ǹ Ǹ Ǹ
Ǹ Ǹ Ǹ Ǹ
Ǹ Ǹ Ǹ Ǹ
ਗ 力ኪ   Ǹ Ǹ Ǹ 
ልኒ量eіɝeͤᇮ  Ǹ Ǹ Ǹ
Ǹ Ǹ Ǹ
Ǹ
ڌ說j 
a. 年፩ɝ༺ɓʮኚў˸ɪ 不eɤʮኚў˸ɪ 不တɓϵʮኚ
eɓϵʮኚў˸ɪ 不ሯ
ي理ݭ理jୋɓॴeୋɚॴeୋɧ
ॴeୋ̬ॴ಻༊༟ 料f 
b. ೯͜௄
˲年ي理ݭ
理Ӌ jୋɓॴ಻༊༟ 料f 
c. ሯ˲ 年፩ɝ 不တɓʮ
dɓʮኚў˸ɪ 不eɤʮኚў˸ɪ 不eɓϵ
ي理ݭ理ࠅ
jୋɓॴeୋɚॴeୋɧॴeୋ̬ॴ಻༊༟ 料f 
d. ي理ݭ理༟ৃʘୋɓॴeୋɚॴeୋɧॴeୋ̬ॴ
ʘ΢ධͦ಻༊༟ 料ආ 行f  
 
- 6 - 
Regulation of New Chemical Substances Registration (Draft) 
ሯ೮া၍ 理ࣩ  
ɚ  
ᔊ易೮া-࢙  
1. ሯਿ͉፫ 識༟ৃ 
ሯ፫ 識༟ৃ 
2. ሯႡிe͜௄ձ 暴露༟ৃ 
Ⴁிʿ፩ɝ༟ৃe͜௄༟ৃe 暴露༟ৃ 
3. ʱ類ၾᅺͪ  
ي理࢙  
4. τΌԴ͜༟ৃ  
ރ漏ஈ理eஈໄၾᎷπe༶፩༟ৃe 暴露છՓ/ɛԣ
ᚐ 
5. ي理༟ৃ  
ሯ狀࿒eအᓃ /ᓃe੗ 度ڷ數j͍Ԕቐ /˥e˥ʕ๓༆ 度 
௪ൗ:  
፬ 理f  
 
- 7 - 
Regulation of New Chemical Substances Registration (Draft) 
ሯ೮া၍ 理ࣩ  
ɧ  
ˇ量೮া-࢙  
1. ሯਿ͉፫ 識༟ৃ 
ሯ፫ 識༟ৃ 
2. ሯႡிe͜௄ձ 暴露༟ৃ 
Ⴁிʿ፩ɝ༟ৃe͜௄༟ৃ  
௪ൗ:  
፬ 理f  
 
- 8 - 
Regulation of New Chemical Substances Registration (Draft) 
ሯ೮া၍ 理ࣩ  
̬  
年፩ɝ 量ၾ೮া類֛( ɓ) 
年א數ɝ量 ೮া類ۨ 
͊༺ɓϵʮ˘  ˇ量೮া 
ɓϵʮ˘˸ɪ͊༺ɓʮ
ኚ ᔊ易೮া 
ɓʮኚ˸ɪ  ᅺ๟೮া  
  
 
- 9 - 
Regulation of New Chemical Substances Registration (Draft) 
ሯ೮া၍ 理ࣩ  
ʞ  
年፩ɝ 量ၾ೮া類֛( ɚ) 
 
年 
Ⴁி 
፩ɝ量 ೯  ၾႡ
೯  ᅀѧ
ي  ي  Эᗫ切ၳ
ي 
(ۃ
ᆽႩ) 
͊༺ɓʮ
ኚ е೮া ˇ 量೮া ˇ 量೮া ˇ 量೮া е೮া
ɓʮኚ˸
ɪ͊༺ɤʮኚ ᔊ易೮া ᔊ 易೮া ᔊ 易೮া ᔊ 易೮া
ɤʮኚ˸
ɪ ᅺ๟೮া ᅺ๟೮া ᅺ๟೮া ᅺ๟೮াˇ量೮া