TAIWAN Existing Chemical Nomination & New Chemical Notification

Mar. 17th, 2011
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1. Existing Chemical Nomination (ECN)

  

Existing Chemical Substances (ECS) are defined as those that have been manufactured or imported within 15 years prior to the effective date of the regulation and are handled by labor workers.

 

The following chemical substances are excluded from the subject of this regulation:

 

(a) substances and polymers that occur in nature, without physicochemical treatment;

(b) polymers that the 2% rule is applicable;

(c) chemical substances contained in experimental machines and equipments;

(d) Non-isolatable intermediates in reactors or reaction process;

(e) mixtures (but the new substances in the mixture are not excluded);

(f) articles;

(g) chemical substances under the supervision of Customs (stored in bonded warehouse or otherwise not yet cleared through the Customs of ROC);

(h) chemical substances for military uses;

(i) incidental reaction products (by-products) or impurities with no commercial value;

(j) wastes.

 

Notifier: Any local or overseas legal entities are entitled to submit nomination for ECS Substance completed nomination by the end of 2010 will be included in the Inventory of Existing Chemical Substance (hereinafter referred to as IECS) and therefore exempted from New Chemical Substance Notification

 

2. New Chemical Substance Notification (NCN)

 

New Chemical Substances (NCS) are defined as those that are not listed on the Taiwan Inventory of Existing Chemical Substance. Manufacturer or importer of a new chemical substance should file a prior notification with CLA together with a risk assessment report to obtain specific permission unless the substance is categorically excluded from the obligation of notification. The categorical exclusions are not different from those for existing chemical substances.

 

Notifier:Different from existing substance nomination, according to the draft regulation, only legal entities located in Taiwan can file not

ifications for new chemical substances.

 

There are three types of notification/notice: Notice, Simplified Notification and Completed Notification.

 

New substance notification type

Conditions

Timeframe

Notice

For new substances manufactured or imported in quantity between 0.01 – 0.1 ton/year

10 calendar days

Simplified Notification

For new substances manufactured or imported in quantity between 0.1 – 1 ton/year

30 calendar days

Polymers entitled to Simplified Notification

Completed
Notification

Substances having been listed on at least two country Inventories

30 calendar days

Substances not satisfying the conditions above

 

 

3. Timetable of the Existing Chemical Nomination (ECN) and New Chemical Substance Notification (NCN)

  

 

 

Our Services

 

  • Existing Chemical Substance Nomination
  • New Chemical Notification
  • Comply with Taiwan GHS
  • Regulatory Consultancy