Taiwan Releases 4 Cosmetic Regulation Drafts

Takehome:

On Jul 19, Jul 23, Jul 24 and Jul 27, 2018, TFDA released 4 cosmetic regulation drafts, “Administrative Measures for Registration Exemption Application of Imported Special-use Cosmetics”, “Administrative Measures for Cosmetics Supply Source and Flow Information”, “Administrative Measures for Cosmetics Recall” and “Administrative Measures for Cosmetics Border Inspection". The implementation date of the four drafts has not yet been determined.

The main contents of “Administrative Measures for Registration Exemption Application of Imported Special-use Cosmetics” include:

Legal basis
Applicant qualifications for imported special-use cosmetics registration exemption

Cosmetics used as examination samples for registration;
Cosmetics used for research and experiment;

Dossiers necessary for registration exemption application of imported special-use cosmetics used as examination samples

Application form;
Copy of certificate of incorporation or business license;
Power of attorney from overseas manufacturers in the last two years;
Outer packaging, containers and instructions, etc.;
Other dossiers designated by central competent authority;

Dossiers necessary for registration exemption application of imported special-use cosmetics used for research and experiment

Application form;
Copy of certificate of incorporation or business license;
Research plan, including research aim, method, usage, dosage, time and total demand;
Outer packaging, containers and instructions, etc.;
Other dossiers designated by central competent authority;

Maximum number of registration exemptions for imported special-use cosmetics

Cosmetics used as examination samples, no more than 12 bottles/boxes/pots/packs/bags per item;
Cosmetics used for research and experiment, no more than the estimated total demand

Inadmissible conditions for registration exemption

Inconsistencies between dossiers and application contents;
Cosmetics contain banned ingredients or restricted ingredients exceeding the limitation;
Fake dossiers;
The applicant has applied for the same product within six months and was approved by TFDA ( Not applicable for cosmetics used for research);
Other conditions do not comply with regulations or TFDA announcements;

Applicant shall record the actual import number and usage of these special-use cosmetics and keep the record for at least 3 years
Withdrawal and abolition conditions of registration exemption

Fake dossiers;
Use cosmetics as supply, sales, gifts, public displays or trials for consumers;
Applicant didn’t record cosmetic information as required;
Cosmetics has the risk of harm to human health;

The main contents of “Administrative Measures for Cosmetics Supply Source and Flow Information” include:

Legal basis
Cosmetics supply source and flow information that manufacturers and importers should establish

Manufacture or import information

a) Product name, notification number or license number, cosmetic category, usage, packing specifications and net content;

b) Batch number;

c) Product total number;

d) Manufacturing date, expiry date or shelf life;

e) Import date and customs declaration number;

Flow information

a) Supplier’s name, address, contact person and phone number;

b) Product name, notification number or license number, cosmetic category, usage, packing specification and net content;

c)Batch number;

d) Product total number;

e) Manufacturing date, expiry date or shelf life;

f) Delivery date

Cosmetics supply source and flow information that distributors should establish

Supply source information

a) Supplier’s name, address, contact person, and phone number;

b) Product name, notification number or license number, cosmetic category, usage, packing specification and net content;

c) Batch number;

d) Product total number;

e) Manufacturing date, expiry date or shelf life;

f) Receipt date;

Flow information

a) Supplier’s name, address, contact person and phone number;

b) Product name, notification number or license number, cosmetic category, usage, packing specification and net content;

c) Batch number;

d) Product total number;

e) Manufacturing date, expiry date or shelf life;

f) Delivery date

Cosmetic enterprises shall keep product supply source and flow information for at least 5 years.

The main contents of “Administrative Measures for Cosmetics Recall” include:

Legal basis
Cosmetics recall level

First level

a) Contain banned ingredients;

b) Contain restricted ingredients or there are minimal residue of banned ingredients;

c) Manufactured by factory that has not been registered

d) Cosmetics’ notification or license that have been revoked or abolished;

e) Cosmetics from unknown sources

Second level

a) Cosmetics didn’t complete product notification or establish PIF, and didn’t improve within time limit

b) Special-use cosmetics that didn’t register in TFDA or change registration items without authorization, and didn’t improve within time limit;

c) Supply, sell, display, provide for consumer trials with personal use special-use cosmetics or special-use cosmetics that are exempted from registration, and didn’t improve within time limit;

d) Outer packaging or containers that are not marked as required;

e) Distributors change product labels, packaging, container or instruction and sell it;

f) Cosmetics that violate “Standards for Cosmetics Manufactories” or Cosmetic GMP;

g) Cosmetics with fake, exaggerated or medical marks

Time limit for first and second level cosmetic recall
When municipal or county competent authorities recall cosmetics, they shall notify TFDA and other counties or cities, as well as disclose recalled cosmetics information to the public

Product name;
Product notification or license number;
Product batch number or sequence number;
Manufacturer or importer’s name, address and phone number;
Recall reasons

Manufacturers or importers shall establish cosmetics recall procedures
Manufacturers or importers shall notify distributors to recall products within 7 days of receiving notification from the competent authority. For first level recalled cosmetics, shall notify distributors within 3 days
Manufacturers or importers shall submit a recall plan to the competent authority within 14 days of receiving notification. For first level recalled cosmetics, within 7 days

Manufacturer or importer’s name, address and phone number；
Product name;
Product notification or license number;
Product batch number or sequence number;
Total amount of manufactured or imported products, sales quantities, stocks, categories and quantities of products that have been recalled and have not;
Distributors’ name, address and sales quantities;
Recall reason and potential harm;
Estimated date of recall completion;
Method and content to inform the distributor and other measures taken

Temporary storage method of recalled products
Manufacturers or importers shall submit a product recall report to the competent authority after completing recall

Manufacturer or importer’s name, address and phone number
Product name;
Product notification or license number;
Product batch number or sequence number;
Total amount of manufactured or imported products, sales quantities and stocks;
List of category and quantity of products recalled by each enterprise;
Recall completion date, recalled products storage place, subsequent disposal methods and date;
Products that have been destroyed, attaching photos or videos of destroy process;
Follow-up preventive measures;

After receiving product recall report, the competent authority should conduct on-site inspections

The main contents of “Administrative Measures for Cosmetics Border Inspection” include:

Legal basis
Definition of terminology
Time of border inspection application, method of entrustment and required dossiers
Dossiers necessary for cosmetic border inspection application

Border inspection application form;
Copy of import customs declaration;
Other dossiers announced by inspection authority;

Inspection method

Batch-by-batch inspection;
Sampling inspection (sampling inspection rate is 2% to 50%)
On-site inspection

Inspection authority's sampling quantity limit and method, place and inspection order
Imported cosmetics release requirements and restrictions

Have sampling difficulties
Inspection period exceeds 5 days
Corruptible products

After passing the border inspection, the inspection authority shall issue a written import approval notice. For those who fail to pass the border inspection, an import failure notice shall be issued. The applicant can reapply within 15 days after receiving notice.
Rejected products disposal method, including return, destroy or recall
Border inspection fee