| Legislative： |
1.Adopted and promulgated by Ministerial Order No. 10920005830, BSMI, MOEA on 29 September, 2020. |
| Content： |
1. These Directions are hereby stipulated for implementation of inspection procedure to infant bath
tub products.
2. These Directions are applicable to products for supporting and/or surrounding the infant at the
reclining, sitting, or standing positions when being bathed by babycarers; the bath tubs, barriers, or
similar products which serve for the purpose of containing water and could be placed at the tops of
the adult bath tubs, within the sink, or surfaces of other objects.
3. The inspection methods for infant bath tub products are type approved by batch inspection and
Registration of Product Certification (RPC) Scheme [type test (Mode2) + declaration of conformity
to type (Mode3)].
4. Inspection Standards, Inspected Items and Inspected Labeled Items:
(1)Inspection Standards: CNS 16025:2017 - Child Use and Care Articles – Infant Bath Tubs.
(2)Inspected Items:
a.Physical performance test: Items including “dangerous tips or sharp edges”, “openings”, “labeling
(permanent)”, “Static load” and any type containing items as “small objects”, “Anti-collapse”,
“Shear point, squeeze point and pinch”, “protective components”, “Restraint system”, “Specific
requirements for suction cup” and “toys” shall all be inspected in accordance with the relevant
requirements in CNS 16025.
b.Chemical quality test: If any type of products has the surface coating, it is required to submit the
relevant declaration of the conformity of quality requirement for the lead content in the coating to
comply with Section 5.3 of CNS 16025 to the Bureau of Standards, Metrology and Inspection of the
Ministry of Economic Affairs (hereinafter referred to as BSMI) and its its subsidiary Branches
(hereinafter referred to as the inspection authority) for reviewing when applying for product type
approval or product certification registration.
(3)Chinese Labeling: All labelled text shall be in traditional Chinese and include the matters and
contents labeled shall comply with CNS 16025 and relevant regulations of the Commodity Labeling
Act.
(4)Commodity Inspection Mark: The mark shall be printed by the inspection applicant in
accordance with the provisions of the “Regulations Governing the Use of Commodity Inspection
Mark” and affixed to the prominent place of the commodity.
5. Type Approval by batch inspection :
(1)Principle for Determination of Type:
a.Same type: the Infant bath tub products with the same main structure materials (i.e. plastic and
non-plastic materials).
b.Main type: the most complex structure in the Infant bath tub products in the same type. Choose
one the Infant bath tub products as the main type, if there are many same types with the same
complixity of structure.
c.Series type: other commodities except the main type, based on complixity of structure.
(2)Type test place of inspection: inspection authority or designated test laboratories recognized by
BSMI.
(3)Type test of inspection items: Main commodities to be inspected the items including “dangerous
tips or sharp edges”, “openings”, “labeling (permanent)”, “Static load” and any type containing
items as “small objects”, “Anti-collapse”, “Shear point, squeeze point and pinch”, “protective
components”, “Restraint system”, “Specific requirements for suction cup” and “toys” shall all be
inspected in accordance with the relevant requirements in CNS 16025. All series type commodities,
the test is only required for different parts of the products to main type.
(4)Applicant shall submit sample of commodity to be inspected and 3 copies of technical documents
as follows:
a.The type registration of infant bath tub product certification table.
b.Colored photo of infant bath tub product (include actual size; please include 4" x 6" electronic
photo for front, back and side).
c.Relevant declarations of the conformity of quality requirement for the lead content in the coating
complying with Section 5.3 of CNS 16025.
d.Chinese labels.
e.User's manual.
f.Commodity description, including product structure, product component list and item materials.
g.Samples: one of each type of infant bath tub commodity, inspection may be required more
samples if necessary.
(5)Type test fees: in accordance with fees charged by inspection authority or Designated test
laboratories recognized by BSMI.
6. Type approval by batch inspection:
(1)Products should apply type approval first before batch inspection, applicant obligators should
obtain product type approval, before products are shipped out of factory or imported, file inspection
applications to the Bureau of Standards, Metrology and Inspection (BSMI) or its subsidiary
branches (hereinafter referred to as the inspection authority), may purchase the Roman letter “T”
Mark labels printed by the BSMI . The application will be not be accepted by the inspection
authority if the preceding requirements are not followed.
Example:
T00000
T00000 or
T means the prefix
00000 means the designated code
(Prefixes and designated codes shall be filled in depending on manufacturers)
(2)When applicant obligators apply for type approval certificate, applicant obligators should prepare
copied documents from the authority about company registration, business registration, factory
registration documents or other equivalent establishment registration documents to the inspection
authority.
(3)Certificate of product type approval review period: fourteen working days (excluding the time
waiting for supporting document; an additional 14 working days after receipt of the samples in case
sampling tests is required) since the inspection authority has accepted the application.
(4)Same batch inspection application of infant bath tub products should be the same applicant
obligator in same type.
(5)The inspection authority shall confirm that infant bath tub products have been registered in
type approval, one inspection application for children’s bedguards commodities, they are entitled to
the procedure of random-selected batch inspection at a sampling rate of 20%., those not sampled
will be in paper reviewed. For each application, 1 item will be randomly sampled out of every 3
items, with a minimum of 1 item and maximum of 5 items to be sampled. For each sampled item, 1
product will be randomly selected for inspection against the requirements mentioned in Article 5
and examined for their Chinese labeling as well as the Commodity Inspection Mark. The total
number of items and samples selected for inspection may be increased, if necessary.
(6)The inspection entity shall inspect the selected samples with one to two of the following test
items based on risk evaluations: “Shear point, squeeze points and entrapments”, “openings”,
“protective components” and “static load”. Items are inspected.
(7)Inspection period: five working days after the samples are delivered to the designated laboratory
or inspection authority.
(8)The inspection authority shall issue a notice of unsatisfactory inspection results for commodities
that do not comply with requirements. The obligatory inspection applicant may apply for
re-inspection without any charge for one time within 15 days after receiving such notice. Items of
products that do not comply with the requirements may be returned, destroyed, rectified under
surveillance or processed as required. Re-inspection is only limited to one time only. For items that
comply with the requirements may be released separately. Products that do not comply with the
requirements shall be processed in accordance with Regulations Governing Disposition of
Commodities Failing Inspection and Operation Procedures for Returning and Destroying
Commodity, to be specified as followings:
a.For commodities that do not comply with inspection requirements and are to be returned, the
obligatory inspection applicant shall report to the inspection authority and provide export-related
documents issued by the Customs, within three months after the commodities are returned in order
to close the case. The inspection authority will close the case after crosschecking the on-line export
information in the customs database.
b.For commodities that do not comply with inspection requirements and are to be destroyed, the
obligatory inspection applicant shall make application to the inspection authority by presenting the
notice of unsatisfactory inspection results, import declaration (not applicable for
domestically-manufactured products) and the destruction plan. The inspection authority shall
dispatch officers to monitor the execution of destruction plan.
c.For commodities that do not comply with inspection requirements and application for
re-inspection is to be made after taking rectification measures, the obligatory inspection applicant
shall apply to the BSMI by filling out the application form and presenting the notice of
unsatisfactory inspection results, import declaration (not applicable for domestically- manufactured
products), and verified improvement plan, together with products of items not sampled.
d.For re-inspection cases mentioned in the preceding paragraphs, the items will be sampled at a rate
double of that specified in Article 5. Products of items that are rectified under surveillance shall be
sampled and those complying with the requirements as a result of re-inspection can be released
separately. Products of items that still do not comply with the requirements shall be returned or
destroyed together with those not sampled. For products of non-complying items to be destroyed or
returned, if application for re-inspection is to be made for items not sampled, the obligatory
inspection applicant shall apply to the BSMI by filling out the application form and presenting the
notice of unsatisfactory inspection results as well as the import declaration (not applicable for
domestically-manufactured products). Upon approval by the BSMI, the obligatory inspection
applicant shall apply to the inspection authority for re-inspection by presenting the approval letter,
the notice of unsatisfactory inspection results and record of rectification/destruction under
surveillance.
(9)Where the products sampled are found not in compliance with the inspection requirements,
subsequent products with the same the obligatory inspection applicant shall inspected batch by
batch. The simplified sampling procedures mentioned in Article 5.3 shall be applicable after 3
consecutive batches and over triple amount of products in non-complying batch are inspected to be
in compliance with the requirements.
(10)For those items that have not been sampled, the inspection authority performing the inspection
shall adopt the approach of document review to compare the types of products submitted for
inspection based on the relevant information in the application.
(11)If there are changes in the scope of the registered products of the product type certificate (e.g.
changes to the main type or series of the type, inspection standards or inspected items, etc.), the
applicant shall apply for the type test report to the original report issuance unit and apply for
certificate renewal to the inspection authority.
7. Registration of Product Certification (RPC):
(1)Commodities that have been granted registration may be shipped out of the production premise,
or be exported or imported.
(2)Application for registration of product certification: After applicant has applied for type test in
Article 5, applicant submits hisa copy of the registration document of the company, business,
factory or other equivalent establishment registration documents of the applicant , the declaration of
conformity-to-type, the type-test report, relevant technical documents, a copy of quality
management system registration certificate and/or a copy of factory inspection report as required by
the appropriate modulesand other information or technical documents required by the BSMI in
Article 5.4.
(3)Registration of product certification review period: fourteen working days from application to
inspection authorities(excluding the time waiting for supporting document); an additional 14
working days after receipt of the samples in case sampling tests is required .
(4)Once obtained the RPC certificate, the applicant must print the Commodity Inspection Mark, the
Roman letter "R" and the designated code, which is the identification number of the RPC certificate.
Example:
R00000
R00000 or
R means the prefix
00000 means the designated code
(Prefixes and designated codes shall be filled in depending on manufacturers)
(5)Any amendment for the scope of product certification shall be reported to the inspection
authority for an amendment and for a certification replacement, applicant shall apply to original
type test place of inspection to change the type test report. |