| Legislative： |
1.Adopted and promulgated by the Bureau of Standards, Metrology and Inspection, Ministry of Economic Affairs on 21 October, 2008 and came into force on 1 January 2009
2.Amended by the Bureau of Standards, Metrology and Inspection, Ministry of Economic Affairs, on 24 May, 2010 and came into force on 1 July 2010.
3.Amended by the Bureau of Standards, Metrology and Inspection, Ministry of Economic Affairs, on 4 February 2020 and came into force on 1 March 2020.
4.Amended by the Bureau of Standards, Metrology and Inspection, Ministry of Economic Affairs, on 28 September 2023 and came into force on 1 October 2023. |
| Content： |
1. These Directions are stipulated for the inspection of toys.
2. The inspection authority mentioned in these Directions shall mean the Bureau of Standards,
Metrology and Inspection (the BSMI) of the Ministry of Economic Affairs and its branches.
3. Toys evaluated in accordance with Regulations Governing of the Criteria for Identification of
Risks of Hazard are divided into toys with low risk of hazard and medium risk of hazard (shown in
Appendix 1). The following inspection schemes are adopted in accordance with the risk of hazard:
(1)Toys with low risk of hazard: Declaration of Conformity.
(2)Toys with medium risk of hazard: Monitoring Inspection or the Registration of Product
Certification [type test (Module 2) + declaration of conformity to type (Module 3)].
For products containing both toys with low risk of hazard and medium risk of hazard, the inspection
schemes for toys with medium risk of hazard shall apply.
4. Inspection items, sample selection and test methods are stipulated in Appendix 2.
5. The inspection method of monitoring inspection:
(1) Inspection location: the inspection authority or inspection bodies commissioned by the BSMI.
(2) Inspection time limit: 7 workdays from the day when the sample of commodities subject to
inspection arrives at the inspection bodies.
(3) Requirements for the commodity inspection mark are as follows:
a. The Obligatory Inspection Applicant may apply to the inspection authority to purchase the
product inspection mark with character "C" printed by the BSMI or apply for product inspection
mark with character "M" and the designated code for the purpose of self-printing.
b. When the Obligatory Inspection Applicant applies for inspection, if the batch number is filled in
on the inspection application and the batch number is also marked on the body or minimum
packaging of the product, the Obligatory Inspection Applicant may self-print the product inspection
mark. The identification number consists of the character "M" and a designated code (including a
seven-digit batch number), arranged in close proximity to the right or below the basic diagram,
marked in top and bottom rows. This is for post-market management mechanisms and product
traceability. Obligatory Inspection Applicant
For example: 2007001 [as the first batch of toys produced in July 2020; the first and second
numbers are the rear 2 numbers of the western year of the produced date; the third and fourth
numbers are the month of the produced date; the fifth to seventh numbers are serial numbers]
An example:
or M00000
M00000 Batch No. 2007001
Batch No. 2007001
(4) Inspection method:
a. When the Obligatory Inspection Applicants apply for inspection according to the Regulations
Governing Monitoring Inspection, they should attach photos of the physical Chinese labelling or
related information such as pre-produced Chinese marking samples or patterns for the sampled
batch of toys or at least one toy when the batch is not sampled. All product names should be
registered in the name column of the inspection application form in the automated system of the
BSMI, accompanied by relevant electronic files. Paper applications may be processed with attached
forms. Failure to comply with the aforementioned requirements will result in refusal of acceptance.
The Obligatory Inspection Applicant is requested to reapply after making the necessary corrections.
b. For toys applied for inspection by the same Obligatory Inspection Applicant, if ten consecutive
batches are examined under the batch-by-batch examination and meet the requirements, the
inspection method will be changed to random-selected batch inspection with a probability of 50%
for each batch. After another ten consecutive batches pass inspection, the inspection method will be
further adjusted to random-selected batch inspection with a probability of 20% for each batch.
c. If a randomly selected batch is found to be non-compliant, the inspection method for subsequent
goods applied for inspection by the same Obligatory Inspection Applicant will be changed to
batch-by-batch examination for ten consecutive batches of inspections. When all of the ten batches
of goods for inspection meet the requirements, Item b. of Subparagraph (4) of Paragraph 5 will
apply to the subsequent batches.
d. The sampling rate of the randomly selected batch is as follows: for batch with less than 100 items,
one item shall be randomly sampled for every five items, with a minimum of one item and a
maximum of five items; for batch exceeding 100 items, one additional item should be randomly
sampled for every additional twenty items. Two samples (sets) should be taken for each item.
However, the sampling rate and quantity may be adjusted as needed based on actual circumstances.
e. For batch-by-batch examination and random-selected batch inspection, only key inspection items
within the selected batch are inspected. Other inspection items outside the key inspection scope will
be inspected by the BSMI’s surveillance plan.
f. When there is a type test report which demonstrates that all items listed in the inspection
application of the selected batch under batch-by-batch examination and random-selected batch
inspection are compliant, sampling and inspection can be exempted. Only items like packaging,
exterior appearance and labelling shall be on-site verified. The type test report shall be issued by the
BSMI-designated testing laboratory for toys (hereinafter referred to as the “designated testing
laboratory”) and such report shall be for the same type of toys inspected and issued within 12
months prior to the application for inspection. However, if there are safety concerns, samples can be
taken for inspection.
g. For the batches not selected under the random-selected batch inspection, it is necessary to check
the computer database to confirm whether the inspected goods is applicable to the inspect method
“release after document examination.” A verification checklist will be generated by the automated
system and the verification shall be conducted in the following manner:
(a) Labelling is verified at the possibility of 50%. Items of verification include exterior appearance,
commodity inspection mark and Chinese label. Sampling for inspection may be exercised if
necessary.
(b) For batches not verified, the procedure “release after document examination” shall apply. Items
for document examination are specified in item a. of subparagraph (4) of Paragraph 5.
h. For cases where the inspection result is non-compliant, and a re-inspection is required, the
following procedures shall be followed in addition to the Regulations Governing Disposition of
Commodities Failing Inspection:
(a) If the improvement plan for non-compliant products is to replace spare parts (accessories), a
valid certificate proving that the replacement spare parts (accessories) meet the requirements shall
be provided.
(b) For cases of re-inspection of non-compliant products, the sampling rate and inspection items
shall be handled according to subparagraph item d. and item e. of subparagraph (4) of Paragraph 5.
However, items that have failed to pass the inspection and are re-submitted for inspection after
improvement shall be sampled and the sampling rate shall double.
(c) For cases of re-inspection, when the non-compliant parts of the products are approved by the
BSMI to be destroyed, the item can be exempted from sampling.
i. If the inspection result of sampling or monitoring program shows that a toy is found
non-compliant with the inspection standards or the required conformity assessment procedures for
the tory are not completed, the inspection method for subsequent goods applied for inspection by
the same Obligatory Inspection Applicant will be changed to batch-by-batch examination for ten
consecutive batches of inspections. When all of the ten batches of goods for inspection meet the
requirements, item b. of subparagraph (4) of Paragraph 5 will apply to the subsequent batches.
6. The inspection method of the Registration of Product Certification:
(1) Application procedures for type test reports, test principles, determination principles for type and
series type:
a. Application procedures for type test report: The Obligatory Inspection Applicant shall fill in the
Commodity Type Classification Form for Registration of Product Certification (Appendix 3) and
submit samples to apply for type testing at the designated testing laboratory.
b. Test principle:
(a) Sample quantity: At least 3 samples of each product of the main type and series type shall be
submitted.
(b) Type test items: key inspection items.
(c) Fee for type test: In accordance with the fee regulations of the designated testing laboratory.
c. Determination principles for Type and series type:
(a) If the main processes of toys are the same, and the primary materials, raw materials, or
components are identical, and the basic design is also the same, the toys are considered as the same
type. The most complex one can be determined as the main type, and the others are considered as
series types.
(b) If the main processes of toys are the same and the same group of materials is used, and the toys
have a similar appearance, they are considered as the same type and there is no series type. If there
are differences in appearance, the toys are considered as series types.
(2) When applying for the Registration of Product Certification, the applicant is required to submit
basic documents and conformity assessment documents in accordance with Application Procedures
for Registration of Product Certification. Additionally, the applicant should provide the following
technical documents when submitting the application to the inspection authority:
a. Commodity Type Classification Form for Registration of Product Certification (Appendix 3)
signed by a designated testing laboratory.
b. Declaration of Conformity to Type (Appendix 4).
c. Declaration for the Validation of Toys (Appendix 5):
(3) Review Timeframe: 14 workdays (excluding the time of waiting for the supplementary data). An
additional 7 workdays will be required for cases involving sample testing.
(4) Validity period of the certificate of the registration of product certification: 3 years. The
certificate holder may apply for extension for another 3 year for once only.
(5) Commodity inspection mark: character “R” and designated codes (assigned by the BSMI
when issuing the certificate). The commodity inspection mark shall be printed by the
Obligatory Inspection Applicant and be affixed on the body of the commodity or minimum
packaging of the product. The character “R” and the designated codes shall be placed in
close proximity to the right or below the basic diagram.
An example:
or R00000
R00000
(6) Any change to the commodities registered on the certificate of the registration of product
certification shall be handled in accordance with the following:
a. For addition of series type (without changing the original main type), the Commodity Type
Classification Form for Registration of Product Certification and type test report signed by a
designated testing laboratory shall be submitted to the inspection authority for the application of the
re-issuance of the certificate.
b. For changing the main type or series type, the Commodity Type Classification Form for
Registration of Product Certification and type test report signed by a designated testing laboratory
shall be submitted to the inspection authority for approval.
7. The inspection method of Declaration of Conformity:
(1)The low risk of hazard toys listed in Appendix 1 are classified by the material of commodities as
below:
a. Paper.
b. Plastic.
c. Other composite materials: Commodities contain more than 2 materials.
(2) The procedures to apply for type test report and test principles:
a. The procedures to apply for type test report: the Obligatory Inspection Applicant shall fill in the
Commodity Type Classification Form for Declaration of Conformity (Appendix 6) and apply for
type test report at the designated testing laboratory.
b. Test principles:
(a) Selection of test items: The designated testing laboratory selects the most complex or high-risk
items for each type of commodities from the List of Declaration of Conformity Type Classification.
If the total number of items in the List of Declaration of Conformity Type Classification is less than
or equal to 100, one test item is selected from every 20 items for testing; If the total number of items
is more than one hundred, one test item is selected from every 50 items for testing.
(b) The testing items for the type test: key inspection items
(c) Numbers of samples: The Obligatory Inspection Applicant shall submit at least 3 samples for
each item.
(d) Fee for type test: in accordance with the fee regulations of the designated testing laboratory.
(3) The Obligatory Inspection Applicant shall keep the following documents in accordance with
Article 46 of the Commodity Inspection Act:
a. Declaration of conformity.
b. Technical documents:
(a) Type test report issued by designated testing laboratory.
(b) Commodity Type Classification Form for Declaration of Conformity signed by designated
testing laboratory.
(c) Declaration for the Validation of Toys.
(4) For a product that its applicant has signed a declaration of conformity and retained relevant
technical documents, if there are any of the following conditions in Appendix 6 and the type test
report, the applicant shall submit the original Commodity Type Classification Form for Declaration
of Conformity, the updated Appendix 6, the original type test report, or samples, etc., to the
designated testing laboratory and apply for changes. The testing principles for such changes are as
follows:
a. If the total number of items in the List of Declaration of Conformity Type Classification is over or
equal to that specified in Sub-item (a) of Item b. of Subparagraph (2) of Paragraph 7, the testing
shall be conducted in accordance with Item b. of Subparagraph (2) of Paragraph 7.
b. If the total number of items in the List of Declaration of Conformity
Type Classification is less than that specified in a. of Sub-item (a) of Item b. of Subparagraph (2) of
Paragraph 7, only Appendix 6 shall be updated.
(5) Commodity Inspection Mark: character “D” and designated codes. The Obligatory Inspection
Applicant shall apply to the inspection authority for the designated code of Declaration of
Conformity. The Obligatory Inspection Applicant shall self-print the Commodity Inspection Mark in
accordance with regulations, place it to the right or below the basic diagram, and affix it to the
product body or the smallest external packaging.
or D00000
D00000 |