| Legislative： |
1. Full text of 17 articles was promulgated by the Council of
Agriculture on May 8, 2019 per Order Nung-Liang-Tze
1081069113A, and was set to be effective on May 30, 2019. |
| Content： |
Article 1
These Regulations have been established in accordance with
paragraph 5 of Article 11 of the Organic Agriculture Promotion
Act (hereinafter referred to as the Act).
Article 2
Any institution or legal entity engaging in accreditation
activities shall have the following qualifications:
1. Have a system of conformity assessment of certification
bodies set up and implemented in accordance with ISO/
IEC 17011 and a Mutual Recognition Arrangement for the
accreditation scope of product certification bodies signed.
2. Be a member of International Accreditation Forum (IAF).
Article 3
Any institution or legal entity that engages in accreditation
activities shall submit the following documents to the Central
Competent Authority to apply for permission:
1. Copies of supporting documents regarding the establishment or
registration of the institution or legal entity.
2. Copies of the arrangement in subparagraph 1 of the previous
article.
3. Relevant documents for conducting accreditation activities.
4. Other documents required by the Central Competent Authority.
The documents in subparagraph 3 of the previous paragraph are as
the following:
1. Quality manual.
2. Scope of accreditation.
3. Areas and countries where the accreditation is to be
performed.
4. Accreditation standards: the standards for evaluating the
qualifications to provide certification services; the
required items are shown in the Appendix.
5. Assessment procedures: including initial assessment
procedures, surveillance procedures, renewal assessment
procedures, and extensional assessment procedures.
6. Assessment personnel: including internal regulations
regarding selecting, training, dispatching, and appraisal
of personnel, and requirements that eligible assessment
personnel shall receive the training held by the Central
Competent Authority or its designated body (institution) or
legal entities at least once every two years and obtain the
certificate of completion.
7. Rules for assessment operation.
8. Accreditation contract template.
9. Pricing standard.
Article 4
For institutions or legal entities that have passed the
permission review after applying according to the previous
article, the Central Competent Authority shall issue the
accreditation body permission, which shall include the following
items:
1. Name and address of the accreditation body.
2. Scope of accreditation.
3. Areas and countries where the accreditation may be performed.
4. Valid period.
The scope of accreditation stipulated in subparagraph 2 of the
previous paragraph is as the following:
1. Organic crops.
2. Organic livestock products.
3. Organic aquatic products.
4. Non-edible organic forest products.
5. Organic processing, packaging, and distribution.
The validity in subparagraph 4 of paragraph 1 is five years;
one year prior to expiration, the accreditation body may submit
copies of the arrangement in paragraph 1 of Article 2 to the
Central Competent Authority to apply for permission renewal. The
validity of the renewed permission shall not exceed 5 years.
Article 5
In case of any amendment to the permissions stipulated in
subparagraphs 1 to 3 of paragraph 1 of the previous article,
the accreditation body shall submit relevant documents to
the Central Competent Authority to apply for such amendment
permission.
Accreditation body shall apply for the amendment permission of
subparagraph 1 of paragraph 1 of the previous article from the
Central Competent Authority within 30 days after occurrence of
the event.
Article 6
Upon the accreditation body’s amendment to or abolishment
of the documents stipulated in paragraph 2 of Article 3, the
accreditation standards stipulated in subparagraph 4, paragraph
2 of Article 3 shall be submitted to the Central Competent
Authority for approval, and other documents shall be kept record
with the Central Competent Authority.
Article 7
Upon accepting the accreditation application from an
institution, school or legal entity, the accreditation body
shall sign the accreditation contract with the applicant who
is reviewed eligible according to the accreditation standards
in initial assessment procedures to provide certification
service, and shall issue the accreditation certificate to the
certification body.
The accreditation certificate in the above paragraph shall
include the following items:
1. Name and address of the certification body.
2. Name of accreditation standards.
3. Scope of accreditation and certification type.
4. Areas and countries where the certification activity is
allowed to be performed.
5. Accreditation certificate number.
6. Name of accreditation body.
7. Issuing date and valid period.
Article 8
The certification type in subparagraph 3 of paragraph 2 of the
previous article refers to individual certification and group
certification.
Non-natural person operators who meet the following conditions
can apply for group certification:
1. The management center is established to be responsible for
business planning and implementing.
2. Group members adopt the quality management system established
by the management center, continuously operate under
the supervision of the management center, and meet the
requirements and rules thereof.
3. The produced organic agricultural products and in-conversion
agricultural products are labeled and sold in the name of
the group.
Article 9
For the accredited certification body, the accreditation body
shall conduct surveillance at least once a year to ensure
that the certification body constantly meets the accreditation
standards in the valid period of the accreditation certificate.
Article 10
The valid period of the accreditation certificate of the
certification body is three years. Six months prior to
expiration, the certification body may apply for renewal
assessment; in case of an overdue application, re-application
for accreditation is required.
For the certification body that applies for renewal assessment
and is found eligible through renewal assessment procedures,
the accreditation body shall approve the renewal and issue the
accreditation certificate, provided that each renewal period
shall not exceed three years.
Article 11
The certification body may apply to the accreditation body for
an extensional assessment regarding the scope of accreditation,
and the area and country in which the accreditation activities
are performed.
For the application stipulated in the previous paragraph,
if the applicant is found eligible through extensional
assessment procedures, the accreditation body shall update the
accreditation certificate.
Article 12
If the certification body can no longer engage in its scope of
certification or certain certification activities in the area
and country, the certification body shall immediately notify the
accreditation body in writing.
After receiving the aforementioned notice, the accreditation
body shall reduce the incapacitated part of that certification
body and update the accreditation certificate.
Article 13
If the certification body is under any of the following
circumstances, the accreditation body may terminate its
certification qualification or certain scope of certification
activity:
1. Lacking the ability required for all certification activities
within the scope of the accreditation according to
accreditation standards.
2. Lacking the ability required for some certification
activities within the scope of accreditation according
to accreditation standards and failure to notify the
accreditation body as required in paragraph 1 of the
previous article.
3. Organizational functioning and perspective fail to maintain
impartiality and independence stipulated in accreditation
standards.
4. Failing to conduct certification activities in accordance
with the relevant provisions of the accredited scope in a
serious manner.
5. Its certified operator fails to meet certification standards
stipulated in paragraph 3 of Article 12 of the Act in
a serious manner and failure to subsequently handle it
effectively.
6. Failing to manage its certified operator regarding the use of
the organic mark as stipulated in paragraph 2 of Article 20
of the Act in a serious manner.
7. Engages in certification activities beyond the scope of
accreditation.
8. Provides false certification records or relevant documents in
a serious manner.
9. Other serious inconformity to accreditation standards
according to the assessment results of the accreditation body.
Article 14
Accreditation contracts signed with the certification body and
following records of the accreditation body’s engagement in
accreditation activities shall be retained for at least five
years:
1. Records of formulation, amendment, and abolishment of the
documents in paragraph 2 of Article 3.
2. Assessment records of the certification body according to
assessment process.
3. Records of the accreditation decision according to assessment
results.
4. Records regarding selecting, training, dispatching, and
appraisal of assessment personnel.
5. Other records required by the Central Competent Authority.
Article 15
Based on the engaged accreditation activities, the accreditation
body shall submit a written performance report of the previous
year to the Central Competent Authority by March 31 every year.
The Central Competent Authority may form an examination team to
conduct examination of the accreditation body and its accredited
certification body.
Article 16
The accreditation body shall disclose the name, address,
contact number, scope of accreditation, area and country of
accreditation, valid accreditation period, and information
about its disposals of its accredited certification body on the
accreditation body’s website.
Article 17
These Regulations shall enter into force on May 30, 2019.
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Appendix
Required Items for the Accreditation Standards of Accreditation
Bodies
1. Certification body
1.1 With the accreditation qualifications stipulated in the
Accreditation Requirements for Product Certification Bodies
(ISO/IEC 17065).
1.2 Conduct audit according to the Guidelines for Auditing
Management Systems (ISO 19011).
1.3 Testing required for certification shall be conducted by a
test laboratory accredited according to the General
Requirements for the Competence of Testing and Calibration
Laboratories (ISO/IEC 17025). However, for specific
test items, when a laboratory cannot completely meet the
requirements and no other laboratories have such capacity,
the accreditation body may witness how the certification
body confirms laboratory capabilities through witness
assessment.
1.4 Organizational functioning and perspective maintain
impartiality and independence.
1.5 Capable of managing the use of the organic mark by its
certified operators.
1.6 Capable of handling businesses and issues between and among
the Central Competent Authority, the accreditation body,
the certification applicant, its certified operator, and
consumers.
1.7 Capable of training and appraising its personnel to meet
basic personnel requirements.
1.8 Starting from the date of the accreditation application,
the accreditation qualifications have not been terminated by
the accreditation body within the last three years.
1.9 Contents of the certification contract shall meet the
Items Required to be Stated in the Contract between Organic
Certification Bodies and Agricultural Operators stipulated
by Central Competent Authority.
2. Basic personnel requirements
2.1 Certification auditor
2.1.1 Shall meet one of the following qualifications:
2.1.1.1 Passed the relevant national occupational test.
2.1.1.2 With work experience in the production, processing,
research, development, technology, transportation and
sale, test, and quality management of agricultural products
(crops, livestock products, aquatic products, forest
products, processed products), or in the formulation
(establishment), amendment, or review of relevant standards
or regulations.
2.1.1.2.1 If graduated from an agriculture and food-related
department: one year.
2.1.1.2.2 If not graduated from an agriculture and food-related
department: two years.
2.1.2 Shall obtain a certificate of qualifying conformity
assessment training for auditors and have experience
participating in at least five on-site audits according
to the category of agricultural products (crops, livestock
products, aquatic products, forest products, processed
products), which shall be accomplished within two years
before obtaining auditor qualifications.
2.1.3 Shall undergo the following training and obtain the
corresponding certificates:
2.1.3.1 At least eight hours of training on the applicable
laws of organic agricultural products and domestic and
foreign certification systems.
2.1.3.2 At least 16 hours of training on knowledge related to
the processes and technologies for the production, storage
and distribution of agricultural products.
2.1.3.3 At least 16 hours of training on audit skills, methods
and case analysis.
2.1.4 The training participation stipulated in 2.1.3 shall be
limited to the following:
2.1.4.1 Training held by the Central Competent Authority and its
affiliated body.
2.1.4.2 Training held by an institution entrusted by the Central
Competent Authority.
2.1.4.3 Training held by institutions of college.
2.1.4.4 Training held by a professional institution approved by
the Central Competent Authority.
2.1.5 If not graduated from an agriculture and food-related
department, the hours of training received according to
2.1.3 shall be no less than 60 hours.
2.1.6 An eligible auditor shall receive at least 20 hours of
advanced training every two years, whose contents are the
same as those stipulated in 2.1.3, and at least 10 on-site
audits shall be conducted to maintain qualification.
2.1.7 For the number of on-site audit stipulated in 2.1.2 and
2.1.6, if the number of on-site audit on the specific
category of agricultural products cannot be accomplished due
to special circumstances, the number thereof may be reduced
with the Central Competent Authority’s consent.
2.2 Certification decision maker
2.2.1 Knowledgeable about regulations related to organic
agriculture.
2.2.2 Knowledgeable about certification body operating
procedures and scopes of certification activity.
2.2.3 Knowledgeable about audit principles and techniques.
2.2.4 With more than three years of cumulative experience
in fields related to organic agriculture, the production
or certification of organic agricultural products, or
assessment of accreditation body.
3. Basic certification criteria
3.1 Certification procedure and operation period
3.1.1 Upon accepting an application for the certification of
organic agricultural products and in-conversion agricultural
products, the certification body shall carry out the
procedures of the document review, on-site audit, product
sampling for testing and certification decision, and the
applicant shall be notified of the results in writing.
However, if according to risk assessment or no products are
available for testing due to the factor of force majeure,
the certification body may test other part of the plant
thereof.
3.1.2 The certification body shall determine the operation
period of each procedural stage stipulated in 3.1.1, and the
duration of the operation periods of all stages shall not
exceed six months. However, this period shall not include
the time period to make corrections or improvements notified
to the applicant.
3.2 Group certification
3.2.1 For a group certification application case, prior to on-
site audit, the certification body shall first evaluate
whether the operation of its management center meets
the requirements of its own regulations and operating
procedures; if the results indicate that sampling may be
applicable for the following on-site audit, the number of
members sampled shall be no less than the square root of the
total number of members.
3.2.2 If sampling is adopted for on-site audit of group members
according to 3.2.1, the certification body shall audit all
lands of the sampled members that applied for certification.
3.2.3 When the certification body conducts product sampling for
testing in a group certification case, the number of
sampling for testing thereof shall be no less than the
square root of the total number of members.
3.3 For the sampling carried out by the certification body, the
procedure and quantity thereof shall give consideration to
the objectivity, representativeness, and purpose of risk
management and be capable of avoiding contamination.
3.4 Certification certificate
3.4.1 For those who apply for organic agricultural products and
in-conversion agricultural products certification and are
found eligible through certification, the certification
body will issue the certification certificate for organic
agricultural products and in-conversion agricultural
products according to the relevant product categories.
3.4.2 The certification certificate shall include the following
items:
3.4.2.1 The name and address of the operator, and the name of
its statutory person responsible.
3.4.2.2 Address or land number of the certification site.
3.4.2.3 Category and item of agricultural products and
certification type thereof.
3.4.2.4 Valid period.
3.4.2.5 Name and address of the certification body.
3.4.2.6 Certificate number.
3.4.3 The validity period of a certification certificate for
organic agricultural products and in-conversion agricultural
products shall be no more than three years; three months
prior to expiration of the valid period, the certification
body shall ask the operator to fill in the application form
to apply to the certification body for renewal; overdue
renewal applications shall not be accepted.
3.4.4 After the renewal application according to 3.4.3 has been
reviewed and approved, the certification certificate will be
renewed.
3.5 Amendment to certification certificate
3.5.1 If an operator has any of the following circumstances,
the certification body shall ask it to submit relevant
materials to apply for the amendment to the certificate of
organic certification or in-conversion certification:
3.5.1.1 Change of the name or address of the operator, or the
name of its statutory person responsible.
3.5.1.2 The certification scope is reduced in terms of the
certified site or certified product items.
3.5.1.3 Reduction of group certification members.
3.5.2 After the application according to 3.5.1 has been reviewed
and approved, a replacement certificate with the same period
of validity as the original certificate shall be issued.
3.6 Report to the certification body for review
3.6.1 If changes are made to the production and processing of
organic agricultural products and in-conversion agricultural
products, or in the operating system maintaining organic
integrity, the operator shall take the initiative to report
such changes to the certification body for review.
3.6.2 If the certification body reviews the change and
determines that it is likely to affect the results of the
original certification, the certification shall be conducted
on the change by the certification body.
3.7 Application for extensional audit
3.7.1 Under any of the following circumstances, the
certification body shall ask the operator to submit relevant
materials to apply for extensional audit:
3.7.1.1 An extension of the certification site.
3.7.1.2 An extension of the agricultural product items to be
certified.
3.7.1.3 An extension of group certification members.
3.7.2 After the extensional audit according to 3.7.1 has been
reviewed and approved, a replacement certificate with the
same period of validity as the original certificate shall be
issued.
3.8 Surveillance
3.8.1 The certification body shall perform surveillance on all
of its operators with the certified products at least
once a year. However, the frequency of surveillance may be
increased as necessary.
3.8.2 For the surveillance conducted by the certification body
according to 3.8.1, the proportion of surveillance
without notice or by serving notice within 24 hours before
surveillance shall account for at least five percent of the
total number of its certified operators.
3.9 The procedures prescribed in 3.1.1 shall apply mutatis
mutandis to the renewal audit stipulated in 3.4.3, the
review and certification stipulated in 3.6, the extensional
audit stipulated in 3.7.1 and the surveillance audit
stipulated in 3.8.1, the certification body shall refer
to procedures, or the certification body may implement
necessary procedures in view of the certification risk of
the individual case.
3.10 The certification body shall conduct sample testing of its
certified agricultural products in the market every year,
and the number thereof shall account for at least three
percent of the total number of its certified operators.
3.11 The certification body shall publish relevant information
of its certified operators, such as the name, address,
contact number, categories and items of certified
agricultural products, valid period and disposals in the
information system designated by the Central Competent
Authority within 10 days after making a certification
decision or reviewing, as well as quarterly publish the
relevant information on issuing organic marks in the same
system.
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