Legislative history
1. Full text of 4 items was promulgated by the Council of
Agriculture on June 5, 2019 per Order Nung-Liang-Tzu-Tze
1081069322A.
1 Definitions of terms used in this Contract:
1.1 Production place: premises involved in the production,
processing, packaging, or distribution of organic
agricultural products or in-conversion agricultural
products.
1.2 Surveillance: an audit performed by the certification body
to verify that the certified operator keep complying with
the certification standards within the valid certification
period.
1.3 Renewal audit: an audit conducted by a certification body
before the valid certification period ends to determine
whether a certified operator may maintain its certified
status.
1.4 Extensional audit: an audit conducted by a certification
body to determine whether a certified operator may extend
its certification scope within the valid certification
period.
1.5 Certification standards, categories, and items of
agricultural products: the certification standards,
categories, and items of agricultural products established
by the Central Competent Authority in accordance with
paragraph 3 of Article 12 of Organic Agriculture Promotion
Act (hereinafter referred to as the Act).
1.6 Operator: a natural person; a farm, ranch, aquafarm,
organization, agricultural production and marketing group
incorporated or registered pursuant to law; a legal entity
obtaining a company license or business registration
certificate; an authority (institution), school, or legal
entity.
1.7 Group certification: the group certification stipulated in
Regulations for Approving and Supervising Organic
Accreditation Bodies.
2 Certification application stage
2.1
2.1.1 The documents below shall be submitted by the operator
applying for the certification:
2.1.1.1 Documents to prove that the Applicant is a qualified
operator.
2.1.1.2 Information about the geographical location of the
production place.
2.1.1.3 Production plan or process description subject to the
certification standards. The operators subcontracting others
to produce, process, package, distribute, or sell products
shall submit the subcontracting production plan or process
description.
2.1.1.4 Records and documents related to the maintenance of its
organic operation system.
2.1.1.5 Other documents required by the Central Competent
Authority or certification body.
2.1.2 Records and documents related to the maintenance of the
organic operation system as stipulated in 2.1.1.4 include:
2.1.2.1 Operation records.
2.1.2.2 Ingredient and material procurement and inventory
records.
2.1.2.3 Product production and sale records.
2.1.2.4 Management records of production land, facility, and
environment.
2.1.2.5 Certification history.
2.1.2.6 Customer complaint records.
2.1.2.7 An operator applying to multiple certification bodies
for certification shall also submit the self-management
mechanism and relevant records.
2.1.3 Operators applying for group certification shall also
submit the following documents to the certification body for
application:
2.1.3.1 Supporting documents regarding the contractual or other
legal relations between and among all members and the
management center.
2.1.3.2 Quality management system documents, relevant operating
procedures, and execution records of the management center.
2.1.3.3 Records of at least one round of self-audit on the
management center.
2.1.3.4 Records of at least one internal inspection conducted by
the management center on all members.
2.2 Certification procedure and operation period of each
procedural stage carried out by certification body shall
include:
2.2.1 Certification procedures shall include documents 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. If considered necessary,
the certification body may sample a proper quantity of
materials or substances used by the operators for testing
purposes.
2.2.2 The certification body shall determine the operation
period of each procedural stage, and the total duration of
the operations shall not exceed six months. However, this
period shall not include the time period to make corrections
or improvements notified to the applicant.
2.2.3 The way to handle the issues caused by exceeding the
time limit of the aforesaid operation period due to reasons
attributable to the certification body.
2.2.4 The certification body is exempted from paying for the
products, materials or substances sampled for testing,
and shall conduct sampling for testing according to the
accreditation standards approved by the Central Competent
Authority pursuant to subparagraph 2 of paragraph 4 of
Article 11 of the Act.
2.3 The reasons for rejecting application for certification
shall include the following items:
2.3.1 The production, processing, packaging, or distribution
process of the agricultural products applying certification
does not comply with the certification standards, and such
non-compliances are critical.
2.3.2 Where the percentage of organic and in-conversion
ingredients of the respective agricultural products applying
for certification accounts for less than 95 %.
2.3.3 Where the on-site audit cannot be conducted within six
months after the document review due to reasons attributable
to the applicant.
2.3.4 Where the applicant, without good cause shown, fails to
make corrections or improvements within the given time limit
notified by the certification body;
2.3.5 Where the test result indicates the product contains
prohibited substances.
2.3.6 False documents or information is provided that can result
in serious consequences.
2.3.7 Where the certification procedure cannot be completed
within a one-year period after the date of accepting the
application for reasons attributable to the applicant.
2.3.8 Within one year after the certified status is terminated
by the certification body due to the violation of the Act.
3 Post-certification stage:
3.1
3.1.1 Circumstances under which an operator shall take the
initiative to apply to the certification body for an
amendment to the certificate of organic certification or in-
conversion certification include the following:
3.1.1.1 Change of the name or address of the operator, or the
name of its statutory person responsible.
3.1.1.2 The certification scope is reduced in terms of the
certified site or certified product item.
3.1.1.3 Reduction of group certification members.
3.1.2 After the relevant materials have been submitted and
the application in the previous paragraph has been
reviewed and approved, the certification body shall issue a
replacement certificate with the same period of validity as
the original certificate.
3.2
3.2.1 Circumstances under which operators shall take the
initiative to apply to the certification body for review
include changes in the production process of organic
agricultural products and in-conversion agricultural
products, or changes in the operating system maintaining
organic integrity as well as the subcontracting production
process.
3.2.2 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.
3.3
3.3.1 Circumstances under which an operator shall take the
initiative to apply to the certification body for an
extensional audit include the following:
3.3.1.1 An extension of certification site.
3.3.1.2 An extension of agricultural product items to be
certified.
3.3.1.3 An extension of group certification members.
3.3.2 When an operator submits relevant materials to apply for
and has passed the extensional audit stipulated in the
previous paragraph, the certification body shall issue a
replacement certificate with the same period of validity as
the original certificate.
3.4 Regarding the use of certificate for organic agricultural
products and in-conversion agricultural products, it shall
include being non-transferable to others; however, when a
duplicate copy needs to be provided, it shall include all
contents of the certificate.
3.5
3.5.1 For first-time applicant, the validity period of
certification certificate for organic agricultural products
and in-conversion agricultural products shall be no more
than three years from application date. Three months prior
to the expiration of validity period, the operator may fill
in an application form to apply to the certification body
for renewal audit; overdue renewal applications shall not be
accepted.
3.5.2 After the renewal application according to the previous
paragraph has been reviewed and approved, the certification
body will issue a replacement certificate. The validity
period shall be counted from the day after the expiration of
the original valid period and be no more than three years.
3.6
3.6.1 The frequency of the surveillance on operators by the
certification body shall be no less than once a year and may
be increased if necessary.
3.6.2 The surveillance conducted by the certification body
according to the previous paragraph may be conducted without
notice or by serving notice to the operator within twenty-
four hours before surveillance, and the operator shall not
refuse without good cause.
3.7 The periods that operators must retain relevant operational
records and documents regarding the maintenance of product’s
organic integrity are as follows:
3.7.1 One year for fresh agricultural products.
3.7.2 If the product’s label indicates an expiration date, one
year after the expiration date.
3.7.3 Five years for other products.
3.8 Reasons for the termination of certification by the
certification body shall include the following:
3.8.1 The operator fails to keep conforming to the relevant
provisions of the certification standards or certification
contract in a serious manner, or fails to make correction
within the time limit required by the certification body.
3.8.2 The operator refuses, evades, or impedes the surveillance
by the certification body.
3.8.3 The operator provides false documents or information that
has serious consequences.
3.8.4 The contents of an advertisement published by the operator
are inconsistent with the certified contents in a serious
manner.
4 Others
4.1 Operators shall cooperate with relevant matters when
the certification body is conducting the initial audit,
surveillance, renewal audit, extensional audit or product
sampling; the statutory person responsible or relevant
personnel of the place being audited shall accompany the
audit and shall sign or stamp on the record made by the
certification body after work is completed.
4.2 The certification procedures in 2.2 shall apply mutatis
mutandis to the procedures of reviewing and certification
stated in 3.2.2, the extensional audit stated in 3.3.1, the
renewal audit stated in 3.5.1 and the surveillance stated
in 3.6.1. The certification body shall thereby implement
necessary procedures after assessing the certification risk
of an individual case.
4.3 The labeling, usage, suspension of usage and relevant
management of organic marks.
4.4 Calculation of compensation for damages to the operator
certified by the certification body due to the termination
of its accreditation qualification in whole or in part by
the accreditation body.
4.5 Calculation of compensation for the leak of operator’s
confidential technical production information or trade
secrets that the certification body learns through
certification activities.
