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Decision 562
Directives for the preparation, adoption and
application of Technical Regulations in
Andean Community Member Countries and at
community level
THE ANDEAN
COMMUNITY COMMISSION
HAVING
REVIEWED: Articles 51, 55, 72 and 73 of the
Cartagena Agreement and Decisions 376, 419
and 506; and,
WHEREAS:
Articles 32 and 33 of the Andean
Standardization, Accreditation, Testing,
Certification, Technical Regulations and
Metrology System, approved by Decisions 376
and 419 of the Andean Community, prescribe
the obligation of Member Countries to notify
any proposals involving new Technical
Regulations, Mandatory Technical Standards,
compliance evaluation procedures, mandatory
certifications and any other equivalent
mandatory measure which may be adopted, at
least ninety (90) days prior to the
application of such measures to the trade of
products in the subregion, with such notice
being a prior requirement for enforcing
compliance;
Decision 506
concerning recognition and acceptance of
certificates for products traded in the
Andean Community, regulates the automatic
recognition and acceptance by the Member
Countries, of compliance certificates for
products subject to Technical Regulations or
Technical Standards of mandatory compliance
in the destination country, issued by
accredited or recognized certification
organizations;
According to
paragraphs 2.9.2, 2.10.1, 5.6.2 and 5.7.1 of
the World Trade Organization’s Agreement on
Technical Barriers to Trade (WTO - TBT), WTO
Members must notify the other Members in a
conveniently early stage (when changes could
still be made), of any proposals involving
Technical Regulations and compliance
evaluation procedures when their technical
contents do not comply with pertinent
international standards, provided that such
regulations or compliance evaluation
procedures do have a significant effect on
the trade of other Members;
In addition,
the World Trade Organization’s Agreement on
Technical Barriers to Trade (WTO - TBT)
establishes the international legal
framework for the preparation, adoption and
application of the Technical Regulations;
The Technical
Regulations are prepared, adopted and
applied in the Andean Community Member
Countries by the various central, regional,
departmental, local or municipal government
organizations, or by several of them, within
the jurisdiction of their respective
competence;
It is
necessary to guarantee that the Technical
Regulations prepared, adopted and applied by
the central, regional, departmental, local
or municipal government organizations in the
Member Countries will not become unnecessary
barriers to trade in the subregion;
The 11th
Andean Presidential Council held in
Cartagena de Indias, Colombia, in May 1999,
instructed the Andean Community Commission
so that, with the support of the General
Secretariat, it will set off the necessary
efforts aimed at achieving the progress
needed for mutual recognition and
harmonization of Technical Standards;
DECIDES:
To approve the
following Decision containing the Directives
for the preparation, adoption and
application of Technical Regulations in
Andean Community Member Countries and at the
community level.
CHAPTER I
OBJECTIVES
Article
1.-
The objective of this Decision is to
establish requirements and procedures for
the preparation, adoption and application of
Technical Regulations within the Member
Countries and at the community level, in
order to prevent them from becoming
unnecessary technical barriers to trade in
the subregion.
CHAPTER II
SCOPE,
APPLICATION AND DEFINITIONS
Article
2.-
This Decision sets forth the Andean legal
framework for the preparation, adoption and
application of Technical Regulations by the
Member Countries, through entities of
central, regional, departmental, local or
municipal governments, and by the Andean
Community Commission, without detriment to
any provisions issued to that effect by the
Cartagena Agreement itself.
Article
3.- The
stipulations of this Decision are applicable
to the preparation, adoption and application
of Technical Regulations of products from
all sectors, as well as to the processes
related to the manufacture of products as
long as they affect the final
characteristics, except for any health,
phytosanitary or other measures regulated by
a specific Decision.
Article
4.-
For the purposes of the application of this
Decision, the following definitions shall be
used:
Technical
Regulations.- A
document setting forth the characteristics
of a product or the production processes and
methods related thereto, including any
applicable administrative provisions of a
mandatory nature. It may also include
prescriptions with regard to terminology,
symbols, packing, marking or labeling
applicable to a product, process or method
of production, or deal exclusively therewith.
Within the
scope of this definition, Technical
Regulations include any Technical Standards
declared mandatory, and any other equivalent
measure of a mandatory nature which may have
been adopted or which will be adopted by any
of the Member Countries.
Emergency
Technical Regulations.-
A document adopted to deal with any problems
or potential problems which may affect
safety, public health, environmental
protection or national security.
Andean
Technical Regulations.-
A document adopted by Decision of the Andean
Community Commission.
Compliance
Certificate.- A
document issued in accordance with the rules
of a certification system, upon which one
can reasonably rely that a properly
identified product, process or service
complies with certain Technical Regulations,
Technical Standards or other technical
specification or specific regulatory
document.
Compliance
evaluation procedure.-
Any procedure directly or indirectly used to
determine that prescriptions pertaining to
Technical Regulations and Technical
Standards are complied with.
Compliance
evaluation procedures include, among others,
sampling, testing and inspection; evaluation,
verification and certification of compliance;
registration, accreditation and approval,
separately or through different combinations.
Technical
Standards.- A
document approved by a recognized
institution which provides, for common and
repetitive use, rules, directives or
characteristics for products or related
production processes and methods, which are
not of mandatory compliance. They may also
include prescriptions in matters relating to
terminology, symbols, packing, marking or
labeling applicable to a product, production
process or method, or deal exclusively
therewith.
Legitimate
Objectives.- These
are imperatives for public morality,
national security, protection to life and
human, animal and vegetable health, defense
of consumers and environmental protection.
CHAPTER III
GENERAL
PRINCIPLES
Article
5.-
The
preparation, adoption and application of
Technical Regulations in the Andean
Community Member Countries and at the
community level shall be governed by
principles of national treatment, most
favored nation, non-discrimination,
equivalence and transparency, established in
the Andean Community legislation and
complementary provisions, within the
framework of the World Trade Organization.
CHAPTER IV
GENERAL
REQUIREMENTS AND CRITERIA FOR THE ADOPTION
OF
NATIONAL
TECHNICAL REGULATIONS
Article
6.- The Technical
Regulations shall not restrict trade more
than what is necessary to achieve a
legitimate objective, taking into account
the risks implied in not achieving it,
choosing between the possible options those
which generate lower implementation and
compliance costs for the users and for trade
in the subregion.
Article
7.- The Technical
Regulations shall be defined exclusively on
the basis of use and utilization properties
of the products to which they refer, rather
than on their descriptive or design
characteristics.
Article
8.-
In the process for the
preparation and adoption of Technical
Regulations, Member Countries shall work on
the basis of the international standards or
their pertinent elements or such
international standards which approval is
imminent, except in the case where such
international standards or pertinent
elements are an ineffective or inappropriate
mean for the achievement of the legitimate
objectives pursued, for example as a result
of fundamental climatic or geographical
factors or limitations or problems of a
technologic nature justifying the use of
different criteria.
In the latter
case, National Technical Regulations will be
based on Andean subregional, regional and/or
national regulations.
CHAPTER V
CONTENTS OF
TECHNICAL REGULATIONS
Article
9.- Any Technical
Regulations prepared, adopted and applied
hereunder must include the followings
aspects:
1.
Purpose.- Indicate the object of
the Technical Regulations and the
legitimate objectives to be protected,
identifying the risks which prevention is
sought.
2.
Field of application.- Products
included therein, indicating the NANDINA
Customs Subheading.
3.
Specific Technical Contents of the
Regulations.- This must cover, as
applicable, the followings aspects:
a)
Definitions: Those necessary for the
adequate interpretation of the Technical
Regulations.
b)
General Conditions: Description of
the general characteristics of the
product, such as odor, color, appearance,
aspect, presentation, previous processes,
limits and others, as well as the
required characteristics of the
production process or method related to
the product.
c)
Requirements: Expressly establish
the technical specifications that should
be met by a product, production process
or method related thereto.
d)
Container, packing and marking or
labeling requirements: Establish the
necessary technical specifications for
containers or packing suitable for the
use and utilization of the product, as
well as the information which must be
included with the product, including its
contents or quantity.
e)
Reference: Whenever reference is
made to one or several Technical
Standards, in whole or in part, it must
indicate the version to which it
corresponds and be made available to the
interested parties by the entity issuing
the Technical Regulations.
4.
Administrative Procedure.- The
administrative procedure through which the
application of the Technical Regulations
is effectively implemented (including the
compliance evaluation procedures) must be
properly specified. This must include a
clear description of the procedure (preferably
using flow charts), related legal basis,
forms, records, authorities responsible
and other elements which will allow its
use in a transparent and non-discriminatory
manner. The legal basis must indicate the
date of issue, date of publication and
effective date.
5.
Effective Date.- The term between
the publication of the Technical
Regulations and their effective date may
not be less than six (6) months, except
when it is not possible to achieve the
legitimate objectives persued.
6.
Organizations responsible for
compliance evaluation.- The accredited
or recognized entities responsible for
compliance evaluation (test laboratories,
calibration laboratories, certification
organizations or inspection entities) must
be properly indicated. In addition, it
should include the name of the
organization responsible for supplying
updated information concerning such
entities.
7.
Inspection and/or Supervision Authority .-
The name of the national, regional,
departmental, local or municipal authority
competent to supervise compliance with the
Technical Regulations must be specified.
8. Type
of inspection and/or supervision.-
There must be an indication as to whether
the inspection or the supervision will be
performed prior to import and sale of the
product or once its placement in the
market has been confirmed.
9.
Sanctions System.-
Specification of the sanctions and legal
procedures to be applied for non-compliance
with the provisions of the Technical
Regulations.
CHAPTER VI
NOTICE,
ISSUANCE, REGISTRATION AND REVIEW OF
TECHNICAL REGULATIONS
Article
10.-
Member Countries must make sure that the
draft Technical Regulations they plan on
adopting are published in the Official
Gazette, Official Newspaper or other
newspaper of national circulation, or in
electronic media, simultaneously to the
publication of the notice prescribed in
Article 11 of this Decision.
Article
11.-
Notwithstanding the stipulations of Article
16 hereof, Member Countries shall notify the
rest of the Member Countries, through the
Andean Community’s General Secretariat, of
the draft Technical Regulations they are
planning on adopting, at least ninety (90)
calendar days prior to official publication
thereof. A notice given within the
prescribed term will be a necessary
requirement to be able to demand compliance
by the other Member Countries.
The procedures
to be used for notices shall be those
established in the community legislation and
those prescribed in the World Trade
Organization’s Agreement on Technical
Barriers to Trade (WTO - TBT), and any
supplements and amendments thereto.
In all cases,
when adopting or applying the measure, the
notifying Member Country must take into
account the observations and results of any
inquiries made, provided they are properly
substantiated.
Article
12.- Member
Countries shall deliver their notices to the
Andean Community’s General Secretariat or to
the corresponding entities using the Notices
Form adopted to this effect by the World
Trade Organization.
Article
13.- Within the
first five (5) days of each month, the
Member Countries’ National Information
Services must forward to the Andean
Community’s General Secretariat, a monthly
list of any Technical Regulations which may
have come into effect during the preceding
month, for incorporation in the Andean
Information Center’s data base.
If on its own
initiative or on request, the General
Secretariat finds that any of the Technical
Regulations represents an unjustified
barrier to trade, which is not in accordance
with this Decision and with Article 71 of
the Cartagena Agreement, it shall start off
the corresponding procedures within the
scope of the provisions contained in Article
73 of the same Agreement.
Article
14.-
Notwithstanding the stipulations of the
previous article, any Member Country or
private party feeling affected by the
application of any Technical Regulations,
may start a summary proceeding for dispute
settlement, as referred to in Article 8 of
the Andean Standardization, Accreditation,
Testing, Certification, Technical
Regulations and Metrology System, approved
by Decisions 376 and 419 of the Andean
Community.
Article
15.- Member
Countries shall not maintain Technical
Regulations if the circumstances or
objectives which called for their adoption
no longer exist, or if the circumstances or
objectives have changed and could be taken
care of in a manner which is less
restrictive to trade.
CHAPTER VII
EMERGENCY
TECHNICAL REGULATIONS
Article
16.-
In cases of emergency, the entities of
Member Countries that are subject to this
Decision may adopt Technical Regulations
without regard to the term prescribed in
Article 11. In such cases, the Member
Country adopting the measure must notify the
Andean Community’s General Secretariat,
within twenty-four (24) hours following
their issuance, and the latter must in turn
notify the other Member Countries within
twenty-four (24) hours following receipt of
the respective notice.
In any event,
the Member Country applying the measure must
grant the other Member Countries, without
discrimination, the possibility to make
written observations, make inquiries about
them, if so requested, taking into account
such written observations and the results of
such inquiries provided they are duly
substantiated. The notifying country shall
inform of the results of the consultation to
the Andean Community’s General Secretariat.
When the
emergency is over, and, in any case, within
a term not to exceed twelve (12) months
following the issuing of an emergency
measure, the Member Country which applied
such measure must revoke it. If an
additional term is required, provided it is
properly substantiated, it may extend the
measure only once, by a term not to exceed
six (6) months at the most. Prior to the end
of any of such terms, and if it is in the
country’s best interest, and the measure is
justified, the country may convert it into a
Technical Regulation, following the
procedure outlined in Chapter VI.
Notwithstanding the provisions stipulated in
the foregoing paragraphs, if the measure
applied was considered by the General
Secretariat o any Member Country as an
unjustified restriction to trade, the
corresponding investigations shall begin,
pursuant to the provisions of Article 73 of
the Cartagena Agreement.
CHAPTER
VIII
ANDEAN
TECHNICAL REGULATIONS
Article
17.-
The
Technical Regulations approved by the Andean
Community Commission must abide by the
provisions stipulated in Chapter V of this
Decision.
Article
18.- The
Commission shall approve any Technical
Regulations it may deem necessary, by means
of a Decision, on the proposal of the
General Secretariat and subject to the prior
opinion of the Andean Standardization,
Accreditation, Testing, Certification,
Technical Regulations and Metrology
Committee, and when applicable, of the
competent Specialized Technical Committee,
depending on the prescribing standard.
CHAPTER IX
ANDEAN
INFORMATION CENTER ON STANDARDS,
TECHNICAL REGULATIONS AND COMPLIANCE
EVALUATION PROCEDURES
Article
19.- The “Andean
Information Center on Standards, Technical
Regulations and Compliance Evaluation
Procedures” is hereby created to provide
information and deal with any inquiries
arising from the preparation, adoption and
application of Technical Regulations in the
Member Countries and in the Andean Community,
and to contribute towards a swift and safe
management of the trade of products subject
to compliance with Technical Regulations.
The “Andean
Information Center on Standards, Technical
Regulations and Compliance Evaluation
Procedures” shall be comprised of the
National Information Services of the Member
Countries and the corresponding service of
the General Secretariat.
CHAPTER X
TEMPORARY
PROVISIONS
Article
20.-
Within a term of one year as from the
effective date of this Decision, the Member
Countries shall implement the “Andean
Information Center on Standards, Technical
Regulations and Compliance Evaluation
Procedures”, created pursuant to Article 19
above.
Article
21.- Within a term
of thirty (30) calendar days counted as from
the effective date of this Decision, the
Member Countries must notify the General
Secretariat of their National Information
Services, pursuant to Article 19 of this
Decision.
CHAPTER XI
FINAL
PROVISIONS
One.-
Articles 32 and 36 of Decision 376 of the
Andean Community Commission are hereby
repealed, since Decision 376 was amended by
Decision 419 of the Andean Community
Commission.
Two.-
The followings items contained in Annex II
of Decision 376 are hereby amended as
follows:
-
Compliance Certificate.- A document
issued in accordance with the rules of a
certification system, upon which one can
reasonably rely that a properly
identified product, process or service
complies with certain Technical
Regulations, Technical Standards or
other technical specification or
specific regulatory document.
-
Technical Standard.- A document
approved by a recognized institution
which provides, for common and
repetitive use, rules, directives or
characteristics for products or related
production processes and methods, which
are not of mandatory compliance. They
may also include prescriptions in
matters relating to terminology, symbols,
packing, marking or labeling applicable
to a product, process or method of
production, or deal exclusively
therewith.
-
Technical Regulations.- A
document setting forth the
characteristics of a product or the
production processes and methods related
thereto, including any applicable
administrative provisions of a mandatory
nature. It may also include
prescriptions with regard to terminology,
symbols, packing, marking or labeling
applicable to a product, process or
method of production, or deal
exclusively therewith.
Within the
scope of this definition, Technical
Regulations include any Technical
Standards declared mandatory, and any
other equivalent measure of a mandatory
nature which may have been adopted or
which will be adopted by any of
the Member Countries.
Given in
Recinto Quirama, Department of Antioquia,
Republic of Colombia, on June 25, 2003.
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