Article 12: Administration back to top
1.
A Committee on Sanitary and Phytosanitary Measures is hereby
established to provide a regular forum for consultations. It
shall carry out the functions necessary to implement the provisions of
this Agreement and the furtherance of its objectives, in particular
with respect to harmonization. The Committee shall reach its
decisions by consensus.
2.
The Committee shall encourage and facilitate ad hoc consultations
or negotiations among Members on specific sanitary or phytosanitary
issues. The Committee shall encourage the use of international
standards, guidelines or recommendations by all Members and, in this
regard, shall sponsor technical consultation and study with the
objective of increasing coordination and integration between
international and national systems and approaches for approving the
use of food additives or for establishing tolerances for contaminants
in foods, beverages or feedstuffs.
3.
The Committee shall maintain close contact with the relevant
international organizations in the field of sanitary and phytosanitary
protection, especially with the Codex Alimentarius Commission, the
International Office of Epizootics, and the Secretariat of the
International Plant Protection Convention, with the objective of
securing the best available scientific and technical advice for the
administration of this Agreement and in order to ensure that
unnecessary duplication of effort is avoided.
4.
The Committee shall develop a procedure to monitor the process of
international harmonization and the use of international standards,
guidelines or recommendations. For this purpose, the Committee
should, in conjunction with the relevant international organizations,
establish a list of international standards, guidelines or
recommendations relating to sanitary or phytosanitary measures which
the Committee determines to have a major trade impact. The list
should include an indication by Members of those international
standards, guidelines or recommendations which they apply as
conditions for import or on the basis of which imported products
conforming to these standards can enjoy access to their markets.
For those cases in which a Member does not apply an international
standard, guideline or recommendation as a condition for import, the
Member should provide an indication of the reason therefor, and, in
particular, whether it considers that the standard is not stringent
enough to provide the appropriate level of sanitary or phytosanitary
protection. If a Member revises its position, following its
indication of the use of a standard, guideline or recommendation as a
condition for import, it should provide an explanation for its change
and so inform the Secretariat as well as the relevant international
organizations, unless such notification and explanation is given
according to the procedures of Annex B.
5.
In order to avoid unnecessary duplication, the Committee may decide,
as appropriate, to use the information generated by the procedures,
particularly for notification, which are in operation in the relevant
international organizations.
6.
The Committee may, on the basis of an initiative from one of the
Members, through appropriate channels invite the relevant
international organizations or their subsidiary bodies to examine
specific matters with respect to a particular standard, guideline or
recommendation, including the basis of explanations for non-use given
according to paragraph 4.
7.
The Committee shall review the operation and implementation of this
Agreement three years after the date of entry into force of the WTO
Agreement, and thereafter as the need arises. Where appropriate, the
Committee may submit to the Council for Trade in Goods proposals to
amend the text of this Agreement having regard, inter alia,
to the experience gained in its implementation.
Article 13:
Implementation back to top
Members are fully responsible under this Agreement for the observance
of all obligations set forth herein. Members shall formulate and
implement positive measures and mechanisms in support of the
observance of the provisions of this Agreement by other than central
government bodies. Members shall take such reasonable measures
as may be available to them to ensure that non-governmental entities
within their territories, as well as regional bodies in which relevant
entities within their territories are members, comply with the
relevant provisions of this Agreement. In addition, Members
shall not take measures which have the effect of, directly or
indirectly, requiring or encouraging such regional or non-governmental
entities, or local governmental bodies, to act in a manner
inconsistent with the provisions of this Agreement. Members
shall ensure that they rely on the services of non-governmental
entities for implementing sanitary or phytosanitary measures only if
these entities comply with the provisions of this Agreement.
Article 14:
Final Provisions back to top
The least-developed country Members may delay application of the
provisions of this Agreement for a period of five years following the
date of entry into force of the WTO Agreement with respect to their
sanitary or phytosanitary measures affecting importation or imported
products. Other developing country Members may delay application of
the provisions of this Agreement, other than paragraph 8 of
Article 5 and Article 7, for two years following the date of entry
into force of the WTO Agreement with respect to their existing
sanitary or phytosanitary measures affecting importation or imported
products, where such application is prevented by a lack of technical
expertise, technical infrastructure or resources.
1.
Sanitary or phytosanitary measure — Any measure applied:
(a)
to protect animal or
plant life or health within the territory of the Member from risks
arising from the entry, establishment or spread of pests, diseases,
disease-carrying organisms or disease-causing organisms;
(b)
to protect human or
animal life or health within the territory of the Member from risks
arising from additives, contaminants, toxins or disease-causing
organisms in foods, beverages or feedstuffs;
(c)
to protect human life
or health within the territory of the Member from risks arising
from diseases carried by animals, plants or products thereof, or from
the entry, establishment or spread of pests; or
(d)
to prevent or limit
other damage within the territory of the Member from the entry,
establishment or spread of pests.
Sanitary
or phytosanitary measures include all relevant laws, decrees,
regulations, requirements and procedures including, inter alia, end
product criteria; processes and production methods;
testing, inspection, certification and approval procedures;
quarantine treatments including relevant requirements associated with
the transport of animals or plants, or with the materials necessary
for their survival during transport; provisions on relevant
statistical methods, sampling procedures and methods of risk
assessment; and packaging and labelling requirements directly
related to food safety.
2.
Harmonization — The establishment, recognition and application of
common sanitary and phytosanitary measures by different Members.
3.
International standards, guidelines and recommendations
(a)
for food safety, the standards, guidelines and recommendations
established by the Codex Alimentarius Commission relating to food
additives, veterinary drug and pesticide residues, contaminants,
methods of analysis and sampling, and codes and guidelines of hygienic
practice;
(b)
for animal healthand
zoonoses, the standards, guidelines and recommendations developed
under the auspices of the International Office of Epizootics;
(c)
for plant health, the international standards, guidelines and
recommendations developed
under the auspices of the Secretariat of the International Plant
Protection Convention in cooperation with regional organizations
operating within the framework of the International Plant Protection
Convention; and
(d)
for matters not covered by the above organizations, appropriate
standards, guidelines and recommendations promulgated by other relevant
international organizations open for membership to all Members, as
identified by the Committee.
4.
Risk assessment — The evaluation of the likelihood of
entry, establishment or spread of a pest or disease within the
territory of an importing Member according to the sanitary or
phytosanitary measures which might be applied, and of the associated
potential biological and economic consequences; or the evaluation of
the potential for adverse effects on human or animal health arising
from the presence of additives, contaminants, toxins or
disease-causing organisms in food, beverages or feedstuffs.
5.
Appropriate level of sanitary or phytosanitary protection
— The level of protection deemed appropriate by the Member
establishing a sanitary or phytosanitary measure to protect human,
animal or plant life or health within its territory.
NOTE:
Many Members otherwise refer to this concept as the “acceptable
level of risk”.
6.
Pest- or disease-free area — An area, whether all of a
country, part of a country, or all or parts of several countries, as
identified by the competent authorities, in which a specific pest or
disease does not occur.
NOTE:
A pest- or disease-free area may surround, be surrounded by, or be
adjacent to an area — whether within part of a country or in a
geographic region which includes parts of or all of several countries
—in which a specific pest or disease is known to occur but is subject
to regional control measures such as the establishment of protection,
surveillance and buffer zones which will confine or eradicate the pest
or disease in question.
7.
Area of low pest or disease prevalence — An area,
whether all of a country, part of a country, or all or parts of
several countries, as identified by the competent authorities, in
which a specific pest or disease occurs at low levels and which is
subject to effective surveillance, control or eradication measures.
Annex
B: Transparency Of Sanitary And Phytosanitary
Regulations back to top
Publication
of regulations
1.
Members shall ensure that all sanitary and phytosanitary regulations(5)
which have been adopted are published promptly in such a manner as to
enable interested Members to become acquainted with them.
2.
Except in urgent circumstances, Members shall allow a reasonable
interval between the publication of a sanitary or phytosanitary
regulation and its entry into force in order to allow time for
producers in exporting Members, and particularly in developing country
Members, to adapt their products and methods of production to the
requirements of the importing Member.
Enquiry points
3.
Each Member shall ensure that one enquiry point exists which is
responsible for the provision of answers to all reasonable questions
from interested Members as well as for the provision of relevant
documents regarding:
(a)
any sanitary or phytosanitary regulations adopted or proposed within
its territory;
(b)
any control and inspection procedures, production and quarantine
treatment, pesticide tolerance and food additive approval procedures,
which are operated within its territory;
(c)
risk assessment procedures, factors taken into consideration, as well
as the determination of the appropriate level of sanitary or
phytosanitary protection;
(d)
the membership and participation of the Member, or of relevant bodies
within its territory, in international and regional sanitary and
phytosanitary organizations and systems, as well as in bilateral and
multilateral agreements and arrangements within the scope of this
Agreement, and the texts of such agreements and arrangements.
4.
Members shall ensure that where copies of documents are requested by
interested Members, they are supplied at the same price (if any),
apart from the cost of delivery, as to the nationals(6)
of the Member concerned.
Notification
procedures
5.
Whenever an international standard, guideline or recommendation does
not exist or the content of a proposed sanitary or phytosanitary
regulation is not substantially the same as the content of an
international standard, guideline or recommendation, and if the
regulation may have a significant effect on trade of other Members,
Members shall:
(a)
publish a notice at an early stage in such a manner as to enable
interested Members to become acquainted with the proposal to introduce
a particular regulation;
(b)
notify other Members, through the Secretariat, of the products to be
covered by the regulation together with a brief indication of the
objective and rationale of the proposed regulation. Such
notifications shall take place at an early stage, when amendments can
still be introduced and comments taken into account;
(c)
provide upon request to other Members copies of the proposed
regulation and, whenever possible, identify the parts which in
substance deviate from international standards, guidelines or
recommendations;
(d)
without discrimination, allow reasonable time for other Members to
make comments in writing, discuss these comments upon request, and
take the comments and the results of the discussions into account.
6.
However, where urgent problems of health protection arise or threaten
to arise for a Member, that Member may omit such of the steps
enumerated in paragraph 5 of this Annex as it finds necessary,
provided that the Member:
(a)
immediately notifies other Members, through the Secretariat, of the
particular regulation and the products covered, with a brief
indication of the objective and the rationale of the regulation,
including the nature of the urgent problem(s);
(b)
provides, upon request, copies of the regulation to other Members;
(c)
allows other Members to make comments in writing, discusses these
comments upon request, and takes the comments and the results of the
discussions into account.
7.
Notifications to the Secretariat shall be in English, French or
Spanish.
8.
Developed country Members shall, if requested by other Members,
provide copies of the documents or, in case of voluminous documents,
summaries of the documents covered by a specific notification in
English, French or Spanish.
9.
The Secretariat shall promptly circulate copies of the notification to
all Members and interested international organizations and draw the
attention of developing country Members to any notifications
relating to products of particular interest to them.
10.
Members shall designate a single central government authority as
responsible for the implementation, on the national level, of the
provisions concerning notification procedures according to paragraphs
5, 6, 7 and 8 of this Annex.
General
reservations
11.
Nothing in this Agreement shall be construed as requiring:
(a)
the provision of particulars or copies of drafts or the publication of
texts other than in the language of the Member except as stated in
paragraph 8 of this Annex; or
(b)
Members to disclose confidential information which would impede
enforcement of sanitary or phytosanitary legislation or which would
prejudice the legitimate commercial interests of particular
enterprises.
Annex C: Control,
Inspection And Approval Procedures (7)
back to top
1.
Members shall ensure, with respect to any procedure to check and
ensure the fulfilment of sanitary or phytosanitary measures, that:
(a)
such procedures are undertaken and completed without undue delay and
in no less favourable manner for imported products than for like
domestic products;
(b)
the standard processing period of each procedure is published or that
the anticipated processing period is communicated to the applicant
upon request; when receiving an application, the competent body
promptly examines the completeness of the documentation and informs
the applicant in a precise and complete manner of all deficiencies;
the competent body transmits as soon as possible the results of the
procedure in a precise and complete manner to the applicant so that
corrective action may be taken if necessary; even when the
application has deficiencies, the competent body proceeds as far as
practicable with the procedure if the applicant so requests; and
that upon request, the applicant is informed of the stage of the
procedure, with any delay being explained;
(c)
information requirements are limited to what is necessary for
appropriate control, inspection and approval procedures,
including for approval of the use of additives or for the
establishment of tolerances for contaminants in food, beverages or
feedstuffs;
(d)
the confidentiality of information about imported products arising
from or supplied in connection with control, inspection and approval
is respected in a way no less favourable than for domestic products
and in such a manner that legitimate commercial interests are
protected;
(e)
any requirements for control, inspection and approval of individual
specimens of a product are limited to what is reasonable and
necessary;
(f)
any fees imposed for the procedures on imported products are equitable
in relation to any fees charged on like domestic products or products
originating in any other Member and should be no higher than the
actual cost of the service;
(g)
the same criteria should be used in the siting of facilities used in
the procedures and the selection of samples of imported products as
for domestic products so as to minimize the inconvenience to
applicants, importers, exporters or their agents;
(h)
whenever specifications of a product are changed subsequent to its
control and inspection in light of the applicable regulations, the
procedure for the modified product is limited to what is necessary to
determine whether adequate confidence exists that the product still
meets the regulations concerned; and
(i)
a procedure exists to review complaints concerning the operation of
such procedures and to take corrective action when a complaint is
justified.
Where
an importing Member operates a system for the approval of the use of
food additives or for the establishment of tolerances for contaminants
in food, beverages or feedstuffs which prohibits or restricts access
to its domestic markets for products based on the absence of an
approval, the importing Member shall consider the use of a relevant
international standard as the basis for access until a final
determination is made.
2.
Where a sanitary or phytosanitary measure specifies control at the
level of production, the Member in whose territory the production
takes place shall provide the necessary assistance to facilitate such
control and the work of the controlling authorities.
3.
Nothing in this Agreement shall prevent Members from carrying out
reasonable inspection within their own territories.
<
Previous
|
