The Russia-Kazakhstan-Belarus Customs Union (CU) published the following draft document regarding inspection guidelines for determination of SPS equivalence
THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY
USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT
GAIN Report Number: RS1274
Customs Union Publishes Inspection Guidelines for Public
FAIRS Subject Report
Trade Policy Monitoring
Livestock and Products
Poultry and Products
Dairy and Products
The Russia-Kazakhstan-Belarus Customs Union (CU) published draft inspection guidelines for
determination of SPS equivalence on its website. These guidelines cover the inspection of products and
establishments subject to CU veterinary control. There is a 60-day public comment period, starting
November 16, 2012, and ending January 15, 2013. Interested U.S. parties are encouraged to share their
comments and concerns with USDA’s enquiry point (IRSD@fas.usda.gov).
The Russia-Kazakhstan-Belarus Customs Union (CU) published the following draft document regarding
inspection guidelines for determination of SPS equivalence on its website: Guidelines for Inspectors for
Confirming Equivalence of Applied Veterinary Measures during Inspections of Objects that are Subject
to Veterinary Control in Third Countries.
Unofficial English translation of the above draft document can be found below. There is a 60-day public
comment period, starting November 16, 2012, and ending January 15, 2013. Interested U.S. parties are
encouraged to share their comments and concerns with USDA’s enquiry point (IRSD@fas.usda.gov).
USDA, in turn, will share collected comments/concerns with the Eurasian Economic Commission.
As of the date of publication of this report, FAS/Moscow does not believe this measure has been notified
to the World Trade Organization.
BEGIN UNOFFICIAL TRANSLATION:
Annex to Decision
of Collegium of Eurasian Economic
Guidelines for Inspectors for Confirming Equivalence of Applied Veterinary Measures during
Inspections of Objects that are Subject to Veterinary Control in Third Countries.
These guidelines are designed taking into account:
1. The fact that some importing and exporting countries have different systems for inspection of
objects controlled by veterinary supervision. These differences are due to differences in the prevalence
of certain risks selected by the country risk management activities, and the differences in the historical
development of systems of veterinary supervision.
2. In such circumstances, in order to facilitate trade and thus to protect animal and human health,
the exporting and importing country can organize a joint analysis of the efficiency of veterinary and
sanitary measures of the exporting country in achieving the appropriate level of veterinary and sanitary
protection in the importing country consistent with the principle of equivalence under the Agreement on
the Application of Sanitary and Phytosanitary Measures of the World Trade Organization (WTO SPS
3. Application of the principle of equivalence is mutually beneficial for both the importing
country and the exporting country. Protecting animal and human health, it facilitates trade and reduces
the costs of regulation to governments, industry, producers and consumers, enabling the exporting
In accordance with the definition of "equivalence" in Section 3, the equivalent measures (i.e. measures that are different
from those used by the importing country, but, nevertheless, ensuring appropriate level of protection of the importing
country) must be different from measures that coincide with those in the importing country.
country to use the most effective means in the circumstances in order to achieve an adequate level of
protection of the importing country 3.
4. Importing countries must avoid application of unnecessary measures if they are already carried
out by the exporting country. Importing countries should be able to reduce the frequency and volume of
confirming measures following the decision on the equivalence of measures applied in the exporting
5. Normative legal acts of the Customs Union:
- Agreement on the Customs Union on veterinary and sanitary measures of 11 December 2009;
- Decision of the Customs Union Commission of June 18, 2010 No. 317 "On the application of
veterinary and sanitary measures in the Customs Union" (as amended by the decision of the Commission
of the Customs Union No. 342 of August 17, 2010, No. 455 of November 18, 2010, No. 623 of April 7,
2011, No. 724 of June 22, 2011);
- Decision of the Customs Union Commission No. 625 of April 7, 2011 "On ensuring the
harmonization of legislation of the Customs Union on the application of sanitary, veterinary and
phytosanitary measures with international standards";
- Decision of the Customs Union Commission No. 721 of June 22, 2011 "On the application of
international standards, recommendations and guidelines";
- Decision of the Customs Union Commission No. 801 of September 23, 2011 “On the
Regulation on the common procedure of the examination of legal acts of the Customs Union on the
application of sanitary, veterinary and phytosanitary measures”;
- Decision of the Customs Union Commission No. 834 of October 18, 2011 "On the Regulation
of a single system of joint inspections of sites and sampling of goods (products) subject to veterinary
- Decision of the Customs Union Commission No. 835 of October 18, 2011 "On the equivalence
of sanitary, veterinary and phytosanitary measures, and risk assessment."
6. The need to consider when inspecting the controlled the Codex Alimentarius guidelines, such
as the CAC / RCP 1-1969 (recommended international general principles of food hygiene), CAC / RCP
58 - 2005 (code of hygienic practice for meat), CAC / RCP 57-2004 (Code Hygienic Practice for Milk
and milk products), CAC / RCP 52-2003 (Code of practice for fish and fishery products) and other
relevant international standards, guidelines and related documents.
II. Sphere of application
7. Definitions present in the document correspond to the Codex Alimentarius and the WTO SPS
Veterinary and sanitary measure: any measure applied to protect animal and human health in
the country from risks arising from the entry, establishment or spread of diseases, pests - vectors of
diseases, or disease-causing organisms, additives, and the presence of contaminants, toxins or disease-
causing organisms in controlled goods, as well as due to the risks arising from diseases transmitted with
the controlled goods, or because of the risks associated with other hazards in controlled goods.
Note: Veterinary and sanitary measures include all relevant laws, decrees, regulations,
requirements and procedures including, inter alia, the relevant requirements relating to controlled goods,
Benefits to the exporting country on the application of the principle of equivalence can be rejected if the request for
equivalence is used as an excuse for breaking the existing trade. Such action of the importing country would be contrary to
the principles of international trade.
methods of production and processing, testing procedures, inspection, certification and granting of
permits, sampling procedures and risk assessment, as well as the requirements for packaging and
labeling, directly related to food safety.
Hazard: Biological, chemical or physical agents in the controlled products that have the potential
to cause adverse effects on health.4
Risk: The probability of adverse effects on health and the severity of the impact, which follows
logically from the dangerous controlled goods.
Risk assessment: assessment of the likelihood of entry, establishment, or spread of a pest or
disease within the territory of the importing country with respect to sanitary or phytosanitary measures
which might be applied, and the associated potential biological and economic consequences; or
assessment of the possible adverse effects on human or animal health, arising from the presence of
additives, contaminants, toxins or disease-causing organisms in controlled goods.
Scientifically-based process consisting of the following steps: 1) hazard identification, 2) hazard
characterization and 3) exposure assessment, and 4) risk characterization.4
The appropriate level of veterinary and sanitary protection (ALOP): The level of protection
that is deemed appropriate for the protection of human life and health in the country establishing
veterinary and sanitary measures. (In other words, this concept can be defined as an "acceptable level of
Equivalence of veterinary and sanitary measu 5res: Equivalence - a condition in which the
veterinary and sanitary measures applied in the exporting country, although different from those used in
the importing country, achieve the level of veterinary and sanitary protection, corresponding to the level
of the importing country, as demonstrated by the exporting country.
III. General principles for determination of equivalence
8. Determination of equivalence of veterinary and sanitary measures relating to inspection of the
controlled objects is based on the application of the following principles:
a) The importing country has the right to determine the level of veterinary and sanitary
protection, which it considers necessary for the protection of animal and human health.6 ALOP may be
expressed in qualitative and quantitative terms.
b) Veterinary and sanitary measure7 used in the importing country, shall actually achieve the
ALOP of the importing country and should be applied in accordance with article 2.3 of the WTO SPS
Commission "Codex Alimentarius": Procedures Manual (Version 12), pages 43-44.
Equivalence is defined in CAC / GL 26-1997 as "the ability of different systems of inspection and certification meet the
Agreement on SPS measures defines the rights and obligations of WTO Members in respect of determining the appropriate
level of sanitary protection.
A reference to "measure" in this section in the singular can also mean a reference to "measures" or "a package of measures",
depending on the circumstances.
Equivalent measures can achieve the ALOP of the importing country, or in combination with other measures, they can
contribute to achieving the ALOP of the importing country. In the remainder of this guide, any reference to the latter should
be regarded as including the feature.
c) The importing country must describe how its veterinary and sanitary measure achieves the
d) The importing country must recognize that the veterinary and sanitary measures other than its
own, can achieve the ALOP of the importing country.
e) Veterinary and sanitary measure, proposed by the exporting country as equivalent must
achieve the ALOP of the importing country.
f) At the request of the exporting country the importing country within a reasonable time should
rapidly begin consultations to determine the equivalence of certain veterinary and sanitary measure 9s .
g) The exporting country should objectively demonstrate that its veterinary and sanitary measure
can achieve the ALOP of the importing country.
h) A comparison of veterinary and sanitary measures of the countries should be done in an
i) If during the demonstration of equivalence a risk assessment is used, countries should make
every effort to achieve consistency in the methods used, using, where appropriate, the internationally
accepted methodology and taking into account the relevant texts of the "Codex Alimentarius"
Commission (hereinafter - the Codex).
j) The importing country must take into account the knowledge and experience gained by the
inspection of controlled objects in the exporting country in order to carry out the determination in a
more effective way and faster.
k) The exporting country should provide access to the inspection and certification systems,
which are the subject of the equivalence determination, for their review and evaluation at the request of
the importing country bodies supervising the control goods.
l) All equivalence assessments should take into account the means, by which equivalence is
m) Countries should ensure transparency both in the demonstration, and the evaluation of
equivalence, providing consultations to all interested parties, in cases where this is feasible. Exporting
and importing countries should consider the procedure for evaluating the equivalence in coordination
with each other.
n) The importing country should consider favorably the request of a developing country
exporting country to provide appropriate technical assistance that will contribute to a better
determination of equivalence.
IV. Conditions for determination of equivalence
9. The determination of equivalence may be required for any veterinary and sanitary measure or
series of measures relating to controlled goods. Appropriate veterinary and sanitary measures, which
form a system of veterinary control in the exporting country, which are not the object of equivalence
determination, must meet the requirements of the importing country.
10. The scope of determination of equivalence should depend on previous experience,
knowledge, and confidence that the importing country takes into account the measures of veterinary
control of the exporting country.
11. When the importing country has accumulated experience, knowledge, and confidence in the
veterinary control measures, in respect of which equivalence is evaluated, and the countries agree that
Guidelines for the development, implementation, evaluation, and accreditation of the systems of inspection and certification
of imports and exports of food, CAC / GL 26 - 1997.
the import requirements are fully met (for example, when there is an experience of trade), determination
of equivalence of veterinary and sanitary measures can be carried out without further consideration of
other relevant measures constituting the system of veterinary control.
12. If the importing country has no accumulated experience, knowledge, or confidence in the
veterinary control measures, whose equivalence is being assessed, and the countries have not established
that the import requirements are fully met (for example, if the proposal on trade in controlled goods is
made for the first time), determination of equivalence of veterinary and sanitary measures would require
further consideration of the relevant measures, which form the basis of the system of veterinary control.
13. In order to determine the equivalence, the veterinary and sanitary measures associated with
the system of inspection can be roughly classified as follows:
a) Infrastructure: including the legal framework (e.g., food legislation and implementing laws)
and administrative systems (e.g., organization of national or regional authorities, the law enforcement
b) a draft program, implementation and monitoring: including documents on systems,
monitoring, implementation, criteria for decision-making and action, laboratory facilities, transport
infrastructure and regulations on certification and audits, and / or
c) specific requirements, including requirements applicable to individual facilities (e.g. premises,
structures), equipment (e.g. models of mechanisms that come into contact with food products), processes
(e.g. HACCP plans), procedures (e.g. pre-and post-mortem inspections), tests (e.g. laboratory tests for
microbiological and chemical hazards), and the methods of sampling and inspection.
14. This categorization is likely to facilitate an agreement between the countries based on a
comparison of veterinary and sanitary measures that are the subject of determination of equivalence (see
Section V). In the future, breaking measures into certain categories can help countries to simplify
determination of equivalence relating to other veterinary and sanitary measures that make up the control
system of controlled goods.
V. Objective basis of comparison
15. Since veterinary and sanitary measures applied by importing country are designed to achieve
its ALOP, the exporting country can demonstrate achievement of the ALOP of the importing country by
demonstrating that the measures, which it proposes as equivalent, have the same effect in achieving the
ALOP of the importing country, as the appropriate veterinary and sanitary measures applied by
importing country with the help of an objective basis of comparison.
16. The importing country on request of the exporting country shall specify as precisely as
possible, the objective basis for comparison of the veterinary and sanitary measures, proposed by the
exporting country with its own measure 11s . The dialogue between the exporting country and the
importing country will promote understanding and agreement on the objective basis for comparison.
Additional information provided by the importing country, may include:
The objective basis for comparison of veterinary and sanitary measures that are classified as "Infrastructure" is likely to
have a qualitative nature, for example, ability of legislation to control food and to achieve the main objectives of food
security. Objective basis for comparison of veterinary and sanitary measures that are classified as "Specific requirements" is
likely to have a quantitative nature, for example, comparison of the level of control of hazards, achieved by this measure. The
objective basis for comparison of veterinary and sanitary measures that are classified as "the program" is likely to contain a
mixture of qualitative and quantitative elements, for example, correct application of principles and the corresponding critical
limits in the food control system HACCP.
a) the reason / purpose of veterinary and sanitary measures, including identification of specific
risks, which are addressed by the measure;
b) the interrelationship of the veterinary and sanitary measures and the ALOP, i.e. how the
veterinary and sanitary measure achieves the ALOP;
c) if necessary, the expression of the level of hazard control in controlled goods, achieved by the
veterinary and sanitary measure;
d) scientific basis for the veterinary and sanitary measure under consideration, including risk
assessment, if necessary;
e) any additional information that may assist the exporting country in presenting an objective
demonstration of equivalence.
VI. Procedure for determination of equivalence
17. The importing country should make public the details of its veterinary and sanitary measures
to the exporting country on request. The exporting country should review all applicable veterinary and
sanitary measures of the importing country with respect to the controlled goods in question and identify
those that meet the requirements and those, which require determination of equivalence. Importing and
exporting countries should use agreed processes for the exchange of relevant information to assist in
determining equivalence. This information must be limited to that, which is necessary for this purpose.
18. Determination of equivalence is ensure both by the exporting country and the importing
country, following the successive stages, such as those described below and illustrated in Figure 1. The
Parties must work together on these steps in order to reach agreement:
a) The exporting country indicates the veterinary and sanitary measure of the importing country,
which she would like to replace with another measure, and asks about the reason / ground for application
of that measure.
b) The importing country provides the reason / ground for the application of that measure and
other relevant information in accordance with paragraph 8.
c) In accordance with paragraph 8 the importing country should indicate as accurately as possible
an objective basis for a comparative analysis of veterinary and sanitary measures proposed by the
exporting country and its own. At the initiative of the exporting country, the importing and exporting
countries should enter into a dialogue on the objective basis for the specified comparison in order to
d) The exporting country prepares a package of documents, using a risk assessment or other
relevant methodology (based on feasibility), to demonstrate that with the application of other veterinary
and sanitary measure an appropriate level of veterinary and sanitary protection (ALOP) of the importing
country is achieved, and provides it to the importing country.
e) The importing country analyzes the documents and, if this is enough, uses the specified
documents to determine whether the appropriate level of protection (ALOP) of the importing country is
achieved by the measure of the exporting country.
f) If the importing country has any concerns about the package of documents submitted, it should
in no time notify the exporting country thereof and should elaborate on the reasons for its concerns. If
possible, the importing country should submit proposals for the way, in which these concerns can be
g) The exporting country should respond to these concerns by providing additional information,
changes in its proposals, or taking other action as appropriate.
h) The importing country notifies the exporting country of its view over the relevant time period,
and provides arguments for its decision on the fact that the mentioned sanitary measure is not
equivalent, i.e. when it is used an appropriate level of sanitary protection (ALOP) of the importing
country is not achieved.
i) Efforts should be made to resolve differences of opinion concerning the evaluation of the
submitted documents, both preliminary, and final.
VII. Assessment of equivalence
19. Assessment of equivalence by the importing country should be based on the transparent
analytical process that is objective and consistent, and includes consultations with all interested parties,
to the extent practicable and appropriate.
20. In assessing the equivalence of veterinary and sanitary measures the following should be
taken into account:
a) the experience, expertise and reliability of the systems of inspection and certification of food
products in the exporting country (see Section IV);
b) supporting data provided by the exporting country;
c) analysis of the strength of the relationship between this veterinary and sanitary measure of the
exporting country and the achievement of an appropriate level of veterinary and sanitary protection of
the importing country, as reflected in an objective basis for comparison (see Section V);
d) parameters must be specified in quantitative terms, to the extent possible;
e) the adequacy of the quality characteristics in cases where the level of hazards control in
controlled goods is not quantifiable;
f) Analysis of variability and other sources of uncertainty in the data;
g) analysis of the expected impact on animal and human health as a result of this veterinary and
sanitary measure of the exporting country;
h) Codex texts on the issues of safety of the controlled goods.
After conducting any assessment of equivalence, the exporting and importing countries should
immediately inform each other of important changes in their support programs and infrastructure that
may have an impact on the determination of equivalence.
21. Procedures Manual for carrying out assessments of the exporting country’s systems by the
importing country can be found in the Annex.
Figure I: A simplified scheme for determination of equivalence
Exporting country Importing country
Specify the veterinary and sanitary measure(s) (18.a)
Requirement to specify the reason/purpose of veterinary and
sanitary measure(s) (18.a) Provide the reason/purpose of
veterinary and sanitary measure(s)
Objective basis for comparison? (18.c)
No need for dialogue Dialogue
Provide the rationale
for alternative veterinary and sanitary measure(s) proposed as
(18.d) Assessment (18.e)
Yes List of
Response to the concerns of the importing country: Alternative concerns
veterinary and sanitary measure(s); further development of
justification (18.g) (18.f)
In assessing the systems of state inspection and certification, the following additional principles shall be
Principles to the actions by inspectors and experts of the competent authorities of the importing
and exporting country in the process of assessment
A. Assessments should focus on the result, they should be transparent, constructive, and should be
conducted in an agreed, ethical, and professional manner, as necessary, with respect to confidential
B. The importing and exporting countries should apply an agreed process for reviewing all the issues
that may arise during the process assessment.
C. The importing and exporting countries should agree on the appropriate method of assessment before
its start, based on the agreed scope and purpose.
Principles of the process of assessment
D. The process of assessment should be planned, it should be systematic, transparent, consistent, fully
documented, and communicated.
E. The plan, including the rationale, objectives, scope, requirements and evaluation methods for
assessing the system of state inspection and certification should be clearly defined by the importing
country, communicated to the competent body(ies) of the exporting country and agreed with him within
a reasonable time prior to the start of assessment.
Principle of accounting for assessment
F. Agreed corrective actions, timeframes and subsequent verification procedures should be clearly
established and documented.
G. The final report on assessment should be clear and transparent, it can be published, if necessary,
subject to confidentiality.
Assessments should focus on the result, they should be transparent, constructive, and should be
conducted in an agreed, ethical, and professional manner, as necessary, with respect to
1. Inspectors and experts from the competent authority of the importing country should be able to
demonstrate that the results of the assessment, conclusions and recommendations are focused on
whether there is a likelihood that the desired results will be achieved by the system and that they are
supported by objective data or the data that have been approved as accurate and reliable.
2. During the assessment, all arising issues should be solved by the inspectors and experts of the
competent authorities in an agreed, ethical and professional manner.
3. Inspectors and experts from the competent authorities of the importing country should observe
impartiality. Inspectors and experts should have the appropriate qualifications, experience, and must be
trained both in the relevant field of expertise, and in the field of audit methods.
4. During the assessment the inspectors and experts of the importing country should ensure that
confidential information is protected.
The importing and exporting countries should apply an agreed process for reviewing all the issues
that may arise during the process assessment
5. Prior to the start of assessment, the key elements of the process of addressing issues that may arise
during the assessment should be agreed upon. The competent authorities of the importing and exporting
countries should seek to resolve all issues arising in the assessment together in an open and transparent
manner. If any questions remain unresolved, they should be included in a report on the assessment with
The importing and exporting countries should agree on the appropriate method of assessment
before its start, based on the agreed scope and purpose.
6. The most efficient and effective method should be chosen, that which can evaluate the effectiveness
of the public system for inspection and certification of the exporting country, including the possibility
for the competent body(ies) of the exporting country to organize and implement control, and provide the
necessary guarantees to the importing country.
7. When choosing a method of assessment, it is important to consider the reason for the assessment. For
example, assessments may be part of a risk analysis conducted before trade is launched, they can assess
a system of state inspection and certification or control of a single element (e.g., chemical residues) or
special exporting establishments.
8. When choosing a method of assessment, the experience, knowledge and reliability1 of the importing
country regarding the system of state inspection and certification of the exporting country should be
taken into account.
Paragraph 9-14 of Appendix to the Guidelines for assessing the equivalence of sanitary measures associated with the
system of inspection and certification of food products (CAC / GL 53-2003) provide additional guidance as to what is the
experience, expertise and reliability, as well as expanding the information out in paragraph 10.12 of this manual.
9. The method of the audit, which is often called a "system audit," should focus on the assessment
whether the system of state inspection and certification, or its components, of the exporting country
serves its purpose.
10. In contrast to the study of all the procedures, system audits are based on the study of an example
system procedures, documents or records and, if required, a number of sites within the scope of the
system being audited.
11. The system approach focuses on the system(s) of control and according to it, all items identified as
compliant/incompliant should be considered in the context of the whole system.
12. A system audit may include the study of the elements (legal framework, means of control,
procedures, facilities, equipment, laboratories, vehicles, communications equipment, personnel and
training to achieve the objectives of the inspection and certification prorgram), or, if necessary, other
Method of inspection
13. In some cases, a method of inspection may be used to confirm the efficiency of control inspections
conducted by a competent body(ies) in the exporting country.
14. Inspections may include the study of the following:
(a) How the company meets the requirements, including consideration of specific activities and
product specifications, supervision and review of the company’s activities and the relevant
records of activities;
(b) The number of employees in the company, if it is specified in the request;
(c) What inspectors are allowed to do, if it is particularly pointed out in the requirements.
The process of assessment should be planned, it should be systematic, transparent, consistent, fully
documented, and communicated.
15. Documents confirming the findings, conclusions and recommendations should be executed so that
the efficiency of the assessment and presentation of its results were uniform, transparent, and reliable.
16. The competent authorities of the importing and exporting countries should be consulting each other
in preparation for and during the assessment on all points of the process, from development of a plan for
the assessment to the final report and decisions on all issues that arise during the assessment. To ensure
regular and transparent communication, the competent authorities of the importing and exporting
countries should designate contact persons or points of contact for the assessment.
The plan, including the rationale, objectives, scope, requirements and evaluation methods for
assessing the system of state inspection and certification should be clearly defined by the
importing country, communicated to the competent body(ies) of the exporting country and agreed
with him within a reasonable time prior to the start of assessment.
17. In determining the rationale, objectives, scope, frequency, and methods of assessment the competent
authority of the importing country should take into account the established level of experience,
knowledge, and reliability, along with a history of previous assessments for the period since the last
assessment, and any other relevant factors.
18. The procedure of systematic evaluation for the assessment should be based on the pre-defined and
structured program in accordance with the purpose of assessment.
19. The following information should be exchanged at the time of initial request and before the start of
assessment of an existing system of state inspection and certification:
a) Rationale for or the need for assessment may occur for several reasons, including the legal
obligations of the importing country or the need to understand the respective roles of the
competent authorities of the importing country and the exporting country or the need to ensure
the ability of the exporting country’s system or facilities for food production/processing to
ensure compliance with the requirements.
b) The purpose of assessment may, for example, be as follows: to confirm the effective application /
implementation of special measures or technical requirements of the system of inspection and
certification of the exporting country; to confirm compliance by the exporting country with the
measures of the importing country; to assess compliance of equivalence agreements or other
types of mutual acceptance of the systems, investigate outbreaks of diseases transmitted through
food and related to imported / exported food products and monitor corrective actions arising
from the previous assessments or situations that have arisen in connection with the problems in
the area of food safety. If necessary, an audit of a risk assessment component of the food safety
control system of the exporting country to support risk management practices may be conducted.
c) It is necessary to define the scope of assessment, that is: whether the assessment covers the entire
system, or only some of its components, measures, technical requirements, or products.
d) It is necessary to define the intended method of assessment, including requirements, which will
be covered by the assessment of the state system of inspection and certification of the exporting
20. In all cases, the competent authority of the importing country shall inform the competent authority of
the exporting country of the proposed assessment so that the competent authority could organize the
necessary activities, such as logistics and information gathering. If the rationale for the assessment is an
important public health problem, the notice shall reflect the urgency associated with the risk to human
Preparation for assessment
21. It is necessary to prepare a plan for carrying out the assessment, including methods of assessment,
timing, and exchange of necessary information, and submit it to the competent authority of the exporting
country within a reasonable period of time. The plan should include the following:
a) Objectives and scope of assessment, including whether it is a separate assessment or if it is
related to another assessment (for example, control of the previous assessment) or a series of
b) Areas / elements for review / analysis, which may include the records and evaluation of
c) The expected period for carrying out the assessment and drawing the report;
d) The criteria for assessment of the public system for inspection and certification of the exporting
e) Contact person for the members of the assessment team, who can negotiate the details of the
assessment plan, and - if necessary - the members of the assessment team, including foreign
auditors / inspectors, chief auditor / inspector, technical experts and interpreters;
f) The language that will be used during the assessment, including translation, availability of the
competent and impartial interpretation and resources.
g) Specification of the type, and if possible / necessary the places of visits (e.g., offices,
laboratories, or other facilities), and the timing and responsibility for the notification about the
places if necessary (although this can be done at the opening meeting prior to the assessment);
h) Date of assessment, dates of the opening and final meetings and the expected date for
communicating the comments on the assessment;
i) route and other logistics necessary for the assessment visit, and
j) Methods of protection of confidential information.
22. Since it is necessary to ensure compliance with the assessment plan, it should be flexible so that it
would be possible to make changes based on the information collected prior to or at the time of the
assessment. Proposed significant changes to the assessment plan should be made only under mitigating
circumstances, and they should be reported as soon as possible to the appropriate authority.
23. It is necessary to agree beforehand on the language to be used during the assessment, including
translation, availability of the competent and impartial interpretation and resources.
24. To the extent possible, documentary information required for the planning, conducting and
completion of the assessment is to be sought and provided prior to assessment using means of electronic
communication as possible.
a) A request for the preparation of an assessment should specify the scioe of assessment and its
b) If this is a verification assessment, then the exporting country will only need to provide
information that has changed since the previous assessment, or has not been requested in the
c) If the purpose of a request for information is not clear to the exporting country, and there are
several problems associated with the requested information, the exporting country may require
that the importing country provide explanations of the purpose and use of such information.
d) If a visit to a facility is proposed as a method for assessment, prior to the visit, it is necessary to
analyze the documents that describe the system, including legislative support.
25. In some cases, the assessment can be suspended or terminated prior to a facility visit, depending on
the nature of the information provided by the competent authority of the exporting country, and in this
case the competent authority of the importing country should clearly inform the competent authority of
the exporting country of the cause. The competent authority of the exporting country should have the
opportunity to receive explanations on the information provided, if deemed necessary.
Starting / Opening Assessment Meeting
26. If the assessment includes a visit, it is necessary to hold a starting or introductory meeting.
a) The meeting shall be held at a place designated by the competent authority of the exporting
b) The meeting should address all aspects of the assessment plan, including final adjustments; the
purpose of the meeting - to review the system of state inspection and certification in the country
and to confirm the parameters and logistics of the assessment.
c) It is necessary to agree on ways to ensure continuous interaction and communication between the
parties during the assessment.
Closing / Summary Meeting
27. If the assessment includes a visit, it is necessary to hold a closing or summary meeting.
a) The meeting shall be held at a place designated by the competent authority of the exporting
b) The evaluation team should summarize and present the main findings and preliminary
conclusions. It is necessary to specify any inconsistencies and bring objective evidence to
support the conclusions. Correction of inconsistencies should be the responsibility of the
competent authority of the exporting country and verified by the competent authority of the
importing country, including the verification assessment if necessary.
c) At the meeting the competent authority of the exporting country shall be given the opportunity to
ask questions and get clarification on the results and the comments made at the meeting.
Agreed corrective actions, timeframes, and verification procedures should be clearly established
The final report on assessment should be clear and transparent, and it can be published subject to
confidentiality of information, where applicable.
28. The side, which was assessed, should be given the opportunity to review a draft report during an
agreed period of time, to submit comments and to correct factual errors prior to compiling the final
version of the report. The final report shall include or be accompanied by comments of the competent
authority of the exporting country.
29. The assessment report should present a balanced picture of results, and include conclusions and
recommendations that accurately reflect the results. The report should:
a) contain the purpose, scope, and results;
b) contain the criteria and the process of assessment;
c) include assessment results with supporting evidence for each conclusion along with the
importance, which was discussed at the final meeting;
d) be accessible by prior agreement with the competent authority of the exporting country,
including comments from the competent authority of the exporting country in order to improve
the accuracy of the report;
e) consider the time frame for finalizing the report and for response measures, as agreed between
the competent authorities of the importing country and the exporting country;
f) include a description of how corrective actions will be communicated and agreed upon, including
the way for carrying out a verification assessment;
g) if necessary, include a checklist of elements to be assessed, to support the findings;
h) include the list of results of the assessment;
i) include the key issues and problems that arose during the assessment if there is no agreement on
the findings and corrective actions;
j) include uncertainties and / or any obstacles that have arisen and may have affected the reliability
of the conclusion of the assessment, and
k) contain description of the areas not covered in the assessment report, although falling within the
scope, and the reasons for the deviation from the agreed scope.
30. It is necessary to clearly indicate the timing and the protocol of the verification assessment.
Confirmation of corrective actions may include:
a) guarantees provided by the competent authority of the exporting country;
b) documents submitted by the competent authority of the exporting country, or
c) the declared corrective actions in the subsequent assessment.
31. In compiling and subsequent distribution of the assessment report, confidential information should
32. After drawing up the final report the competent authorities of the importing and exporting country
should discuss and possibly agree on whether the report will be published and how it should be done in
view of the confidentiality of information, if any.
END UNOFFICIAL TRANSLATION.