International Guidelines and Equivalence Recognitionmddb.apec.org/Documents/2018/SCSC/WKSP4/18_scsc_wksp4_002.… · One of the latest International Drivers Principles and Guidelines

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2018/SCSC/WKSP4/002 Session: 1

International Guidelines and Equivalence Recognition

Submitted by: New Zealand

Workshop on Trade Facilitation Through the Recognition of Food Safety Systems

EquivalenceLima, Peru

21-22 June 2018

www.mpi.govt.nz • 1 www.mpi.govt.nz

APEC Workshop on:

Trade Facilitation through the Recognition of Food Safety

Systems Equivalence

Lima Peru June 2018

Dr Bill Jolly

New Zealand Ministry for Primary Industries

www.mpi.govt.nz • 2

International Guidelines and Equivalence

Recognition

• I’ve been asked to provide an overview of

the guidance developed by the Codex

Alimentarius Commission to facilitate the

implementation of Equivalence


Noting the workshop title is:

“Trade Facilitation through the Recognition

of Food Safety Systems Equivalence”


One of the latest International Drivers

Principles and Guidelines for National Food Control Systems (CAC/GL 82-2013) - Equivalence

• “Competent authorities should recognise that food control

systems or their components although designed and structured differently may be capable of meeting the same objective…..

• “The concept of recognition of systems, including equivalence, should be provided for in the national food control system”

.


Also in the major Commodity Codes of

practice

CODE OF HYGIENIC PRACTICE FOR

MEAT CAC/RCP 58-2005

General Principle 12

xii. Competent authorities should recognise the

equivalence of alternative hygiene measures

where appropriate, and promulgate meat

hygiene measures that achieve required

outcomes in terms of safety and suitability and

facilitate fair practices in the trading of meat.


So what is Equivalence – at least according

to current Codex guidance?


First mention of Equivalence

• The principle of equivalence was established in the

very first CCFICS text:

– Principles for Food Import and Export Inspection and

Certification CAC/GL 20-1995

• Equivalence: “Countries should recognise that

different inspection/certification systems may be

capable of meeting the same objective, and are

therefore equivalent. The obligation to demonstrate

equivalence rests with the exporting country.”


Context surrounding the Principle

• The Principle of equivalence was the 12th of 19

Principles. Noting that the preceding principles

first talk about importing country obligations to

ensure their measures are justified such as:

– Fitness for Purpose (achieving the objectives)

– Risk Assessment (appropriate to the circumstance)

– Non-discrimination (avoid discrimination or a

disguised restriction on trade)

– Harmonisation


First formal definition of Equivalence

• Equivalence was first formally defined in the:

– Guidelines for the design, operation, assessment and

accreditation of food import and export inspection and

certification systems (CAC/GL 26-1997)

• “Equivalence is the capability of different

inspection and certification systems to meet the

same objective.”


CAC/GL 26-1997 : Objectives

“These guidelines provide a framework for the development

of import and export inspection and certification systems

consistent with the Principles for Food Import and Export

Inspection and Certification (CAC/GL 20-1995).

They are intended to assist countries in the application

of requirements and the determination of equivalency,

thereby protecting consumers and facilitating trade in

foodstuffs.”


CAC/GL 26-1997 : Objectives

“Deals with the recognition of equivalence of

inspection and/or certification systems and not with

standards related to specific food products (e.g. food

hygiene, additives and contaminants, labelling etc.)”

“To help build and maintain the necessary confidence in

the inspection and certification system of an exporting

country and facilitate fair trade”


CAC/GL 26-1997: The Guidelines

• Outline several important principles on the recognition

and determination of equivalence and on the

establishment of equivalence agreements.

• Provide guidance that should be taken into account

when an importing country determines that an

assessment of the exporting country’s inspection and

certification systems is necessary.

• Do not mandate the use of such assessments.


CAC/GL 26-1997: Key Sections / Context

• Section 3: Risk Analysis

• Section 4: Quality Assurance

• Section 5: Equivalence (including equivalence

agreements)

• Section 6: Inspection and Certification System

Infrastructure (including: legislative framework; control

programs and operations; and communication;

decision criteria and action; facilities, equipment,

transportation; laboratories; and personnel)


CAC/GL 26-1997: Key Sections / Context

• Section 7: Certification Systems

• Section 8: Official Accreditation

• Section 9: Assessment and Verification of Inspection

and Certification Systems

• Section 10: Transparency

• ANNEX: (doesn’t mention equivalence)

– Principles and Guidelines for the conduct of Assessments of

Foreign Official Inspection and Certification systems


Noting the workshop title is:


Section 5: Equivalence Section

• Recognises that Inspection and Certification

Systems should be tailored to local risk profiles

in the country [Not a one size fits all!]

• Recognises there are different ways of getting to

the same endpoint

– Provides an example: environmental sampling and

strict application of GAP + limited testing can be

equivalent to extensive end product testing for

agchem residues in raw products



• Domestic and import controls should be designed

to achieve the same level of protection.

• The importing country should avoid unnecessary

repetition of controls where these have been

validly carried out by the exporting country.

• In these cases a level of control equivalent to

domestic controls should have been achieved

prior to import.



• Focuses on System-based assessments

• Recognises that equivalence recognitions can

cross reference 3rd Party / Country Assessments

or agreements already done

• Provides some initial advice on the

Documentation of Equivalence Recognitions


Section 6: Inspection and Certification

System Infrastructure

• Countries should identify the main objectives

[public health and fair practises in the food trade]

to be addressed through the import and export

inspection and certification systems

• Countries should have in place: the legislative

framework; control procedures; facilities,

equipment, laboratories, transportation,

communications; personnel; and training to

support these objectives



Systems

• Should be based on a risk analysis as relevant to

the situation

• Should ensure transparency, impartiality and

freedom from conflict of interest

• Should recognise existing quality controls

• Subject to appropriate system-based verification



Systems

• Product coming out of FICS should be subjected

to minimal physical product re-inspections except

where there is a “for cause” justification

• Sampling and method of analysis / QA disciplines

• Decision criteria and actions proportionate to risk

• Cooperation between Competent Authorities


Not all Inspection Systems are Comparable?


Section 8: Certification Systems

• Certification should be based on an effective

and credible inspection / verification system

• Requirements should be justified based on risk

• Should have Integrity, impartiality, be secure

and credible – based on “personal knowledge”

• Certification should lead to facilitated entry


ANNEX: Principles and Guidelines for the

conduct of an assessment of foreign official

inspection and certification systems

• Assessments only where necessary

• Take account of experience, knowledge and

confidence (including 3rd Party)

• Focus on the system not establishments

• Visits only where necessary


Conduct of Assessment Principles

• Assessments should be outcome-focussed,

transparent, evidence-based and conducted in

cooperative, ethical and professional manner and

should protect confidentiality

• Agreed process prior to start, no surprises

• Should result in a summary report which needs to

be consulted on


Assessments and Audits

• The costs incurred in undertaking an

assessment, including travel, normally borne by

the Importing Country.

• Audits, when undertaken, should focus on

assessing whether the official inspection and

certification system is capable of meeting its

objectives


System Audits

• Should focus on just a sample of system

procedures, documents or records and,

where required, just a selection of sites.

• Use of a establishment inspection tool is

only justified where it is not possible to

attain confidence in the wider official

inspection and certification system


Assessment Process

• Pre-Agreed between the countries

• Objective focussed, balanced and timely

• Should look at how the “system” deals with

issues that inevitably arise in any industry

• Should be interactive and consultative

throughout the process


Equivalence Guidance that further expands

on CAC/GL 26-1997

http://www.crossmark.co.nz/Crossmark/field-sales


Guidelines for the Development of Equivalence

Agreements regarding Food Import and Export

Inspection & Certification Systems: CAC/GL 34-1999

• Expands upon CAC/GL 26-1997

• Guidance for governments wanting to enter into

agreements / arrangements or other form of

documented understanding

• Notes they can: enhance the level of confidence &

cooperation; eliminate unnecessary duplication;

provide greater efficiencies; while better

facilitating trade


Scope of the Guidance

• Broad scope potentially covering the full mandate

of Codex: Protection of the health of consumers

and ensuring fair practices in the food trade

• Agreements can cover the entire Food Inspection

and Certification System or be limited to specific

areas of trade or specific products

• Focuses primarily on development of agreements

but delves a little bit into the assessment process


Possible considerations before entering into

discussions

• Are any pre-requisite considerations met

• Is there or is there likely to be sufficient trade to

justify the resources (priority)

• Is some other assessment / recognition

mechanism other than an equivalence

agreement more appropriate


Initiating Discussions

• Type of agreement proposed, the desired effect

on / change to the current trading conditions,

and what sort of legal underpinnings required

• Scope of the Food Inspection and Certification

System (FIC) or products to be covered

• The relevant Competent Authorities in both

countries as relevant to the scope


Consultative Process

• The development of Equivalence Agreements is

facilitated by the use of Codex Standards,

recommendations and guidelines by both parties

• Both countries should agree the scope and discuss

how existing experience, knowledge and confidence

is to be used to simplify the amount of information

that may need to be exchanged and the decisions



• Both countries should discuss and agree on the

process (including any possible in country

verification visit), timelines, and decision criteria

• Importing Country provides the objectives of

relevant parts of its FICS and describes (with

appropriate evidence) how its own system achieves

these



• Exporting country demonstrates with appropriate

evidence how its FICS achieves the same

objectives as achieved by the Importing Country’s

FICS

• Iterative additional discussions take place to assist

clarity of understanding throughout the process

and the draft final decision document and

associated rationale is consulted with the

exporting country


Contents of Equivalence Agreements

• The scope and effect of the equivalence

recognition and who its between

• Notification expectations, issue and problem

resolution procedures to be followed

• Ongoing maintenance and review of

understandings [ including possible suspension

or termination]


Guidelines on the judgement of equivalence of

Sanitary Measures associated with food inspection

and certification systems: CAC/GL 53-2003

• Notes that it is natural for there to be differences in the

Food Inspection and Certification Systems (FICS)

operating in different countries

• Only deals with Sanitary Measures and tends to focus on

a detailed evaluation of specific measures rather than

the system as a whole

• Notes that the application of the principle of equivalence

has mutual benefits for both importing and exporting

countries


Guidelines o the Judgement of Equivalence

of Sanitary Measures

• Extension of and provides more detailed

guidance of certain parts of CAC/GL 26-1997

and CAC/GL 34-1999 but has a narrower scope

• Notes that the intensity of the determination

process will be will depend on the prior

experience, knowledge and confidence that the

importing country has in the food control

measures of the exporting country: Further

develops this concept


General Principles (14):

• Different measures can be capable of achieving

comparable levels of protection relative to the

protection of human health

• Importing countries need to be able to describe

how and what level of protection its sanitary

measures achieve

[Consistent with Article 2.3 of the SPS Agreement]


General Principles

• Entering into consultations on request with the

aim of considering the equivalence of specified

sanitary measures is a WTO/SPS Obligation.

• Should focus on whether the legitimate

objectives of the measure(s) are achieved in the

overall context, and not just focus on comparing

different procedures

• Should be done in a timely, consultative and

cooperative manner


General Principles

• Should take into account any knowledge and

past experience of the exporting country’s Food

Inspection and Certification System (FICS)

• The exporting country needs to provide the

supporting evidence as to how its specified

sanitary measures (within the context which

exists in its country) achieve the level of

protection achieved by the importing country’s

own FICS

General Principles Should be done in a timely, consultative cooperative manner


Things that help the process

• Countries basing their sanitary measures on

Codex standards and related texts

• Prior experience, knowledge and confidence of

the food control measures [in whole or in part] of

the exporting country


Experience, knowledge and confidence

• As a result of trading history (e.g. inspection and

or audit results)

• Knowledge of / confidence in how the exporting

country applies science and risk analysis

principles to the design and operation of its FICS

• Extrapolated from recognitions by and or

agreements with other countries


Objective Basis for Comparison (OBC)

• May be qualitative or quantitative

– Noting it is usually just a proxy and how and

how much an OBC may contribute to the

ALOP will usually be unknown

• May have multiple elements

• Should be consulted and agreed between the

two parties


Objective Basis for Comparison

• “Since the sanitary measures applied by an importing

country have the purpose of achieving its ALOP, an

exporting country may demonstrate achievement of the

importing country’s ALOP by demonstrating that the

measures it proposes have the same effect , relative to

achievement of the importing country’s ALOP, as the

corresponding sanitary measures applied by the

importing country by using an objective basis for

comparison” ???



Supporting information to be provided by the importing

country may include:

• The reason/ purpose for the sanitary measure, including

identifying the specific risks the measure is intended to

address

• The relationship of the sanitary measure to the ALOP i.e.

how the sanitary measure achieves the ALOP



• Where appropriate an expression of the level of control

of the hazard in a food that is achieved by the sanitary

measure

• The scientific basis for the sanitary measure under

consideration including the risk assessment where

appropriate

• Any additional information that may assist the exporting

country in presenting an objective demonstration of

equivalence


Procedure for the determination of equivalence

• The importing country should make available

details of its [as relevant to those its is expecting

to be applied transboundary] sanitary measures

on request

• The exporting country should review all

applicable sanitary measures of the importing

country for the food involved and identify those it

will meet and those for which it is seeks a

determination of equivalence


Information contained within the Submission

• Should not replicate where there is already

existing experience, knowledge and confidence

or previous submissions

• Confined to essential information related to the

defined objective for the determination of

recognition of equivalence

• Useful if the information is supplied in a similar

form to Codex guidance.


Judgement of Equivalence

• Paragraph 32 notes:

– “A favourable decision regarding the judgement of

equivalence, based on the assessment of available

information and taking into account experience,

knowledge and confidence, can be made at any point

in the process:

• At initial contact by the exporting country

• Following a review of the submission

• Following an assessment based on an OBC

• Following an assessment of information from an onsite visit

• Following the resolution of outstanding issues


Judgement of Equivalence

• Should focus on the defined scope as agreed

and should be a cooperative and consultative

process

• Should be as timely and transparent as practical

• Should result in a concluding report, including

the reasoning, should the whole or parts not be

judged to be equivalent


Use of On-site Visits

• May not be necessary but when used may

complement the documentary review

• Where utilised there should be an agreed

protocol prior to any visit

• May provide helpful context to clarify

understandings associated with information

already submitted or to gather more information


CAC/GL 53-2003- Process Flow Diagram


Summary of Existing Guidance

• The original guidance on equivalence in

CAC/GL 26-1997 and CAC/GL 34-1999 is still

good for the most part

• This is high level guidance and covers the full

mandate of codex (SPS and TBT) and focuses

on equivalence of different systems

• It also focuses comparisons on whether the

objective(s) of the system are met



• However both CAC/GL 26-1997 and CAC/GL

34-1999 provide limited detailed guidance on the

process that will help importing and export

countries actually undertake equivalence

assessments and come to decisions

• Work was started around 1999 to supplement

this and the CAC asked this work cover the full

mandate of Codex (SPS and TBT)



• Unfortunately the work on Judgement of

equivalence of sanitary measures initially

focussed on detailed judgements of individual

specified sanitary measures

• CCFICS was not able to come up with a parallel

methodology that shared the same construct for

the determining the equivalence of TBT

measures



• CCFICS work on more detailed parallel SPS/TBT

guidance on both the process and the decision

criteria stopped and the Judgement of the

equivalence of sanitary measures work progressed

in isolation

• This guidance (CAC/GL 53-2003) primarily

focussed on judgements of specified sanitary

measures, although some effort was made to

extrapolate this same approach to possibly an

equivalence decision of the whole system



• CAC/GL 53-2003 is still a useful guidance

for situations where countries just want to

compare individual measures but arguably

has less utility for the comparison of whole

systems unless they have a very similar

structure


What’s missing?

• With the ever increasing globalisation of trade involving

more countries and many more product/ ingredient types

there is an increased need for countries to look at

equivalence as a tool to facilitate trade.

• To do so there is a need to focus more on whether an

exporting country’s “food control system”, or relevant

part, is credible and likely to achieve the Importing

country’s overarching public health and fair practice in

the food trade objectives

– As opposed to historical approaches which often involve using a

an detailed side by side comparison of specific measures or

procedures (measure by measure)


New Work on Systems Equivalence

• After consideration of two discussion papers

(2016 and 2017) on the gaps in the current

guidance and the pressing trade needs for a

new solution, in 2017 CCFICS recommended to

the CAC that work on the Use of Systems

Equivalence be initiated

• There has been a very active process of two

electronic working groups and two physical

working groups since (up to draft 4)


Systems Equivalence Approach

• Consistent with the original Codex guidance

(CAC/GL 26-1997 and CAC/GL 34-1999), but

• Has been further informed by the most recent

thinking and Codex guidance on NFCS and

Information Exchange to support trade in food

(CAC/GL 82-2013 and CAC/GL 89-2016)


Why is New Zealand leading this process

• New Zealand has some of the most comprehensive

system equivalence and system recognition agreements

in the world – we have more experience than most

• However, being a small trading nation we also have a lot

of experience of duplicative importing country process

prescriptive requirements and establishment listing

audits being imposed upon us

• This is even though the credibility of our NFCS / FICS is

recognised by the world’s most discerning markets and

more than meets the relevant international standards


Why is New Zealand leading this process

• New Zealand Chaired the Codex Committees that

developed the Recommended Codes of Hygienic

Practice for both Dairy and Meat Products – the most

regulated commodities in international trade

• New Zealand also chaired the recent Information

Exchange Guidance to Support Trade in Food – for

which a systems equivalence assessment is arguably a

natural evolution


What is a Systems Equivalence Approach

• Top down (helicopter) approach that looks at the

design of the system as a whole, or relevant

part, as opposed to a bottom up measure by

measure approach (down in the weeds).

• Potentially covers both the full scope of a

countries NFCS and the mandate of Codex –

both the protection of public health and ensuring

fair practices in the food trade (CAC/GL 53-2003

only covers specified Sanitary measures)


In Conclusion

Current Codex guidance on Equivalence still has a

role [possibly with some consequential amendments] with

respect to:

• Providing the overarching principles and context

(CAC/GL 26-1997 and CAC/GL 82-2013)

• Providing guidance on the development of Equivalence

Agreements (CAC/GL 34-1999), and

• Providing guidance where more intensive assessments

of the equivalence of specified sanitary measures may

be required / justified (CAC/GL 53-2003).


However in many situations focussing on

• System Equivalence assessments, and associated

Equivalence Agreements that further enhance co-

operation between the competent authorities of

exporting and importing countries, is likely to be

more efficient and effective than focusing on the

detailed comparison of specific procedures

• Either way it is likely to be a more sustainable and

resource efficient option than some country’s

current detailed questionnaire and establishment

inspection procedures


Effect of a System Equivalence Recognition

• Whatever the two countries agree to put in the

agreement documenting it –totally in your control

• Could just be a recognition of country

establishment lists or could also provide for a

degree of reduced border inspection or could go

much wider

• Is not a blank check, but is about enhanced co-

operation


It’s also about putting Risk in Perspective


Thank you