equivalence - Cclac.org

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equivalence - Cclac.org

EQUIVALENCE OF CONTROL

SYSTEMS

ITS SIGNIFICANCE IN FOOD

SAFETY AND TRADE

Dr. Maya Piñeiro, Ph.D.

Senior Officer

Food Quality and Standards Service

Nutrition and Consumer Protection Division

AGNS, FAO

1


THE PROBLEM OF ANY

MEASURE TO BE ADOPTED

It should balance opposing requirements

between:

Regulatory autonomy at domestic level, and

• Promoting social objectives (Health, Food

Security)

• Facilitating trade

• Not hiding protectionist practices

2


EQUIVALENCE

Equivalence was last defined in 2004 for the SPS

Agreement as:

Mutual acceptance of another

member’s standards which, although

different, have the same effect.

3


EQUIVALENCE AND MUTUAL

RECOGNITION

• Equivalence: recognizing that different

control systems can reach the same

objective: it normally refers to specific

sanitary or phytosanitary measures.

• Mutual Recognition: two trading

countries recognize one another’s

control procedures as valid: they may

cover all foods or specific foods.

4


EQUIVALENCE

Equivalence is about obtaining the same

results rather than to the methods used to

do this: for example, accepting different

measures that achieve the importing

country’s appropriate level of protection.

Equivalence is thus a different concept

than mutual recognition, certification,

conformity or harmonization.

5


EQUIVALENCE

‣ The SPS Agreement makes a general

reference to equivalence for sanitary and

phytosanitary measures.

‣ The TBT Agreement assumes that the

international standards it promotes are

already equivalent, and so technical

regulations and conformity assessment

procedures should, if based on such

international standards, be considered

equivalent.

6


EQUIVALENCE

‣ The concept means recognizing that the

same objective (the Appropriate Level of

Protection - ALOP) can be reached with

different measures.

‣ Operationally, procedures should be set

and adopted to confirm that the same

objective is reached.

‣ OBC (Objective Basis of Comparison)

Tools to demonstrate ALOP equivalence.

‣ Its scope needs to be extended to

individual products or product groups.

7


EQUIVALENCE IN THE SPS

AGREEMENT

The SPS Agreement makes explicit reference to

equivalence in Article 4, Equivalence

1. “Members shall accept the sanitary or phytosanitary

measures of other Members as equivalent, even if these

measures differ from their own or from those used by other

Members trading in the same product, if the exporting

Member objectively demonstrates to the importing Member

that its measures achieve the importing Member's

appropriate level of sanitary or phytosanitary protection.

For this purpose, reasonable access shall be given, upon

request, to the importing Member for inspection, testing

and other relevant procedures

2. Members shall, upon request, enter into consultations with

the aim of achieving bilateral and multilateral agreements

on recognition of the equivalence of specified sanitary or

phytosanitary measures”

8


EQUIVALENCE IN THE TBT

AGREEMENT

The TBT Agreement makes indirect reference to equivalence:

‣ Art. 2.7 “Members shall give positive consideration to

accepting as equivalent technical regulations of other

Members, even if these regulations differ from their own,

provided they are satisfied that these regulations

adequately fulfil the objectives of their own regulations”.

‣ Art. 6.1 “Without prejudice to the provisions of paragraphs

3 and 4, Members shall ensure, whenever possible, that

results of conformity assessment procedures in other

Members are accepted, even when those procedures differ

from their own, provided they are satisfied that those

procedures offer an assurance of conformity with

applicable technical regulations or standards equivalent to

their own procedures. It is recognized that prior

consultations may be necessary in order to arrive at a

mutually satisfactory understanding regarding, in

particular…”

9


HOW IS EQUIVALENCE

ACHIEVED

‣ The SPS Agreement recommends “Members

shall, upon request, enter into consultations with

the aim of achieving bilateral and multilateral

agreements on recognition of the equivalence of

specified sanitary or phytosanitary measures.”

(Art. 4.2)

‣ The TBT Agreement states “Members are

encouraged, at the request of other Members, to

be willing to enter into negotiations for the

conclusion of agreements for the mutual

recognition of results of each other's conformity

assessment procedures.” (Art. 6.3)

10


HOW IS EQUIVALENCE

ACHIEVED

‣ The Agreements provide no specific

guidance other than parties’ implicit

willingness to facilitate trade.

‣ For this reason, the Codex Alimentarius

Commission has developed guidelines for

the measures provided for in the SPS

Agreement.

‣ At the WTO, some members and

multilateral organizations have made

suggestions and comments.

11


ACHIEVIING EQUIVALENCE

‣ Equivalence agreements (treaties, exchange of

correspondence and memoranda of

understanding) are necessary to facilitate trade,

reducing costs for consumers.

‣ There remain a large number of challenges

associated with the judgement of equivalence.

‣ There are relatively few operational agreements

on recognition.

‣ Work needs to be continued.

12


DIFFICULTIES ENCOUNTERED IN

ACHIEVING

EQUIVALENCE

“equality” instead of “equivalence

It is inappropriate to request the exporting

country to demonstrate that its measure is

equal to that of the importing country.

Rather, it should demonstrate it is

equivalent in order to achieve the required

level of protection.

13


DIFFICULTIES ENCOUNTERED IN

ACHIEVING

EQUIVALENCE

Achieveing equivalence may require significant

resources and lengthy negotiations with high

administrative costs.

‣ It is worth remembering that equivalence is a

trade facilitation measure;

‣ As such, it should be as cost-effective as

possible;

‣ Product lists need to be analyzed on a bilateral

basis, taking into consideration associated risk

levels and stressing the history, confirmed by

historical records including rejections.

14


DIFFICULTIES ENCOUNTERED IN

ACHIEVING

EQUIVALENCE

The importing country should set its appropriate level of

protection, and the exporting country should satisfactorily

demonstrate that it can achieve it with its own measures

This implies:

‣ Very clear identification of the level of protection required

by the importing country;

‣ Explanation of the purpose of the measure and

identification of the risk it intends to avoid;

‣ Provision of scientific information supporting the

recognition of equivalence;

‣ Provision of technical assistance to help identify and

implement measures recognized as equivalent.

15


DIFFICULTIES ENCOUNTERED IN

ACHIEVING

EQUIVALENCE

International guidance on equivalence

need to be available so that the

principle may be applied consistently

The CAC (CCFICS) has prepared

guidelines, but active ongoing

participation of Member Countries in the

development of these texts is essential.

16


EQUIVALENCE AND CODEX

• The adopted “Principles for Food Import

and Export Inspection and Certification”

state:

“Countries should recognize 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.”

17


EQUIVALENCE AND CODEX

• The “Guidelines for the Design, Operation,

Assessment and Accreditation of Food Import and

Export Inspection and Certification Systems” state:

“The recognition of equivalence of inspection and

certification should be facilitated where it can be

objectively demonstrated that there is an

appropriate system for inspection and certification

of food by the exporting country in accordance with

these guidelines.”

18


EQUIVALENCE AND CODEX

• The “Guidelines for the Development of

Equivalence Agreements…”

• Guidelines on the Judgement of Equivalence of

Sanitary Measures Associated with Food

Inspection and Certification Systems (2003)

• Appendices being prepared

19


EQUIVALENCE AND CODEX

The guidelines also state that :

• The same food produced in different places

may result in different hazards;

• Control methodologies may be different but

they should produce the same results;

• Imported and domestic food control should

be designed to ensure the same level or

protection;

• Unnecessary control duplication should be

avoided.

20


DIFFICULTIES ENCOUNTERED IN

ACHIEVING

EQUIVALENCE

Transparency in equivalence

agreements and confidence in the

equivalence judgment process is

needed

Contact Points could provide information

on concluded agreements as well as the

terms and criteria adopted.

21


SOME REQUIREMENTS TO REACH

EQUIVALENCE AGREEMENTS

‣ The (legal and regulatory) infrastructure, specific

requirements (facilities, equipment, processes,

procedures and tests ), scope and required levels

of protection need to be available.

‣ Difficulties may be encountered during

negotiations and eventually hinder progress at

some stage, particularly when analyzing facilities;

assessing laboratories and systems for efficient,

qualified inspection; and performing audits and

early warning systems.

22


CONSIDERATIONS

‣ Reaching a balance between a more structured

approach and another providing more flexible

options also facilitating trade: exchange of

correspondence or MOU,

‣ Defining the scope (including individual products

or sectors),

‣ Clearly defining the involved parties,

‣ Bearing in mind the history,

‣ Access is not necessarily limited, for some

countries, to equivalence agreements, except for

sensitive sectors (meat and poultry).

23


BENEFITS OF AGREEMENTS ON

MUTUAL RECOGNITION

• Assuring consumers of an appropriate level

of protection,

• Better joint use of resources,

• Trade facilitation and elimination of delays at

ports of entry,

• Less dependence on routine inspections

• Harmonization of food regulations and

control systems,

• Quick solutions to problems

24


CONCLUSION

• Agreements on mutual recognition and

equivalence have the potential to

facilitate trade and reduce costs

• A number of challenges associated with

how to judge equivalence

• CCFICS actively works on the

development of guidelines on these

matters

25

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