Here's the latest data on Codex. The last I heard was that 2,000 healthfood stores in France have closed. If anyone has further information regarding Codex and the EU please pass it along to the list. Thanks. jDoc

[Guest guest]

United States Food

Safety Washington,

D.C.

Department of and

Inspection 20250

Agriculture Service

 

Dr. Rolf Grossklaus

Chairman of the Committee

Bundesinstitut für Risikobewertung (BfR)

P.O.Box 33 00 13

14191 Berlin

Germany

 

Dear Dr. Grossklaus:

 

The United States of America is pleased to provide comments on the

Proposed Draft Guidelines for Vitamin and Mineral Food Supplements at Step 4.

 

We would appreciate these comments being made available in a Conference

Room Document at the 25th Session of the Codex Committee on

Nutrition and Foods for Special Dietary Uses.

 

COMMENTS

 

General Comments

 

Since this is a guideline,

rather than a standard, we recommend changing “shall” and “must” to “should”

throughout the document.

 

Comments on Specific Sections

 

1.

SCOPE

 

1.2 It is

left to national authorities to decide whether vitamin and mineral supplements

are drugs or foods. These

Guidelines do apply to in those jurisdictions where food

products defined in 2.1. are regulated as foods.

 

Rationale:

Codex

Alimentarius guidelines only apply to products in international trade and that

are regulated as foods. Therefore,

reference to regulation as drugs or deference to national authorities are

unnecessary.

 

2.

DEFINITIONS

 

2.1 Vitamin and

mineral supplements for the purpose of these guidelines derive their

nutritional relevance primarily from the minerals and/or vitamins they

contain. Vitamin and mineral

supplements are sources in concentrated forms of those nutrients alone or in

combinations, marketed in capsules, tablets, powders, or solutions,

and are not

 

 

 

represented for use as conventional

foods. etc., not

in a conventional food form and do not provide a significant amount of

energy. [They serve to supplement

the daily diet with these nutrients in cases when the intake from food is

insufficient or where the consumers consider their diet requires

supplementation.]

 

Rationale:

a)

The

current language of “not in a conventional food form” would appear to be

unnecessary given previous language as to marketed forms (e.g., capsules,

tablets). The suggested language

of “not represented for use as conventional foods” would seem to support the

Preamble concept that these products are supplements and should not be a

substitute for a balanced diet.

b)

The

meaning of the phrase “do not provide a significant amount of energy” is not

clear and appears unnecessary.

Moreover, we are unaware of an accepted definition of the concept of “a

significant amount of energy”.

c)

The

last sentence is unnecessary. It

is redundant with the information in the Preamble.

 

3.

COMPOSITION

 

3.1

SELECTION OF VITAMINS AND

MINERALS

 

3.1.2 The selection of

admissible chemicals used as sources of vitamins and minerals sources

should be based on considerations criteria such as

safety and bioavailability. In

addition, purity criteria should take into account the FAO/WHO standards,

or, if

FAO/WHO standards are not available, international Pharmacopoeias or

recognized international standards.

In the absence of criteria from these sources, national legislation may

be used. [and national legislation, where applicable].

 

Rationale:

a)

The word “admissible” does not seem necessary.

b)

Reference to “chemicals used as sources” should clarify the

differences between 3.1.1 and 3.1.2.

c)

Specific reference to national legislation runs contrary to

the spirit of international fair trade practices. Specific reference is not necessary because it is protected

under provisions of the WTO agreements.

Any reference to national legislation should only be made when international

standards are not available.

 

[3.1.3 The use of individual vitamins

and minerals in supplements can be [limited] for reasons of health protection

and consumer safety, taking into account regional or national peculiarities

concerning the supply situation of the population].

 

 

 

Rationale:

The intent

of this provision is not clear. If

it is intended to limit the levels of vitamins and minerals in a product based

on safety considerations, then it is more appropriately addressed in provisions

covered by Section 3.2 on “Contents” than in section 3.1 on “Selection”.

 

3.2

CONTENTS OF VITAMINS AND

MINERALS

 

3.2.1

The

minimum level of each vitamin and/or mineral contained in a vitamin and mineral

supplement per daily portion of consumption as suggested by the manufacturer

should be equal

to or greater than [15% to 33%] of the recommended nutrient daily

intakes

(RNIs) as determined by FAO/WHO.

 

Comments:

a)

Under

nutrition labeling standards, a level of 15% of the NRV for a vitamin and

mineral is generally deemed necessary to support a nutrient content claim. This suggests that it is a meaningful

amount and therefore provides a rational basis for a minimum level for vitamin

and mineral supplements, if a minimum level is deemed necessary. We are unaware of a logical basis for

the 33% level.

b)

The

minimum level of 33% may be difficult to achieve for some minerals (e.g.,

calcium and magnesium) where their bulk alone may make it difficult to achieve

a 33% level, particularly where several of these minerals are present in a product.

c)

We

also recommend the removal of the square brackets around the 15% level.

d)

The

use of the term “nutrient” in place of “daily” is consistent with the

terminology used in the FAO/WHO expert consultations on vitamin and mineral

requirements.

 

3.2.2 [The maximum level of each

vitamin and/or mineral contained in a vitamin and mineral supplement per daily

portion of consumption as suggested by the manufacturer should not exceed

[100%] of the recommended daily intake as determined by FAO/WHO.]

 

Rationale:

We

believe that the setting of maximum levels, when needed, should be derived from

science-based risk assessments of safety (as is done in the second option for

3.2.2 below). Moreover, the

recommended daily intakes as determined by FAO/WHO are inappropriate in this

context as safety considerations are not used in their development. We also

recommend the removal of the square bracket around the second option for 3.2.2

below.

or

 

3.2.2 [Maximum amounts of

vitamins and minerals in vitamin and mineral supplements per daily portion of

consumption as recommended by the manufacturer should shall be set, takeing

the following criteria into account:

 

Rationale:

As

a guideline rather than a standard, the use of “should” rather than “shall” is

appropriate.

 

(a)

upper

safe levels of vitamins and minerals established by scientific risk assessment

based on generally accepted scientific data, taking into consideration, as

appropriate, the varying degrees of sensitivity of different consumer groups;

(b)

the

daily intake of vitamins and minerals from other dietary sources.

 

When

the maximum levels are set, due account should be taken to the reference intake

values of vitamins and minerals for the population.]

 

Comment:

We

are unclear as to the meaning or purpose of this last statement. It would appear to already be an

integral part of the scientific processes involved in both options stated

above. In the absence of a clear

need for this sentence, we recommend deleting it.

 

3.2.3 For vitamins an minerals

with a narrow safety margin between the recommended daily intake and the

adverse effect level, different maximum limits for the daily dose may be

established at the national level.

 

Rationale:

a)

Safety

issues, including those relating to vitamins and minerals with a narrow safety

margin, would be covered by the provisions in 3.2.2.

b)

If

a particular nationality has an unusually high dietary level of a particular

nutrient with a narrow safety range, provisions under the WTO agreements

already allow that nation to deviate from international standards based on

scientific justification. Thus,

this provision is unnecessary.

 

4. PACKAGING

 

4.1 The product

should

shall be packed in containers which will safeguard the hygienic and

other qualities of the food.

 

4.2 The

containers, including packaging material, should shall be made only of

substances which are safe and suitable for their intended use. Where the Codex Alimentarius Commission

has established a standard for any such substance used as packaging material,

that standard shall apply.

 

5. LABELLING

 

5.1 Vitamin and

mineral supplements should be are labeled according to

the Codex Standard for the Labelling of Prepackaged Foods (Codex-Stan 1-1985,

Rev. 1- 1991) as well as according to the General Guidelines on Claims (CAC/GL

1-1979).

 

[5.2 The name of the

product should

shall be “vitamin and mineral supplement”, or “dietary mineral/vitamin

preparation to supplement the diet with …” with an indication of the nutrients

contained therein, or “food supplement”, or “dietary supplement”.

 

Rationale:

Specific

identification of “vitamin and mineral” in the name is unnecessary as the

nutrient declaration in the labeling will make clear that the product contains

vitamins and minerals.

 

[5.3 The

amount of the vitamins and minerals present in the product should shall be

declared in the labeling in numerical form. The units to be used should shall be units of weight. consistent

with the Codex Guidelines on Nutrition Labelling.

 

Comment:

We

also recommend the removal of the square bracket for 5.3.

 

5.4 The amounts

of the vitamin and minerals declared should shall be those amounts per

portion of the product as recommended on the labeling for daily

consumption, and if different, the amounts per single use. on the

labelling and per unit dose form as appropriate.

 

Rationale:

The

use of the term “dose” inappropriately implies a drug use instead of a food

use.

 

5.5 Numerical

Information on vitamins and minerals should shall also be expressed as a

percentage of the reference values mentioned, as the case may be, in the Codex

Guidelines on Nutrition Labelling.]

 

Rationale:

Provides

clarification as to the intent of this provision and is consistent with the

Codex Guidelines on Nutrition Labeling, para 3.4.4 (CAC/GL2-1985(Rev 1-1993)).

 

5.6 The label should must

indicate the recommendations on how to take the product (quantity,

frequency, special conditions).

 

5.7 The label

must contain a warning statement [if the product contains a significant amount

of a nutrient with respect to the toxicity level.]

 

Rationale:

There

is no need for a warning statement relative to nutrient levels because a

product that meets the provisions in 3.2.2 would not contain unsafe nutrient

levels.

 

[5.8 The label must

should

not state or imply that contain a statement: supplements can not

be used for the replacement of meals or a varied diet. on long term basis.

 

Rationale:

With

limited label space, prevention of misleading information is more practical

than requiring additional information.

Moreover, crowded labels may lead to consumer confusion or failure to

read all information. We also

recommend the removal of the square bracket for 5.8.

 

5.9 All labels

shall bear a statement that the supplement should be taken on an advice of a

nutritionist, a dietician or a medical doctor.]

 

Rationale:

This

statement is not necessary because products that meet the provisions in this

Guideline would be safe, truthfully labeled, and suitable as foods. Moreover, reference to use on the

advice of health professionals may mislead consumers into believing it is

useful as a drug rather than as a food product.

 

We look forward to the discussions at the Session. Thank you for your help.

 

Sincerely,

 

 

 

 

 

F. Edward Scarbrough, Ph.D.

U.S. Manager for Codex

Office of the Administrator

 

USDA:FSIS:U.S. Codex:EMatten:ls;202 205 7760:10/15/03:Proposed Draft

Guidelines for Vitamin and Mineral Food Supplements at Step 4

 

 

 

 

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