AnnexureII
    GUIDANCE DOCUMENT ON VERTICAL STANDARDS

I. As may be observed from the Strategy document, it is aimed at starting this work for developing the vertical standards. It is proposed to cover products where we have domestic standards under FSSR but these need a revision/harmonization with those of the Codex and other international best practices. Further, it also proposed to cover those products where we do not have domestic standards under FSSR but a relevant Codex standard is available.
II. The list of ‘Vertical Standards’not specifically provided for under FSSR regulations but adopted by FAO/WHO Codex Alimentarius Commission is given below:

Attachment 1-list of vertical standards

The codex standards for these products will be reviewed and new standards be suggested in thefollowing format, for these categories or standards or products mentioned therein.


Introduction
The format indicates the statements which should be included in standards as appropriate under the relevant headings and may be modified to meet the intended objectives:
1. Name of the Standard
2. Scope
3. Description
4. Composition and Quality Factors
5. Food Additives
6. Contaminants, Toxins and Residues
7. Hygiene
8. Packaging, Labeling and Claims
9. Methods of Analysis and Sampling
10. Processing Aids
Notes on the Headings:
1. Name of the Standard
The name of the standard should be clear and as concise as possible.
2. Scope
This section should contain a clear, concise statement as to the food or foods to which the standard is applicable. In the case of a general standard covering more than one specific product, it should be made clear as to which specific products the standard applies.
3. Description
This section should contain a definition of the product or products with an indication, where appropriate, of the raw materials from which it is derived and any necessary references to processes of manufacture. It may also include references to types and styles of product and to type of pack. There may also be additional definitions when these are required to clarify the meaning of the standard.
4. Composition and Quality Factors
This section should contain all quantitative and/or other requirements as to composition including, where necessary, identity characteristics, provisions on packing media and/or requirements as to compulsory and optional ingredients.
It may also include quality factors which are essential for the designation, definition or composition of the product concerned. Such factors may also include the quality of the raw material, quality criteria for the finished products and/or provisions on taste, odour, colour and texture.
The substance(s) which may need to be restricted for this standard and/or products mentioned herein may be provided in this section. The scientific rationale (links/references from expert consultations of WHO&FAO or JECFA/JMPR/JEMRA/JEMNU or otherinformation source from peer reviewed scientific journals or other regulatory agencies) for this restriction should also be provided.
Information specific to these vertical standards as per sections below (Sections 5-10) is to be given in enclosed formats. These will then be later become a part of the relevant horizontal standards.
If an expertworking group[referred to in Para No. 3 of the Strategy document (Annexure I)]on a particular standard is of the view that risk assessment is needed for particular parameter(s) like Contaminants, Food Additives or Microbiological Criteria, this may be mentioned in the relevant sections by the expert working group.
5. Food Additives
This section should contain a general reference to the corresponding Codex General Standard for Food Additives (GSFA). The guidance document for providing inputs suitable for this standard or products mentioned herein or category for this section is in Attachment 2 below.

Attachment 2-Guidence Document

This section needs to be commented onand developed in two parts:
a. In Excel sheets (Attachments 3 and 4) with guidance from Table 2 of the Codex GSFA (Attachment 5). These are based on Indian Food Categories and will require inputs of allowances mainly from Codex or other national/international regulations as per links provided in the sheet. The objective here is toprepare the list of permitted substances.

Attachment 3-Format for Food Additives (Part - I)
Attachment 4-Format for Food Additives (Part - II)
Attachment 5-Table 2 of Codex GSFA

b. In Excel sheet (Attachment 6) based on Table 3 of the Codex GSFA (Attachment 7) in case any modifications are suggested. The objective here is to prepare the list of substances permitted to be used on GMP basis.

Attachment 6-Format for Additives
Attachment 7-Table 3 of Codex GSFA

6. Contaminants, Toxins and Residues
This section should contain a general reference to the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011. This section needs to be commented in the Excel sheets(Attachments 8 and 9) provided below and be based on the Codex General Standard for Contaminants and Toxins in Food and Feed (Attachment 10):

Attachment 8-Format for Contaminants (Part - I)
Attachment 9-Format for Contaminants (Part - II)
Attachment 10-Codex General Standards

While commenting on this sheet the relevant Codex standards or Guidelines and/or other national/international regulations may be taken into account.
7. Hygiene
This section should provide Specific requirements for the product based on Recommended Code of Practice given by Codex or International Commission for Microbiological Specifications for Foods (ICMSF).Working groups may refer to Codex Standards, Guidelines or limits for any microbial contaminants for filling up this section. A comparative statement for these limits with national/international regulations shall also be given.
8. Packaging, Labeling and Claims
Any specific labeling requirements for the product or changes in the existing labeling requirements may be given under this section. Suggestions for claims may be given as per the Excel sheet (Attachment 11)given below and these suggestions must be based on international models for claim regulations and the justifications for the same may alsobe provided.

Attachment 11-Format for Claims

This section should also include a general reference to Food Safety and Standards (Packaging and Labeling) Regulations, 2011.
9. Methods of Analysis and Sampling
Under this section, propose internationally validated reference (like AOAC, ISO, Food Chemical Codex, AACC, AOCS, Codex, IAEA) methods to be used for regulatory/enforcement purposes. The limit of quantification of such methods should be adequate as per the regulatory limits proposed.While filling up this section, care must be taken that the laboratories performing these methods must be complying toISO/ IEC- 17025.The methods under this section must be given only for those parameters which are specific to this standard. This section may also contain a reference to analysis manual on FSSAI website.
10. Processing Aids:
This section should specify any processing aid(s) suitable for this standard or products mentioned herein or category at Maximum Level of Use in line with Good Manufacturing Practices (GMP).

III. The format for commenting on changes required in vertical standards currently available under FSSR which may needharmonization is given below (please see Excel Sheet in Attachment 12).

Attachment 12-FSSR Standard for review

The expert group working on a standard is expected to prepare a complete draft standard for food products. Further, they may decide to use an alternate template if found more suitable. Reasons for this change of format must be recorded. If the Working Group feels that there is a need to re-write a standard, then the same can be done provided the justification for that is available. This re-written standard shall be as per the format provided in the ‘Introduction’ para of this document.

 
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