Dairy Ingredients for Food Processing

Dairy-based Ingredients: Regulatory Aspects 383

* That the proper test data will be

submitted

* That the analytical methodology will be

adequate

* That the validation methodology will be

adequate

• Submit all supporting raw data, including
  that for:
  
  
  • Samples
  
  
  • Standards
  
  
  • Construction of calibration curves
  
  
  • Determination of limits of detection
    (LOD) and limits of quantitation (LOQ)
  
  
  
  


• Submit a complete description of the ana-
  lytical methods, including:
  
  
  • Sample workup
  
  
  • Preparation of standards
  
  
  • Example calculations
  
  
  
  


• Submit all other relevant information, for
  example:
  
  
  • Technical brochures
  
  
  • Material safety data sheets (MSDS)
  
  
  • Methodology and calculations for esti-
    mating intake
  
  
  • References, as appropriate (in English)
  
  
  
  


• Discuss the results: interpretations and
  conclusions should be scientifi cally sound
  and supported by the data.


• Do not make any unsupported statements.
  According to an FDA guidance document,
  information allowing the unequivocal identi-
  fi cation and characterization of the food addi-
  tive should be provided. Such items include:

1. Formal chemical name. The Chemical
   Abstracts Service (CAS) or International
   Union of Pure and Applied Chemistry
   (IUPAC) name of the additive is
   acceptable.


2. Common names, synonyms, or trade
   names.


3. Chemical Abstracts Service (CAS) reg-
   istry number. Providing CAS registry
   numbers for a petitioned food additive

According to the FDA, the basic elements
of a safety assessment for an additive are as
follows:

1. Identity


2. Probable exposure


3. Evaluation of safety


4. Limitations of conditions of use (may be
   necessary to ensure safe use)
   According to the FDA, the following are
   essential elements of a food and/or color
   additive petition:

• The identity and composition of the additive


• Proposed use


• Use level


• Data establishing the intended effect


• Quantitative detection methods


• Estimated exposure from the proposed use
  (in food, drugs, cosmetics, or devices, as
  appropriate)


• Full reports of all safety studies


• Proposed tolerances (if needed)


• Environmental information (as required by
  the National Environmental Policy Act;
  NEPA), as revised (62 FR 40570; July 29,
  1997)
  Ensure that consistent information is pre-
  sented throughout all sections of the petition,
  including those pertaining to chemistry, toxi-
  cology, environmental science, and any other
  pertinent studies (e.g., microbiology).
  For a food additive petition, the following
  is recommended by FDA to be appropriate
  chemistry information:


• The design of any study and assessment
  of the results should be based on sound
  scientifi c principles, not rote adherence to
  guidelines.


• Signifi cant deviations from appropriate
  guidelines should be justifi ed and possible
  effects on the study discussed.


• Consult with the Offi ce of Food Additive
  Safety (OFAS) for protocol review before
  initiating any studies to ensure: