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Quality Assurance

Developing Raw Material

Specifications By Robin Amsbary

ow many calls have you received recognized food allergens
from the production or receiving • Organoleptic information (appearance,
department concerning problems flavor and aroma)
with a raw material? How many complaints • Pertinent physical, chemical and micro-
have you received from upset customers? biological information
Unfortunately, these calls are more common • Shipping and storage information
than we like. The most common reason for • Handling directions
the problems is that expectations are not
clearly communicated. PRODUCT NAME. The material identifi-
The first step toward resolving issues is cation can be general for commodity-type
to understand the materials being purchased products or those with a standard of identity,
and to document your expectations in your such as salt, granulated sugar, FD&C Yel-
raw material specifications. While suppliers low No. 5, and so forth. General names or
may provide baseline information with their descriptors ease use and sharing specifica- Make sure to get the specific list of the allergens
finished product specifications or technical tions, especially when soliciting and com- used in a product from your suppliers.
data sheets, this should be transferred to paring bids or purchasing from multiple
your own format. The reasons for develop- suppliers.
ing your company-specific raw material The ingredient-identifying name as- Step One — Develop a company-specific
specifications include: signed by the supplier may be necessary allergen list, considering the following fac-
• Some supplier’s specifications may pro- when the item is a unique or proprietary tors:
vide only a target or “typical” range for material. The specific name of the material  Regulated Allergens — There is not a
some characteristics. purchased can then be supplied to the receiv- globally recognized list of regulated
• Your finished product may require ing function so that they can confirm that food allergens, so you need to know the
additional certifications for the label the correct item is being delivered. regulations for the countries where your
declarations, such as Country of Origin, product is distributed. For example, the
Natural, Kosher, or Organic. COMPONENTS. Outline the material’s United States has regulations addressing
• Your company may be controlling or composition, in decreasing order of pres- the proteins from eight food sources:
ensuring labeling for additional food ence or as outlined in labeling regulations. milk, eggs, fish, peanuts, shellfish, soy,
allergens other than those regulated by The Hazard Analysis Critical Control Point tree nuts and wheat. Canadian regula-
American or Canadian agencies. (HACCP) Team and the group that devel- tions recognize the same eight groups, as
• A uniform internal system improves ops your finished product label will need well as sesame seeds (as an allergen) and
communication of the specifications a list of all the ingredients used, including sulfites (for food intolerance).
throughout the plant. processing aids. For packaging materials, the  Customer-Identified Allergens — Some
• If seeking secondary suppliers of a raw specific composition of the packaging mate- of your customers have their own, ex-
material, the process is simplified by rial would be needed, such as glass, polyeth- panded allergen/food intolerance lists to
sending your specifications for what is ylene (PET) or polypropylene (PPE). encompass their label declarations or in
being sought. recognition of the regulations in countries
FOOD ALLERGENS. A supplier’s technical where their products are distributed.
At a minimum, your raw material speci- data sheet often will state that the material Step Two — Provide your company-specific
fications should include technical and food does not contain an allergen; however, the allergen list to the raw material supplier,
safety information, including: specific list of the allergens used to make this including suppliers of your processing aids
• The name of the product statement may not be included. There are and food contact packaging material. If there
• The ingredient’s components three steps to take before you can be sure that is any allergenic material in the product,
• The presence of regulated or customer- the necessary information is provided. regardless of the amount, it must be identi-


fied on the label. • Biological — Microbiological limits for • Generally Recognized As Safe (GRAS)
pathogens (Salmonella, Listeria monocy- items are also listed in the CFRs. If the
Step Three — The supplier is to review their togenes, E. coli). material you are purchasing falls into this
material purchased in conjunction with your category, identify the CFR listing that
allergen/food intolerance list. They then Functionality or quality parameters identifies it as being GRAS.
provide a documented list of all the allergens include those that can impact the functional- • Other CFR listing — The FDA and
they reviewed and identify those that are in ity of the material or adversely impact your USDA also assess food chemicals and
the product, if any. product. This could include: food contact packaging raw materials
• Chemical — Characteristics such as con- to determine if they are appropriate
ORGANOLEPTIC INFORMATION. Or- centration levels or purity. for food. Know where in the CFR the
ganoleptic characteristics are tested for • Physical — Characteristics such as viscos- product you are purchasing is referenced
visual appearance, aroma and flavor. This ity, granulation size, insect parts, crush as being appropriate.
brief description is used typically during the strength and physical measurements. • Color information — The FDA and
receipt or pre-use at the plant to confirm that • Biological — Microbiological limits for USDA assess food colors to determine if
basic expectations are met or identify issues spoilage organism or indicators of poor they must be a “Certified Color” (such as
that can be readily checked by appearance sanitation, including total plate count, Yellow No. 5, Red No. 40) or “Exempt
(puree rather than whole fruit), smell (off yeast and mold. from Certification.” Exempt colors are
odors such as musty, soapy or chemical) or typically listed as GRAS.
taste (caramelized high fructose corn syrup SHIPPING & STORAGE. Outline the ap- • Flavor information — Is the flavor artifi-
or rancid oil). propriate conditions for shipping and stor- cial and/or natural?
ing the material. Temperature requirements • Organic — Does the material meet the
ANALYTICAL INFORMATION. Analytical would include ambient, refrigeration or definition of organic as outlined in the
characteristics typically are tests requiring frozen. There also can be special storage or “National Organic Program” [regulated
instruments rather than your senses. For handling directions, such as “do not freeze” by the USDA (7 CFR 205)]?
example, an organoleptic description of or “store in a flame-resistant cabinet.” • Potential legal limits — Be familiar with
a product could be “red liquid” and the specific levels at which food additives are
analytical information would be the Color- HANDLING INFORMATION. Determine toxic or carcinogenic, as outlined in the
imeter reading. Characteristics to be outlined if there are additional steps affiliated with CFRs.
include those affiliated with functionality, handling or using the material, such as “shake • California Proposition 65 — Does the
quality and food safety. the material before use” or “apply only in well product or components within the prod-
Determining the key biological, chemi- ventilated area.” uct meet the declaration requirements as
cal and physical parameters requires historic outlined in California Proposition 65?
information about the material, regulatory OTHER INFORMATION. Additional infor-
requirements and the supplier’s capability. mation concerning a new or revised material CERTIFICATE OF ANALYSIS. A Certificate
A comprehensive evaluation to determine may be vital to your company and customer. of Analysis (CoA) is the supplier’s report of
the key characteristics’ affiliated parameters You may wish to stipulate these requirements the test results from a specific lot of mate-
(target and range) requires research as well in the raw material specification. The follow- rial. Tools for determining what tests should
as knowledge from the Research and De- ing list is not all encompassing; however, all be reported, report format and periodic
velopment and Quality departments, and should be considered when developing a raw validation of the results will be discussed in
the supplier. material specification: a future article.
For example, microbiological standards
for granulated salt would not be pertinent, Material quantity and packaging SUMMARY. A clear understanding of the
though they would be necessary for ready- Outline the packaging material containing materials being purchased is vital for sup-
to-eat meats. Another example is that the the raw material being purchased such as pliers and customers. Materials that do not
granulation size for the salt may be critical weight, multi-layered paper bag; poly-lined meet your expectations can significantly
for a potato chip manufacturer (topical ap- corrugated container; or bulk tanker. impact quality, reduce productivity, increase
plication), but not as important for a product cost due to additional testing or clean up,
where the salt is dissolved. Food safety pa- Religious requirements and place your product, company, customers
rameters or tolerances could include: Does your finished product label include a and consumers at risk for hazardous issues.
• Chemical — Characteristics such as for- kosher or halal symbol? If so, the specifica- Purchasing and using desired raw materials is
tification levels, sulfite levels and heavy tion must indicate the requirements. a key building block toward making a consis-
metal content. tent, high-quality finished product. AIB
• Physical — Characteristics such as size Regulatory information
and foreign material (rocks, glass, metal • Standard of Identity — outline the Code The author is HACCP Coordinator at AIB Inter-
and bones). of Federal Regulations (CFR) listing national.