What should the firm do to initiate a recall? (Firm-initiated recall)

The following information must be provided to the FDA for recall notification:
[21 CFR 7.46(a)]

1. Identify the product involved.

2. Give reason for the removal or correction. State the date and circumstance in which the hazard or product deficiency is discovered.

3. Evaluation of the risk associated with the hazard or deficiency.

4. Total amount of such product being manufactured and/or the timespan of production.

5. Total amount of product being distributed

6. Distribution information which include number of direct accounts and the identity of accounts, if necessary.

7. A copy of the firm’s recall communication if any has issued, or a proposed communication if it has yet issue.

8. Proposed recall strategy

9. Name and telephone number of the firm official who should be contacted concerning the recall.


Food and Drugs Administration Department of Health and Human Services. (2007). Title 21-Food and Drugs Chapter 1. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=7.46. Accessed on: 5 April, 2008.

Hi Guys,

The post the 12 April 2008 is on the code of regulation from FDA . I have only did the summary for section 7.40. The rest of the sections i will try to post up asap. However, u all can also visit their website for more details.


Food and Drugs Administration Department of Health and Human Services. (2007). Title 21-Food and Drugs Chapter 1. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=7. Accessed on: 5 April, 2008.

Code of Federation Regulations
21 CFR 7.40-7.59

What is 21 CFR 7.40-7.59?

21 CFR 7.40-7.59 are guidelines to films in conducting recall, and also a platform for Food and Drugs Administrations (FDA) to classify, monitor and access the effectiveness of recalls.


Section 7.40- Recall policy

Recall is a method of removing and correcting products that has violated the laws of Food and Drugs Administrations (FDA). This help to ensure the public health and well-beings are being protected from products that may post a risk of injury, gross deception or defective.

Recall can be initiated voluntarily by the manufactures and distributors itself, or at the request of Food and Drugs Administrations.

Food and Drugs Administration Department of Health and Human Services. (2007). Title 21-Food and Drugs Chapter 1. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=7.40. Accessed on: 5 April, 2008.

How can bakery food safety be ensured for the consumer?

Common pathogens require these factors for growth, thus controlling these factors can decreases their growth or toxin production.

Ø Availability of Nutrients
Ø Favorable Temperature
Ø Moisture Contents
Ø Proper acid level (acidity)

In the case of baked products, the chief factor that determines the self-life and safety of the products is the moisture contents.

Available Nutrients:
Flour, eggs, milk, sugar, and some other bakery food ingredients are excellent nutrients for microorganisms. Since it is not possible to prepare a quality bakery product without the use of these ingredients, it is unrealistic to consider restricting nutrients as a method of ensuring food safety.

Proper Temperature:
Most microorganisms grow best at temperatures near body temperature; however, they can also grow and multiply at temperatures between 45°Fahrenheit (F) and 140°F. Government regulations require that food products capable of supporting microbial growth must be stored above 140°F or below 45°F to ensure safety. Ambient temperature distribution conditions for bakery foods provide suitable temperature ranges for rapid growth of common food pathogens. Thus, unless bakery products are shipped and stored refrigerated or frozen, temperature control is not a viable method for ensuring food safety.

Proper Level of Acidity:
Microorganisms will grow in a wide range of acidity (commonly measured as pH). As shown in Table II, most bakery products fall within this pH range. Changing the pH of many cake products is not possible without adversely affecting the color, flavor, or texture of the product. Government guidelines require the pH to be below 4.6 for the product to be considered safe. Since most bakery products (with the exception of such items as fruit fillings/toppings) have pH above 4.6, the use of acidity as a general method to ensure food safety is very limited.

TABLE II
pH growth ranges for micro-organisms compared to typical ranges for cakes

Table 1: Approximate pH Growth Ranges of Organisms

Micro-organisms Approximate pH Growth Ranges of Organisms
E. coli 4.4 to 9.0
Salmonella 4.5 to 8.0
Molds 2.0 to 11.0
Yeast 2.5 to 8.5


Table 2: Cakes pH range

Cakes Product pH Range
Chocolate Cake 7.5 to 8.0
Devil’s Food Cake 8.0 to 9.0
Yellow Layer Cake 6.7 to 7.5
Chocolate Buttercream Icing 6.3 to 7.0
Cheese Danish 5.3 to 5.8
Pound Cake 6.8 to 7.0


Moisture Control:
Thus, with the exception of acidic foods, only one mechanism for ensuring food safety is practical-restriction of available moisture.



Donald K. (1985). ENSURING FOOD SAFETY IN BAKERY PRODUCTS. Dubois Volume VII, Issue 9 I September, 1985. Available at: https://secure.aibonline.org/subscribers/techbulletins/v07iss09.txt. Accessed on: 31st March, 2008.