Food

A Survey of Milk in Dark Chocolate Products

From 2009-2013, approximately 11% of food allergen-related entries in the Reportable Food Registry (RFR) were attributed to undeclared allergens in chocolates and other confections (1).  In order to estimate the prevalence of undeclared milk allergen in confections, FDA conducted a limited survey of dark chocolate products for the presence of milk.  The products were purchased in the U.S. from September 2013 to September 2014.  Of the 94 dark chocolate products surveyed, six contained milk or milk-derived components in the ingredient list, while 88 products were not explicitly labeled as containing milk (did not have milk in the ingredient statement or in a “Contains” statement).  In addition to the 94 chocolate products described above, additional lots of four of the dark chocolate products were obtained and analyzed for milk.  All chocolate products were classified into one of five different major categories based on label statement [milk or milk-derived component listed as ingredient (Table 1), advisory statements related to milk (Tables 2-5), dairy-free or lactose-free statements alone (Table 6), vegan statement alone (Table 7), and no statement regarding milk (Table 8)].  Products in the advisory statement category were classified into four subcategories.  These subcategories included products with advisory statements alone (Table 2), may contain traces statements (Table 3), advisory + vegan statements (Table 4), and advisory + dairy-free or lactose-free statements (Table 5).  Tables 1-8 show the milk concentrations in each dark chocolate product as measured by one or two analytical methods.  Limitations of this survey are that only a limited number of dark chocolate products in the U.S. market were surveyed for milk, and that only one sample for most products was analyzed for milk.  Thus, this survey only provides a “snapshot” view regarding the presence of undeclared milk in dark chocolate products.  

Table 1.  Amount (parts per million - ppm) of Milk Detected in Individual Dark Chocolate Products with MILK (OR MILK-DERIVED COMPONENT) LISTED AS INGREDIENT
Chocolate IDLabel/Package StatementResults of Milk Screening AssayResults of Quantitative Analyses - ppm milk (Method 1)Results of Quantitative Analyses - ppm milk (Method 2)
C1Milk in ingredient listPositive1,600-a
C2Cream (milk) in ingredient listPositive240-
C3Milk in ingredient listPositive5,300-
C4Milk fat (milk) in ingredient listPositive>8,400b-
C5Milk fat (milk) and sodium caseinate (milk) in ingredient listPositive>74,000-
C6Milk fat (milk) in ingredient listPositive>9,000-
Table 2 – Amount (ppm) of Milk Detected in Individual Dark Chocolate Products with ADVISORY STATEMENTS ALONEc
Chocolate IDLabel/Package StatementResults of Milk Screening AssayResults of Quantitative Analyses - ppm milk (Method 1)Results of Quantitative Analyses - ppm milk (Method 2)
A1May contain milkPositive690d
310
370
-
A2May contain milkPositive560720
A3Processed in a plant that processes dairy; Processed on equipment previously used to process milk chocolatePositive>3,700
3,500
2,000
-
A4May contain dairyNegativeNDeND
A5Made on equipment shared with milkPositive170
170
430
-
A6Facility uses milkPositive3,800
1,700
2,000
-
A7-Lot AfProcessed in a facility that also processes dairyPositive580900
A7-Lot BMay contain milkPositive2,1002,100
A8Manufactured in a facility that uses milkPositive4052
A9Made on equipment shared with products containing milkPositive2,4002,300
A10May contain milkPositive3,400
4,300
1,500
-
A11May contain milkPositive3,900
3,500
1,400
-
A12-Lot AProcessed in a facility that also uses  milkNegativeNDND
A12-Lot BProcessed in a facility with milkNegativeNDND
A13Manufactured in a facility that also handles milkPositive2,1002,100
A14Facility uses milkPositive9101,400
A15Manufactured in a facility that handles milkPositive110450
A16Artisan crafted in traditional grinding mills that also make milk chocolatePositive200
460
450
-
A17May contain milkPositive>14,000
> 17,000
9,700
14,000
-
-
A18May contain milkPositive3,6008,600
A19Produced on equipment shared with milkPositive4,400
6,700
7,900
-
A20May contain milkNegativeND-
A21Manufactured on equipment that processes milkNegativeND-
A22May contain milkPositive1,300
720
1,800
-
A23Made on shared equipment with dairyNegativeNDND
A24Manufactured on equipment processes products containing  milk powderPositive2,000
920
1,900
-
A25Made on equipment that also processes dairyNegative--
A26Equipment is used to process milkPositive3329
A27Processed in a facility that processes dairyPositiveND16
A28Made in a facility that uses milkNegative--
A29Made in a facility that handles milkPositive8,300140
A30May contain milkPositive140
680
160
-
Table 3.  Amount (ppm) of Milk Detected in Individual Dark Chocolate Products with MAY CONTAIN TRACES STATEMENTS
Chocolate IDLabel/Package StatementResults of Milk Screening AssayResults of Quantitative Analyses - ppm milk (Method 1)Results of Quantitative Analyses - ppm milk (Method 2)
T1May contain traces of milkNegativeND-
T2May contain traces of milkPositive66 67 
T3May contain traces of milkPositive62 72 
T4May contain traces of milkNegativeND-
T5Possible traces: milkNegativeND-
T6May contain traces of dairyPositive870 1,500 
T7May contain trace allergens of dairyPositive>5,900 2,600 
T8May contain traces of organic milkNegative--
T9May contain traces of dairy due to shared equipmentPositive470 750 
T10May contain traces of milkPositive
T11May contain traces of milkNegativeNDND
T12May contain traces of dairyPositive82023
T13-Lot AMay contain traces of milkPositive160400
T13-Lot BMay contain traces of milkPositive150460
T13-Lot CMay contain traces of milkPositive440320
T14May contain traces of milkPositive8297
T15May contain traces of milkPositive9201,200
T16May contain traces of milkPositive40
22
130
-
T17May contain traces of milk proteinsPositive6,7002,400
T18Possible traces:  milkNegativeND-
Table 4.  Amount (ppm) of Milk Detected in Individual Dark Chocolate Products with ADVISORY + VEGAN STATEMENTS
Chocolate IDLabel/Package StatementResults of Milk Screening AssayResults of Quantitative Analyses - ppm milk (Method 1)Results of Quantitative Analyses - ppm milk (Method 2)
IC1Suitable for vegans; Made on shared equipment with products containing milkPositive1,400 
3,300 
7,000 
-
IC2Vegan; Shares equipment with dairyPositive150
110 
6,500 
-
IC3Vegan; Manufactured in a facility that handles milkPositive20 
IC4Vegan; Made on equipment that processes milkPositive690 620 
IC5Vegan; Made on equipment that also processes milkPositive2,900 
5,900 
3,900
-
IC6Vegan; Produced on equipment that also processes product containing milkPositive820 690 
IC7Vegan; Processed in a facility that also uses milkNegative--
IC8Vegan; Prepared in a facility that also processes milkPositive460 340 
Table 5.  Amount (ppm) of Milk Detected in Individual Dark Chocolate Products with ADVISORY + DAIRY-FREE OR LACTOSE-FREE STATEMENTSg
Chocolate IDLabel/Package StatementResults of Milk Screening AssayResults of Quantitative Analyses - ppm milk (Method 1)Results of Quantitative Analyses - ppm milk (Method 2)
IC9Dairy free; Made on shared equipment with dairyPositive>2,200 1,700 
IC10Lactose free; Made in a facility that handles milk productsNegative--
IC11Free of dairy; May contain traces of dairy from shared equipmentPositive140
580 
240 
300 
Table 6.  Amount (ppm) of Milk Detected in Individual Dark Chocolate Products with DAIRY-FREE OR LACTOSE-FREE STATEMENTS ALONE
Chocolate IDLabel/Package StatementResults of Milk Screening AssayResults of Quantitative Analyses - ppm milk (Method 1)Results of Quantitative Analyses - ppm milk (Method 2)
F1Dairy-freeNegativeND-
F2Dairy-freeNegative--
F3Free of dairyNegative--
F4No dairy; Made in a dedicated facility that is milk-free; VeganNegativeND-
F5-Lot ADairy-freeNegativeND-
F5-Lot BDairy-freeNegative--
F6Created in a dairy-free facility; Vegan; Allergy friendlyNegative--
F7Dairy-free; Made without casein; VeganNegativeNDND
F8Dairy-freeNegative--
F9 Manufactured in a dairy-free facility; Lactose-free; VeganNegative--
F10Dairy-free; Made in our allergen free chocolate factoryNegativeND-
F11Dairy-freePositive1,200 360 
F12Lactose-free; VeganPositive1,100 
1,900  
3,900 
-
F13Contains no dairyNegative--
Table 7.  Amount (ppm) of Milk Detected in Individual Dark Chocolate Products with VEGAN STATEMENT ALONE
Chocolate IDLabel/Package StatementResults of Milk Screening AssayResults of Quantitative Analyses - ppm milk (Method 1)Results of Quantitative Analyses - ppm milk (Method 2)
V1VeganNegative--
V2VeganNegativeND-
V3VeganNegativeND-
V4VeganPositive3,2001,100
Table 8.  Amount (ppm) of Milk Detected in Individual Dark Chocolate Products with NO STATEMENT REGARDING MILK
Chocolate IDLabel/Package StatementResults of Milk Screening AssayResults of Quantitative Analyses - ppm milk (Method 1)Results of Quantitative Analyses - ppm milk (Method 2)
NS1No statementNegativeND-
NS2No statementNegativeND-
NS3No statementPositive270440
NS4No statementNegativeND-
NS5No statementNegativeND-
NS6No statementNegative--
NS7No statementPositive500
660
670
-
NS8No statementNegative--
NS9No statementPositive603,400
NS10No statementNegative--
NS11No statementNegative--
NS12No statementPositive1,6001,800
  1. - indicates that the chocolate sample was not analyzed.
  2. The > sign indicates that the concentration was greater than the value indicated.  In these cases, the samples exceeded the limit of the individual analysis.  The limit depended on the recovery obtained during each analysis and the analytical range of the standard curve.   
  3. The “ADVISORY STATEMENT ALONE” subcategory (Table 2) refers to statements regarding the possible presence of milk, such as “may contain milk (or dairy)”, “made on equipment shared with milk,” “processed in a plant that processes dairy,” or “manufactured in a facility that uses milk.”
  4. Multiple values indicate that two or three independent analyses were conducted for verification purposes. The different analytical results are within the acceptable variability associated with the analytical methods. 
  5. ND indicates that milk was not detected. As indicated in note #1 below, a few randomly selected chocolate products that tested negative in the screening assay were tested with Method 1, Method 2, or both methods to verify that they were indeed negative.   
  6. Two or three lots of four different chocolate products (A7, A12, T13, F5) were analyzed for milk.
  7. Lactose-free chocolates are grouped with dairy-free products although the statement “lactose-free” does not necessarily indicate that the product is free from milk.  

Table 1-8 notes:

  1. All chocolate products were first screened for the presence of milk using the Neogen Veratox® for Total Milk ELISA (Lansing, MI) test. Chocolate samples testing positive (≥ 2.5 ppm) for milk with the qualitative method were evaluated further to quantify milk concentrations using the Neogen Veratox® for Total Milk ELISA test (Method 1) and the Morinaga (Morinaga Institute of Biological Sciences, Japan) Milk Protein (Casein) ELISA test (Method 2). Chocolate samples labeled as “contains milk” were analyzed for milk concentrations using only one of the ELISA kits (Method 1). A few randomly selected chocolate products that tested negative in the screening assay were tested with Method 1, Method 2, or both methods to verify that they were indeed negative. The limit of detection (LOD) for Method 1 is 2.5 ppm milk, while that for Method 2 is 0.92 ppm milk.
  2. ppm = parts per million (microgram/gram)

Reference:

  1. Fourth Annual Report of the Reportable Food Registry (RFR): Retrieved from www.fda.gov/downloads/Food/ComplianceEnforcement/RFR/UCM395684.pdf

Page Last Updated: 02/04/2016
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