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 ID Label/Package Statement Results of Milk Screening Assay Results of Quantitative Analyses - ppm milk (Method 1) Results of Quantitative Analyses - ppm milk (Method 2)
C1 Milk in ingredient list Positive 1,600 -a
C2 Cream (milk) in ingredient list Positive 240 -
C3 Milk in ingredient list Positive 5,300 -
C4 Milk fat (milk) in ingredient list Positive >8,400b -
C5 Milk fat (milk) and sodium caseinate (milk) in ingredient list Positive >74,000 -
C6 Milk fat (milk) in ingredient list Positive >9,000 -
Table 2 – Amount (ppm) of Milk Detected in Individual Dark Chocolate Products with ADVISORY STATEMENTS ALONEc
Chocolate ID Label/Package Statement Results of Milk Screening Assay Results of Quantitative Analyses - ppm milk (Method 1) Results of Quantitative Analyses - ppm milk (Method 2)
A1 May contain milk Positive 690d
310
370
-
A2 May contain milk Positive 560 720
A3 Processed in a plant that processes dairy; Processed on equipment previously used to process milk chocolate Positive >3,700
3,500
2,000
-
A4 May contain dairy Negative NDe ND
A5 Made on equipment shared with milk Positive 170
170
430
-
A6 Facility uses milk Positive 3,800
1,700
2,000
-
A7-Lot Af Processed in a facility that also processes dairy Positive 580 900
A7-Lot B May contain milk Positive 2,100 2,100
A8 Manufactured in a facility that uses milk Positive 40 52
A9 Made on equipment shared with products containing milk Positive 2,400 2,300
A10 May contain milk Positive 3,400
4,300
1,500
-
A11 May contain milk Positive 3,900
3,500
1,400
-
A12-Lot A Processed in a facility that also uses  milk Negative ND ND
A12-Lot B Processed in a facility with milk Negative ND ND
A13 Manufactured in a facility that also handles milk Positive 2,100 2,100
A14 Facility uses milk Positive 910 1,400
A15 Manufactured in a facility that handles milk Positive 110 450
A16 Artisan crafted in traditional grinding mills that also make milk chocolate Positive 200
460
450
-
A17 May contain milk Positive >14,000
> 17,000
9,700
14,000
-
-
A18 May contain milk Positive 3,600 8,600
A19 Produced on equipment shared with milk Positive 4,400
6,700
7,900
-
A20 May contain milk Negative ND -
A21 Manufactured on equipment that processes milk Negative ND -
A22 May contain milk Positive 1,300
720
1,800
-
A23 Made on shared equipment with dairy Negative ND ND
A24 Manufactured on equipment processes products containing  milk powder Positive 2,000
920
1,900
-
A25 Made on equipment that also processes dairy Negative - -
A26 Equipment is used to process milk Positive 33 29
A27 Processed in a facility that processes dairy Positive ND 16
A28 Made in a facility that uses milk Negative - -
A29 Made in a facility that handles milk Positive 8,300 140
A30 May contain milk Positive 140
680
160
-
Table 3.  Amount (ppm) of Milk Detected in Individual Dark Chocolate Products with MAY CONTAIN TRACES STATEMENTS
Chocolate ID Label/Package Statement Results of Milk Screening Assay Results of Quantitative Analyses - ppm milk (Method 1) Results of Quantitative Analyses - ppm milk (Method 2)
T1 May contain traces of milk Negative ND -
T2 May contain traces of milk Positive 66  67 
T3 May contain traces of milk Positive 62  72 
T4 May contain traces of milk Negative ND -
T5 Possible traces: milk Negative ND -
T6 May contain traces of dairy Positive 870  1,500 
T7 May contain trace allergens of dairy Positive >5,900  2,600 
T8 May contain traces of organic milk Negative - -
T9 May contain traces of dairy due to shared equipment Positive 470  750 
T10 May contain traces of milk Positive
T11 May contain traces of milk Negative ND ND
T12 May contain traces of dairy Positive 820 23
T13-Lot A May contain traces of milk Positive 160 400
T13-Lot B May contain traces of milk Positive 150 460
T13-Lot C May contain traces of milk Positive 440 320
T14 May contain traces of milk Positive 82 97
T15 May contain traces of milk Positive 920 1,200
T16 May contain traces of milk Positive 40
22
130
-
T17 May contain traces of milk proteins Positive 6,700 2,400
T18 Possible traces:  milk Negative ND -
Table 4.  Amount (ppm) of Milk Detected in Individual Dark Chocolate Products with ADVISORY + VEGAN STATEMENTS
Chocolate ID Label/Package Statement Results of Milk Screening Assay Results of Quantitative Analyses - ppm milk (Method 1) Results of Quantitative Analyses - ppm milk (Method 2)
IC1 Suitable for vegans; Made on shared equipment with products containing milk Positive 1,400 
3,300 
7,000 
-
IC2 Vegan; Shares equipment with dairy Positive 150
110 
6,500 
-
IC3 Vegan; Manufactured in a facility that handles milk Positive 20 
IC4 Vegan; Made on equipment that processes milk Positive 690  620 
IC5 Vegan; Made on equipment that also processes milk Positive 2,900 
5,900 
3,900
-
IC6 Vegan; Produced on equipment that also processes product containing milk Positive 820  690 
IC7 Vegan; Processed in a facility that also uses milk Negative - -
IC8 Vegan; Prepared in a facility that also processes milk Positive 460  340 
Table 5.  Amount (ppm) of Milk Detected in Individual Dark Chocolate Products with ADVISORY + DAIRY-FREE OR LACTOSE-FREE STATEMENTSg
Chocolate ID Label/Package Statement Results of Milk Screening Assay Results of Quantitative Analyses - ppm milk (Method 1) Results of Quantitative Analyses - ppm milk (Method 2)
IC9 Dairy free; Made on shared equipment with dairy Positive >2,200  1,700 
IC10 Lactose free; Made in a facility that handles milk products Negative - -
IC11 Free of dairy; May contain traces of dairy from shared equipment Positive 140
580 
240 
300 
Table 6.  Amount (ppm) of Milk Detected in Individual Dark Chocolate Products with DAIRY-FREE OR LACTOSE-FREE STATEMENTS ALONE
Chocolate ID Label/Package Statement Results of Milk Screening Assay Results of Quantitative Analyses - ppm milk (Method 1) Results of Quantitative Analyses - ppm milk (Method 2)
F1 Dairy-free Negative ND -
F2 Dairy-free Negative - -
F3 Free of dairy Negative - -
F4 No dairy; Made in a dedicated facility that is milk-free; Vegan Negative ND -
F5-Lot A Dairy-free Negative ND -
F5-Lot B Dairy-free Negative - -
F6 Created in a dairy-free facility; Vegan; Allergy friendly Negative - -
F7 Dairy-free; Made without casein; Vegan Negative ND ND
F8 Dairy-free Negative - -
F9  Manufactured in a dairy-free facility; Lactose-free; Vegan Negative - -
F10 Dairy-free; Made in our allergen free chocolate factory Negative ND -
F11 Dairy-free Positive 1,200  360 
F12 Lactose-free; Vegan Positive 1,100 
1,900  
3,900 
-
F13 Contains no dairy Negative - -
Table 7.  Amount (ppm) of Milk Detected in Individual Dark Chocolate Products with VEGAN STATEMENT ALONE
Chocolate ID Label/Package Statement Results of Milk Screening Assay Results of Quantitative Analyses - ppm milk (Method 1) Results of Quantitative Analyses - ppm milk (Method 2)
V1 Vegan Negative - -
V2 Vegan Negative ND -
V3 Vegan Negative ND -
V4 Vegan Positive 3,200 1,100
Table 8.  Amount (ppm) of Milk Detected in Individual Dark Chocolate Products with NO STATEMENT REGARDING MILK
Chocolate ID Label/Package Statement Results of Milk Screening Assay Results of Quantitative Analyses - ppm milk (Method 1) Results of Quantitative Analyses - ppm milk (Method 2)
NS1 No statement Negative ND -
NS2 No statement Negative ND -
NS3 No statement Positive 270 440
NS4 No statement Negative ND -
NS5 No statement Negative ND -
NS6 No statement Negative - -
NS7 No statement Positive 500
660
670
-
NS8 No statement Negative - -
NS9 No statement Positive 60 3,400
NS10 No statement Negative - -
NS11 No statement Negative - -
NS12 No statement Positive 1,600 1,800
  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

 

Page Last Updated: 10/04/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English