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.
| 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 | - |
| 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 - |
| 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 |
- - indicates that the chocolate sample was not analyzed.
- 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.
- 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.”
- 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.
- 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.
- Two or three lots of four different chocolate products (A7, A12, T13, F5) were analyzed for milk.
- 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:
- 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.
- ppm = parts per million (microgram/gram)