Reporting requirements
Common interpretation NVWA and MVO regarding reporting requirements in relation to exceeding maximum residue levels in vegetable oils for food or feed application
March 2012
Reporting obligation in the General Food Law (GFL)
According to Article 19 and 20 of the General Food Law (EU Regulation No. 178/2002), food and feed business operators should report to the competent authorities in case they have placed a food or feed on the market that is unsafe. The GFL defines a food or feed as any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans or animals.
Reporting to the NVWA
The Dutch Food and Consumer Product Safety Authority (NVWA) considers a food or feed product unsafe if it is either harmful or unfit for human consumption (GFL article 14 and 15). Harmful products are products that pose an immediate or long-term health risk. Products unfit for consumption may be unacceptable for the consumer for reasons of contamination, whether by extraneous matter or otherwise, or through putrefaction, deterioration or decay. These products include those that are not harmful as such. Harmful products include e.g. products that contain restricted substances like contaminants above legal limits. Concerning pesticides, the NVWA considers a product harmful as both the legal limit (MRL) is exceeded as well as a risk exists of exceedance of the ARfD (Acute Reference Dose) at a certain consumption level.
A business operator must notify the NVWA of products in the market that do not meet the legal requirements (i.e. non compliance) once these are out of the control of the food or feed business operator. As long as the food or feed is still under the control of the food or feed business operator, the operator in question has no obligation to report to the VWA. Moreover, it is also allowed to commercialize harmful products without notifying the VWA as long the product is duly labelled that it cannot be used for feed / food without further processing.
Measurement uncertainty
A business operator must notify the NVWA in case a product intended for direct human or animal consumption that is not meeting the legal limits is put on the market. This means that all values exceeding the legal limits have to be reported irrespective of the measurement uncertainty. However, the NVWA will take into consideration a measurement uncertainty of 50% in judging the analytical data. For example, a pesticide with a MRL of 0,2 mg/kg is found at a level of 0,38 mg/kg in refined oil. In this case, the business operator has to report to the NVWA. However, the NVWA will take no legal action (i.e. the product is not taken of the market) since 50% of 0,38 mg/kg is 0,19 mg/kg, which is below the legal limit of 0,2 mg/kg. In general the operator should take the measurement of uncertainty (MU) into consideration during processing for removal. However, the critical limit is MRL (*TF), so the target should be: MRL (* TF) - MU.
Practical example: deltamethrin in sunflower seed:
- MRL for sunflower seed is 0,05 mg/kg
- MRL for sunflower oil is 0,125 mg/kg
- Target for removal is 0,083 mg/kg, however, up till 0,125 mg/kg can be released to the market. Remark: MU is calculated from the analytical results.
Figure: Diagrammatic illustration of the effect of measurement uncertainty and the limit
There is no requirement for handling product with a result in category (iii) separately, so, commingling with other products is allowed as long as the analytical results obtained from an accredited laboratory with an appropriate accreditation scope are below the specified MRL.
Allowance of processing to redeem compliance
On the basis of Article 20 of EU Regulation No. 882/2004 (on official controls for verification of compliance with feed and food law), it is allowed to treat or process to bring the feed or food into line with the requirements of Community law excluding deliberate dilution. This means that the NVWA allows the removal of pesticides and contaminants during the normal operation conditions of the refining processes (physical or chemical refining).
The NVWA also tolerates a certain dilution that takes place during normal operation conditions of a continuous process as this is part of the normal operation conditions and it is not happening with the intention to dilute an exceeding consigment.
Furthermore, the NVWA agrees mixing of small barges (e.g. 500 metric tons) into a big tank (e.g. 2500 metric ton) before the analytical results of the individual small barges are available. If it subsequently appears that some of the individual barges contained an undesirable substance above the accepted limit (i.e. above ARfD/ADI), and the value for this particular substance in the big tank did not exceed the accepted limit there is no infringement as the dilution did not happen intentionally. The NVWA permits further processing of the total lot as long as the level of the undesirable substance is brought below the legal limit(s) for the final product during the refining process.
On the other hand, the NVWA does not allow to deliberately mix foodstuffs which exceed maximum levels of contaminants in final products intended for delivery to the market (e.g. refined oils).
It is also forbidden to deliberately detoxify foodstuffs (like peanuts and coconuts) containing mycotoxins by chemical treatments. These provisions are laid down in Article 3 of EU Regulation No. 1881/2006 (setting maximum levels for certain contaminants in foodstuffs). Since no legal limits apply to crude peanut and coconut oil, it is permitted to remove e.g. mycotoxins and benz(a)pyrene during the normal operation conditions of the oil refining processes (physical or chemical refining) to such an extent that the legal limits for the final products are met.
This means:
- Commingling of products with different BaP/Mycotoxin levels in crude oil is allowed
- Commingling of products with BaP / Mycotoxin above specified limit and below specified limit with the purpose to meet the regulatory requirement is not allowed.
Maximum residue limits pesticides
EU Regulation No. 396/2005 sets maximum residue limits for primary products, like oilseeds. MRLs for pesticides in processed products, like crude oils (and refined oils), are not specifically set in EU legislation. According to Article 20 of Regulation No. 396/2005, maximum residue levels for pesticides in processed products have to be derived from the MRLs for raw agricultural products, taking into account the concentration caused by the drying process as well as the concentration or dilution caused by processing (transfer factor).
For oils, the transfer factor depends on the type of processing and the extent to which meal and crude oil, pick up a specific pesticide during the crush. This can be determined experimentally or can be established by taking into account the fat solubility of a certain pesticide and the oil content of the specific crop. Table 1 gives some transfer factors from seed to crude oil during solvent extraction to be applied for fat soluble pesticides.
Table 1*: Transfer factors for fat soluble to be applied for fat soluble pesticides
|
Oil seed or fruit
|
Average oil percentage
|
Transfer factor
|
|
Palm fruit
|
50-55
|
2
|
|
Coconut (as it is for fruit incl coconut water)
|
20
|
5
|
|
Palm kernel
|
45
|
2
|
|
Rapeseed
|
40-45
|
2,5
|
|
Sunflower seed
|
40-45
|
2,5
|
|
Soybean
|
19
|
5
|
*the content of this table will be updated as new information/data comes available
The pesticide database of the EC indicates which pesticides are fat soluble (by putting (F) behind the particular pesticide). It should be noted that this information only provides general guidance which cannot be regarded as conclusive for some particular pesticides, i.e. some pesticides that are not identified as fat soluble do behave as such. In-house data are decisive in such cases.
Appendix 1 gives some examples for applying transfer factors in industry practice.
Use of mineral oil - FDA/NSF H1/Codex approved mineral oil components
There is a temporary acceptance for the presence of mineral oil in oil products to be further processed. The following release for crude and refined oil products (with exemption of Crude/Refined Sunflower oil from Ukraine) can be applied when a food grade/FDA approved processing aid is involved, which is a parafine type, pure, with low viscosity, lowest ADI - 0,01 mg/kg bw:
- During intake control the total hydrocarbon levels specified in the code of working practice at Fediol will be respected. A higher level will trigger further investigation. When after investigation the above type of mineral oil is involved, then ii and iii will be respected.
- Feed application max 400 mg/kg
- Food application: crude oil will be refined, whereby the removal should be till below LOQ - which is in practice up till 100 mg/kg based on the experience of the mineral oil crisis, applicable for other oils then sunflower oil. The LOQ is depending on the laboratory statement. Variation is possible due to the fact that the method is developed for sunflower oil, however, not for the other vegetable oils. Therefore, it should be further developed for other vegetable oils as well.
Note: for crude and refined sunflower oil origin Ukraine the applicable regulation have to and will be respected. For this oil the level specified limit is max 50 mg/kg after deduction of measurement uncertainty (MU).
Appendix 1. Examples
1. Deltametrin, a fat soluble pesticide (that is hard to beremoved by refining)
Example of a pesticide, which concentrates in the oil phase, e.g. Deltamethrin.
MRL for Deltamethrin in sunflower seed is 0,05 mg/kg (http://ec.europa.eu/sanco_pesticides/public/index.cfm)
The EU database gives (F), which is confirmed by experimental data.
The fat content in sunflower seed is in the 40-45%.
This implicates:
- MRL for sunflower seed is 0,05 mg/kg
- MRL for crude oil (taking into account the transfer factor) is 0,125 mg/kg
- MRL for co-products were no concentration takes place, like refined oil is also 0,125 mg/kg
- MRL for meal is 0,05 mg/kg (related to the reliable analytical capabilities) In case the crude oil exceeds the MRL of 0,125 mg/kg, co-streams which are supplied to feed industry, and there were concentration takes place, won't be supplied to feed industry.
2. Metalaxyl, a non fat soluble
Example of a pesticide, which is not fat soluble. It can concentrate in the meal.
MRL for Metalaxyl in sunflower seed is 0,1 mg/kg (http://ec.europa.eu/sanco_pesticides/public/index.cfm)
The EU database gives no (F), which is confirmed by experimental data.
After extraction, metalaxyl is found in both streams produced (crude oil and meal).
This implicates:
- MRL for crude oil is 0,1 mg/kg
- MRL for co-products were no concentration takes place, like refined oil is 0,1 mg/kg
- MRL for meal can be higher then 0,1 mg/kg due to concentration (related to the reliable analytical capabilities) In case the crude oil exceeds the MRL of 0,1 mg/kg, co-streams which are supplied to feed industry, and there were concentration takes place, won't be supplied to feed industry.
3. A pesticide which is concentrating in e.g. tropical oil fatty acid distillate
This is for the situation that the fruit / seed is meeting the legal requirement. Here is described what the levels could be in the products made thereof.
When the crude is below the specified MRL, the following levels can be expected in the products made thereof based on the transfer factors mentioned above:
a. Tropical fruit is 0,05 mg/kg, 20% oil
b. Crude oil is 0,25 mg/kg, 5% fatty acids
c. Fatty acid distillate is 5 mg/kg
4. For the situation that two or more products are blended for meeting the appropriate nutritional composition (blending of products is often done for specific feed applications)
Example for Pirimiphos-methyl, a fat soluble pesticide, described is what the levels could be in the products made thereof.
MRL for Pirimiphos-methyl in oilseeds and oilfruits is 0,05 mg/kg (http://ec.europa.eu/sanco_pesticides/public/index.cfm)
Pirimiphos-methyl MRL rapeseed fatty acids (= acid oils) 0,125 mg/kg (C2)
Pirimiphos-methyl MRL tropical fatty acid distillate 5 mg/kg (C1)
Note for the blender: before blending the fatty acids should meet the applicable regulations for that particular fat.
For the evaluation of the applicable MRL of the blend (when companies are buying a blend)
E.g. 20% tropical fatty acid distillate (N1) – 80% rapeseed fatty acids (N2)
• MRL mixed product: 0,2*5 mg/kg + 0,8*0,125 = 1,1 mg/kg
MRLx = {(N1C1 + N2C2 + N3C3 + …)}