6 replies to this topic

[alyakbarbintang]

Dear Sir/Madam,

 

We're food packaging manufacturer and have been certified FSSC 22000.

Some of our raw materials (e.g. lacquer) were intentionally used Epoxidized Soybean Oil (ESBO) in their ingredients. Annex II of reg. UE 1169/11 actually indicates, among the allergenic substances, "soybean and soybean products, except refined soybean oil and fat". There was a supplier that stated it is an allergen, but the others are not.

 

Does Epoxidized Soybean Oil (ESBO) categorize as an allergen? Is an allergen test needed?

 

 

please share with us if you have suggestions or insights about this matter.

 

Thank you in advance.

[sanidadexterior]

Hello,

ESBO or epoxidized soybean oil, is used in food packaging primarily in two ways: as a plasticizer in the sealing gasket of metal lids on glass jars, or as an additive in PVC.

In the EU, it is regulated by Regulation (EU) 10/2011, which establishes a specific migration limit for ESBO of 60 mg/kg.

Since it is not a food component (ingredient, food additive, enzyme, or processing aid intentionally added), it should not be listed on food labels. Therefore, it will not appear on the list of ingredients, nor will the other components of plastic packaging (resins, colorants, stabilizers, etc.).

If you use ESBO in the manufacture of packaging intended for export to the EU, you must monitor, through migration tests, that the ESBO added to the packaging does not exceed the corresponding SML.

Best regards from Spain

[SQFconsultant]

Allergen - YES, as ESBO can migrate to the food. Testing is needed.

[sanidadexterior]

Hello, see here

 

https://www.siegwerk...ens_V3.2_EN.pdf

[G M]

Highly refined oils are generally recognized as not being allergenic and are typically exempt from allergen labeling for this reason despite their origin.

[Tony-C]

Hi alyakbarbintang,

 

I believe that you will find your answer here: Epoxidized soybean oil in MOCAs, allergen risk? The lawyer Dario Dongo answers

 

Conclusions:

In light of the above, the risk of allergenicity of the material under examination could be excluded in the hypothesis in which, regardless of the epoxidation treatment, the soybean oil has been refined in order to eliminate the protein residues.

It is suggested therefore to ask the supplier for a specific written guarantee, carry out an analysis before accepting the material and frame the (albeit probably remote) risk in the context of one's own self-control system.

 

Kind regards,

 

Tony

[sanidadexterior]

Hello

An operator wishing to market materials and articles intended to come into contact with food in the EU must comply with the specific European regulation, Regulation EC 1935/2004, which establishes labeling requirements and requires the material or article to be accompanied by a written Declaration of Conformity.

If the material or article is made of plastic, it must also comply with the specific regulation for this type of material (Regulation EU 10/2011), which includes an annex with the model Declaration of Conformity to be used. This Regulation establishes a specific migration limit for ESBO that is quite high (60 ppm), indicating that this component is not allergenic. Indications that a food contains or may contain allergens are regulated in the EU by the regulation governing food labeling, and must be clearly marked on the list of ingredients.

The components of a food's packaging are not ingredients of that food.

If a component of the packaging appears in the food, it is only the result of migration.

If a package complies with EC Regulation 1935/2004, it must comply with the Specific Migration Limits established by that Regulation. It is doubtful that an object or material intended to come into contact with food that complies with the applicable regulations, including the migration limits for ESBO, could endanger the health of a consumer allergic to soy.

If ESBO present in a package migrates to the food contained within that package up to the established limit of 60 ppm and is capable of producing an allergic reaction in a consumer, we are facing a real problem and the specific migration limit for ESBO should be immediately reviewed.

Regards