Good to know

1. GMO <0.9%

Products containing material which contains, consists of or is produced from GMOs in a proportion no higher than 0.9% of the food ingredients considered individually or food consisting of a single ingredient, provided that this presence is adventitious or technically unavoidable.


2. Difference between PCR (-ve)* and IP lecithin.

IMCOPA offers mainly certified IP lecithin. This means the product comes with fully documented traceability, i.e. it has been produced so that its origin can be traced back to its production source. PCR testing of representative samples at control points along the supply chain verify that systems and procedures are working properly to exclude GM contamination. “PCR (-ve)” means no GM DNA was detected at a specified level according to the methodology employed; it does not imply that the lecithin was produced from Non-GMO soybeans.


3. "Non-GMO" cannot be claimed for PCR (-ve) lecithin.

“PCR (-ve)” is simply the outcome of a test on a sample of lecithin and does not confer any Non-GMO status nor conventional origin on its own since the lecithin could be filtered, removing all traces of DNA. Furthermore, as a statement it may be false and therefore infringing on EU Regulation (EC) No. 1829/2003 – the so-called Labelling Regulation. And PCR (-ve) should be labelled as ‘This product contains genetically modified organisms’ or ‘This product contains genetically modified [name of organism(s)]’ appear on a label.


4. GMO >0.9%

Food and feed ingredients containing, consisting of, or produced from GMOs in proportion higher then 0.9% must carry a label which refers to the presence of GMOs (Regulation (EC) No 1830/2003).


5. PCR testing of lecithin with very low level of protein and DNA

The polymerase chain reaction (PCR) testing is used to identify lecithin derived from genetically modified organisms “GM” or “Non-GMO” sources. The principle of PCR method consists in creation of DNA replications from a single sample of DNA which are subsequently examined for the presence of transgenic DNA.

Since lecithin is a processed product which contains very low level of protein, only a small number of DNA copies are present in a tested sample. Therefore PCR testing of lecithin delivers rather reliable results on the presence of GM material in tested samples, but quantifying the presence of GMOs in lecithin can be extremely unreliable and consequently it is challenging to determine whether a GM label is required or not.


6. Lecithin as food additive E-322

Regulation (EC) No 1333/2008, contains purity criteria on food additives, among which on lecithin as E-322. E-322 is the E-number with which the European Food Safety Authority (‘EFSA’) has identified lecithin.
IMCOSOY®LEC complies with REGULATION (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives (including lecithin as E-322) listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council.

Lecithin is out of the scope of the Regulation (EC) 1881/2006 setting maximum levels for certain contaminants in foodstuffs and Regulation (EC) 396/2005 on pesticide MRLs. Beside this EU regulation No 1881/2006 mentions in Article 2.1b and 1c: “Dried, diluted, processed and compound foodstuffs”. When applying the maximum levels set out in the Annex to foodstuffs which are dried, diluted, processed or composed of more than one ingredient, the following shall be taken into account:
(b) changes of the concentration of the contaminant caused by processing
(c) the relative proportions of the ingredients in the product

Application in Feed as an ingredient or as an additive:
As ingredient soy lecithin is listed in the catalogue of feed materials (REGULATION (EU) No 575/2011).