EFSA backs use of controversial binding agent in Europe

Thrombin is obtained from the blood of cattle and pigs, and is used with fibrinogen - a protein obtained from the same sources - to bind pieces of meat as well as fish, according to EFSA’s scientific opinion. The enzyme works by catalysing the transformation of fibrinogen to fibrin, which interacts with collagen to bind meat pieces. 

In 2010, the parliament voted, through a ‘comitology’ procedure for secondary legislation, to reject a European Commission amendment that would have listed thrombin as an approved ‘food additive’, which would have been subject to EU-level regulation. Member states have thus far been able to decide at national level whether to allow the use of thrombin as a food processing aid.

'Risk of misleading'​

At the time, a parliament resolution argued that thrombin, “​whilst derived from the edible parts of animals, has the character of a ‘meat-glue’ and its purpose as a food additive is to bind together separate meat pieces in order to produce a single meat product… and therefore the risk of misleading the consumer is obvious​”.

But EFSA’s panel on food contact materials, enzymes, flavourings and processing aids has now found thrombin to be safe because it comes from parts of the animals that are fit for human consumption if properly produced. ​

“Toxicological tests are not requested, as the thrombin and the concentrated plasma with fibrinogen are derived from edible parts of animals, namely blood plasma, which is intended to be or reasonably expected to be ingested by humans,”​ said EFSA in the document.

No safety concerns​

In addition, the panel noted that, considering the origin of thrombin, the likelihood of a food allergic reaction was low and raised no safety concerns.

This follows a 2014 application submitted by the Netherlands-based company Sonac for the authorisation of thrombin obtained from the blood plasma of cattle and pigs. The use of thrombin has already been approved in the Netherlands, the USA, Australia and New Zealand, said the EFSA document. 

The enzyme is made by collecting blood at the slaughterhouse after stunning the animals, adding citric acid to the blood to prevent coagulation, and storing the blood in cooled tanks until they reach the production plant. Thrombin is extracted from the blood plasma and stored below -18°C. The temperature in the storage room is continuously measured by an automated system with alarms. Every batch is microbiologically and biochemically tested before release.

'Technological need'​

“According to the applicant, there is a technological need to use thrombin in combination with fibrinogen-enriched plasma to form portion-controlled meat or fish parts,​ “This is a sustainable way to use meat and fish resources for human consumption.​” 

According to EFSA, the recommended maximum use levels of thrombin are up to 200 thrombin NIH (​National Institute of Health)units per kg food, corresponding to 1.95 mg TOS (total organic solids)/kg food.