Feed additives review: consultants help EFSA 'better understand where data gaps may lie'

The European Food Safety Authority (EFSA) said it has received a total of 396 dossiers in the feed additives reevaluation procedure, called for under Article 10.2 of Regulation (EC) No 1831/2003. 

Among these are technological additive dossiers including categories like emulsifiers, gelling agents, stabilizers, thickeners, binders, anticaking agents and acidity regulators.

And data sheets supplied by IRTA, a Catalonia based public research institute, allows EFSAs’ Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) “to better understand where data gaps may lie”​ when it comes to re-evaluating such technological feed additive files, a spokesperson for the EU risk assessor told us.

IRTA won a tender in 2013 to analyze the information provided by the applicants to EFSA in relation to identification, description, physico-chemical properties, purity, manufacturing processes, safety for target species, safety for consumer and users and the environment and efficacy of the technological feed additives.

EFSA also asked the research institute to see where the dossiers deviated from legislation and guidelines and to integrate all the information into summary data sheets (SDS).

Lack of data on identity, safety and efficacy of additives ​

The IRTA team said they identified gaps in the three main sections - identity, safety and efficacy – in all 17 dossiers they reviewed in 2014. 

Sixteen out of 17 products were already authorized as food additives. Some of them were intended to be used in more than one category of target animals. Five dossiers were for pets, four were for a target group of animals and ten were intended for all animal species, said IRTA.

And the Catalonia based examiners concluded: “Such gaps might delay the evaluation process preventing risk assessors to conclude on all aspects of the safety and efficacy of the additives.”​

In terms of the current status of the 17 dossiers IRTA examined last year, the EFSA spokesperson said the risk assessment process by the Feed unit has commenced on that batch. “The working group of the FEEDAP Panel decides on a case-by-case basis whether to ask the applicants for additional information or data to allow it to carry out the risk assessment. This has happened in all 17 dossiers to date,”​ he added.

IRTA is charged with the review of the remainder of the additional technological feed additive batches until 2017.

“The contractor plays no part in the risk assessment process. Its role is limited to providing a summary of information provided in the dossiers and to check whether the information provided is aligned with the requirements in the regulation. The actual risk assessment is done by the FEEDAP Panel,”​ said the EFSA spokesperson.

The IRTA report can be accessed here​.