Health Scientific Committees Scientific Steering Committee (former MDSC) Outcome of discussions

Opinion on the safety of tallow derived from ruminant tissues - Background

On 8 September 1997, the MDSC/SSC adopted the following opinion on the security of tallow.

" Tallow is a raw material which is used in the food, feed, medicinal and non-food sector. In the light of actual scientific knowledge on BSE, the question is still open if Tallow could transfer the BSE agent to animals (via the feed-chain) or to man (via the food and non-food chain).

To reach a sufficient degree of security when using tallow, it is therefore necessary that either the material used for the production of Tallow is safe, i.e. not infectious, or that the production process used has shown to actual knowledge that the agent is neutralised.

Concerning the raw material it has to be accepted that, as long as no test is available which allows to diagnose non-clinical BSE cases (pre-mortem), the only way of determining that the basic raw material is safe if a procedure as described by the OIE in Chapter 3.2.13 of the OIE International Zoo-Sanitary Code on BSE, is applied.

In cases where the animal material comes from a country of low risk or from a country controlled by epidemiological surveillance, this raw material has to be classified to be suitable for human consumption. In order to minimise a possibly remaining risk of infectivity of the raw material those parts of the animals which are supposed to carry a high level of infectivity (= the Specified Risk Material SRM, as defined in the corresponding opinion) shall be excluded from the production of tallow.

A third safeguard is a transformation process. So far it was accepted that no infectivity could be found after exposing even infected material over 20 minutes to a temperature of 133°C at 3 bar or an equivalent method with demonstrated efficacy. However, during the International Meat and Bone Meal Conference held in Brussels on 1 and 2 July 1997, it was not excluded that under worst case conditions, traces of infectivity could remain. This implies that the only safeguard at present is the certified origin of the material from which the product is derived AND an appropriate production process following acknowledged production rules.

Keeping in mind the remaining scientific uncertainties the SSC therefore recommends that in all cases the process "133°C, 3 bar, 20 minutes or an equivalent method with demonstrated efficacy" is to be applied, and that an infectivity of the raw material must be reduced to the maximum possible by sourcing (geographical origin or certification of individual animals) and by avoiding the use of specified risk material."

This opinion is line with the opinion adopted on 9 April 1996 by the Scientific veterinary Committee (E.C., 1996), which states:

" (...) Data on tallow have been obtained as part of the study on rendering processes, and show no detectable BSE infectivity in material from all tested systems on bioassay in susceptible mice. New data on inactivation of scrapie agent, however, indicates that only one system evaluated (133°C at 3 bar for 20 minutes) resulted in a product (meat and bone meal) which had no detectable infectivity. Because the initial titre of the agent in the BSE experiment was lower than in the scrapie study, only this latter process can be considered as providing adequate guarantees for the production of tallow.

(...) The following processes are recognised as giving the best possible guarantees:

1. (...)

2.Tallow produced in a process which ensures that all material is subjected to 133°C for at least 20 minutes at 3 bar, followed by filtration to eliminate protein residues."

Since the MDSC/SSC meeting of 8 September 1997, during which opinions on Tallow were adopted, a number of industry associations and third countries submitted a number of comments and technical and scientific dossiers. The main comment is that imposing a process "133°C / 3 bars / 20 minutes" is not reasonable for tallow production. The final product seems to be of inferior quality (discolouring of the material, altering of the fatty acids content, altering of the structural properties of tallow). However, in a comment on the preliminary opinion on the safety of tallow, the Irish State Veterinary Office stated that even a heat treatment of up to 300°C would have no impact on tallow quality, if carried out under vacuum conditions. Normal industrial tallow production processes - even the ones using the lowest time/temperature combinations - and corresponding research have shown to result in a product which is free from detectable TSE infectivity (injection into the brain of mice), even if the source material was highly infective. The explanation of these results seems to lay in the fact that " because of the proteinaceous nature of the TSE agents they would tend to remain with the cellular residues of meat and bone meal during extraction process, rather than be extracted with the lipids of tallow." (WHO, 1995; WHO, 1996; WHO, 1997).

In addition the final results of the 1991-1997 Rendering study became available (MAFF, 1997). This study is often used as a justification for the preceding statement that tallow can be considered safe even if it is submitted to much less harsh conditions. It is also part of the scientific basis of Commission Decisions N° 94/382/CE (repealed) and 96/449/CE.

The thesis that tallow is a safe product is also supported in the Guidelines to minimise the transmission of spongiform encephalopathies in medicinal products issued in 1994 by the German Federal Health Authority (BGA, 1994), which classified tallow in the lowest risk class which includes also milk. Also for the US-FDA, tallow and other fats are considered as non infective (see also the Report of the International scientific conference on animal meal held in Brussels on 1 and 2 July 1997) (EC, 1997).

On the basis of what precedes, the MDSC/SSC decided during its meeting of 16 October 1997, to create a working group on the safety of tallow.

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