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Studies concerning safety of the additive

Studies concerning the safety of use of the additive for consumers

Lactobacillus plantarum is a very common microorganism growing on a broad variety of plants in high quantities. It occurs as normal constituent of silage and the use of BIO-SIL® does not substantially increase their concentration compared to silage prepared without use of additive (Pahlow et al. 2003, Kung et al. 2003). No additional studies are necessary.


Studies concerning safety of use of the additive for users/workers


Effects on the respiratory system

Beside the low allergenic exposure the dust formation of BIO-SIL® is low too. To evaluate the potential risk of possible dust while application, the particle size was analyzed with laser light diffraction (ISO 13320:2009) (Particle size analysis). BIO-SIL® is a very coarse lyophilized bacterial preparation with a particle size (d50) of 69.02 to 159.85 pm. This physical state results in no aerosol with a mass median aerodynamic diameter of < 4 pm. It is not required to carry out an acute inhalation toxicity study with BIO-SIL®. Moreover, due to the high particle size and the low dust characteristics and absence of volatility, BIO-SIL® is assessed to have very low potential for human inhalation hazard during handling or application (Expert statement). For this reason it was renounced on inhalation tests in laboratory animals and respiratory system tests.


Effects on the eyes and skin

Since the beginning of industrial production and broad agricultural appliance (1998) not one single case was reported about allergic reactions or irritations of the skin or eyes of the customer. Principal constituents of BIO-SIL®-powder are the non toxic and harmless Lactobacillus plantarum-strains with QPS-status and lactose. In the history of more than 10 years agricultural application of the starter culture no case of indisposition or other health reactions of a user occurred. Therefore no animal tests for skin and eye irritation were performed.


Exposure assessment

The manufacture of BIO-SIL® takes place in a factory specialized to starter cultures on the basis of lactic acid bacteria for food industry. While the production process, contaminations with detrimental microorganisms are severely suppressed. Dusts were sucked off in all machines and equipments dealing with dry product. In the production area workers wear sterile protective clothing including dust mask. Up to now no single case of irritation of the respiratory tract or the skin or eyes was observed. The concentrates of Lactobacillus plantarum DSM 8862 and Lactobacillus plantarum DSM 8866 as well as the lactose used for blending the cell number of the final starter culture have a very low allergenic potential. A total amount of 100 g BIO-SIL® is filled in composite-bags and sealed under nitrogen­ atmosphere. After storage and distribution the bags are first opened by customer. Generally the manufacture of the operational solution happens by pouring the whole content of one bag in tap water and stirring. Normally 10 I to 100 I water were used for 100 t ensiling material. Up to 5 - 6 bags are sufficient to manufacture larger amounts of daily operational solutions. To conclude, the risk of exposure while handling with BIO-SIL® can be assessed as low.


Measures to control exposure

Inhalation of higher amounts of product dust which may happen due to incorrect handling might induce sensitization and, in case of sensitized individuals, result in allergic reactions. A limiting value with respect to exposure has not been defined. The product does not contain acute toxic components. Skin irritation is possible in case of prolonged contact and in the eyes irritation might occur at direct contact. Health defects are not known to have occurred at proper use of product.

Although risk is low, careful handling is recommended. Especially the formation of dust and aerosol as well as electric discharge should be avoided. For production personal, the hygienic measures usually applied in food industry have to be considered. For respiratory protection dust masks should be worn, for hand protection in case of continuous skin contact protective gloves should be used and for eye protection protective glasses are to wear. For agricultural use on the field no special requirements are necessary except careful handling.


Material safety data sheet

According to the rules of food and feed industry a Material Safety Data Sheet for BIO-SIL® is not necessary but deliverable on request (MSDS of BIO-SIL®).


Studies concerning safety of use of the additive for the environment

• Not required for silage inoculants on the basis of Lactobacillus plantarum.


The production of effluent from clamp or silo during ensiling with BIO-SIL® in comparison to untreated silage is not influenced, neither the quantity nor the composition of microorganisms and ingredients.


References

G. Pahlow, R.E. Muck, F. Driehus, S.J.W.H. Oude Elferink, 2003. Microbiology of ensiling, p. 32-93, In: D.R. Buxton, R.E. Muck, J.H. Harrison (eds.), Silage science and technology, Agronomy (Number 42), Madison, USA, ISBN: 0-89118-151-2

L Kung jr., M.R. Stokes, CJ. Lin, 2003. Silage additives, p. 305-360, In: D.R. Buxton, R.E.

Muck, J.H. Harrison (eds.), Silage science and technology, Agronomy (Number 42), Madison, USA, ISBN: 0-89118-151-2