Lactose (Monohydrate, Wasserburg), Suitability as

An die interessierte Partei / To whom it may concern
Dr. Stefan Dreiheller
Quality Unit / Regulatory Affairs
Date of issue: 15.04.2015
Page 1/1
Doc.-No. EIP-1030-E
Revision 2
Suitability as ingredient in food products
Meggle product:
Lactose Monohydrate Ph. Eur. / USP-NF / JP: CapsuLac® 60, FlowLac® 90, FlowLac® 100, GranuLac® 140,
GranuLac® 200, GranuLac® 230, GranuLac® 70, PrismaLac® 40, SacheLac® 80, SorboLac® 400, SpheroLac®
100, Tablettose® 100, Tablettose® 70, Tablettose® 80
Inhaler Grade Lactose Monohydrate USP-NF / Ph. Eur. / JP: InhaLac® 70, InhaLac® 120, InhaLac® 230,
InhaLac® 250, InhaLac® 400
The products are manufactured as excipients for pharmaceutical industry. It conforms to the relevant
monographs as mentioned above. The use for which other regulations are applicable underlies the
responsibility of the customer.
The product is the natural occurring sugar of milk (milk sugar). It is gained from whey via crystallization,
washing and refining.
The product is suitable for human consumption and conforms to the current EC and German food
For the sake of completeness: The product is regarded as food (dairy product or sugar) and does neither fall
under the Regulation (EC) No 1333/2008 regarding food additives nor the Regulation (EU) No 231/2012
regarding specifications of food additives.
Freundliche Grüße / Best regards
Dr. Stefan Dreiheller
Molkerei MEGGLE Wasserburg GmbH & Co. KG y Megglestr. 6‐12 y 83512 Wasserburg y Telefon +49 (0) 8071 73‐0 y Fax +49 (0) 8071 73‐444 [email protected] y www.meggle‐ y Geschäftsführung MEGGLE Wasserburg Verwaltungs GmbH vertreten durch: Drs. Sil H. van der Ploeg MBA (Vorsitzender), Josef Bock • Dr. Franz Mayer • Dr. Egmont G. Pfeifer Amtsgericht Traunstein HRA 7828 y USt‐IdNr.: DE813497582 y St‐Nr. 156/116/00116