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Dr. Tassilo Habereder; Eric Nehls

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1 Dr. Tassilo Habereder; Eric Nehls
PROTECTION Ciba Specialty Chemicals Additives for Food Grade Lubricants Dr. Tassilo Habereder; Eric Nehls Pictures: HygieniCon

2 Content Food Grade Lubricants’ requirements Base fluids
Classification Critical Control Points Base fluids Additives with FDA-approval Applications and Formulation recommendations

3 Picture:
Food grade lubricants Lubricants, which are needed by food, beverage and pharmaceutical producers have to meet special requirements: Technical requirements: national und international norms Specification from the end-user OEM specifications Hygienic requirements: lowest impact on living organisms no impact on taste or odor Legal requirements NSF positive list (former USDA) FDA approval (acc. to 21CFR ) ISO 21469: “Lubes with incidental product contact” Picture:

4  Positive List for „Food Grade“ additives
Legal requirements NSF = National Sanitation Foundation NSF started 1999 with the listing and registration for “Nonfood Compounds”. Providing a product approval process (Up-to-date, web-based listing) Classification for Lubricants and additives: H1 Lubricants with incidental contact H2 Lubricants with no contact H3 Soluble oils HX-1 Additives for H1 lubricants HX-2 Additives for H2 lubricants HX-3 Additives for H3 lubricants  Positive List for „Food Grade“ additives Link:

5 Food grade lubricants In the food producing industry generally 2 types of lubricants are used (as classified by National Sanitation Foundation (NSF) H1 - lubricants Food grade lubricant, containing only ingredients which are mentioned on an list of allowed substances issued by the Food and Drug Administration (FDA). The lubricant is suitable for an incidental, technically unavoidable contact with the food product. H2 - lubricants Food grade lubricant, which does not contain ingredients mentioned on a negative list issued from the USDA. Suitable for use in food an pharmaceutical industries provided that a contact with the food product is absolutely impossible

6 NSF Positive List for HX-1 Additives
Suitable additives can be selected. New or modified formulations have to be registered Registration of lubricant is simplified when only using NSF-listed additives. The maximum treat rate is noted. The trade name of the additives are noted. No technical guidance is given.

7 HACCP – Hazard analysis of critical control points
1. Does the process step include a hazard? Yes No No CCP 2. Does a control measurement exist? Yes No Modification of the process or product required Is a safety control necessary? Yes 3. Is a control necessary to avoid any hazard for the end user Yes CCP No No CCP

8 HACCP – Hazard Analysis of Critical Control Points
Typically the result of a HACCP is that a production site has critical control points and points where no further action would be required For critical processes, usage of H-1 lubricants is mandatory For non-critical processes, usage of H-2 lubricants is possible It has to be ensured that for critical processes a mix-up of H1 and H2 fluids is impossible

9 Base Fluids for food grade lubricants
White oil Toxicity is still not fully evaluated Different crude oil qualities can cause a different additive response No multi grade performance Weak low temperature performance Only available in viscosity grades ISO VG 15 und ISO VG 68 cheap Good additive solubility Polyalphaolefins Defined starting material (Decen) Well defined molecules Good performance High viscosity index Good low and high temperature Performance Available in different viscosity grades Expensive base fluid An increasing number of Esters und Polyglycols are FDA approved. It is expected to see a trend towards these base fluids in future.

10 Available FDA-approved additives
Examples for FDA-approved additives maximum allowed treat rate Antioxidants Liquid alkylated di-phenylamine (aminic antioxidant) 0.5 % Various high molecular weight phenolic antioxidants 0.5 % each High mol. weight phenolic antioxidant with thioether group Liquid di-alpha-tocopherol (Vitamine E) no limit (GRAS cleared) Blends of phenolic and aminic antioxidants 0.5 – 0.7 % Corrosion inhibitors/Metal Deactivators Liquid Imidazoline Derivative Liquid N-oleyl sarcosine Di-Sodium Sebacate (for greases) 2.0 % Liquid tolutriazole derivative 0.1 % Extreme Pressure / Antiwear Additives Liquid Amine phoshate Various Triphenyl Phophorothionates Liquid Di-N-Octyl Phophite EPA=environmental protection agency FDA=food and drug administration USDA=US depart. Of agriculture CDC=center for disease control and prevention PAHO=Pan American Health Organization WHO= World Health Organization

11 Applications Depending on the application and the specifications different fluids and formulations are necessary Hydraulic oils Gear oils Chain oils Compressor oils Oils for vacuum pumps Heat transfer fluids Greases Further differentiation possible via Kosher-grade Halal-grade

12 General formulation strategies
Selection of a suitable base fluid Think about mixtures such as PAO and Esters in order to benefit from the various advantages PAO and white oils can have limited additive solubility Carefully check the additive solubility in the selected base fluid The maximum treat rate of an additive is limited by the FDA approval sometimes additives with a similar profiles have to be used to achieve the performance while staying within the allowed limits Additives can have synergistic and antagonistic effects. Typically corrosion inhibitors and anti-wear additives have to be balanced. The formulation has to be checked carefully The final formulation has to be tested (lab scale and ideally in the field).

13 Starting formulation for greases:
Additive type treat rate Alkylated DPA AO 0.50 Phenolic AO with Thioether 0.40 0.20 Phenolic AO Tolutriazole derivative MD 0.10 Amine Phosphate AW Liquid TPPT Solid TPPT N-Oleyl Sarcosine CI Imidazoline Derivative Thickener System Thickener 2-20% Ester base fluid balance PAO or white oil Note: Amine Phosphates can react with soap thickener influencing the rheology. This has to be carefully checked.

14 Starting formulation for low temp. applications
Additive type treat rate Blend of ADPA and phenolic AO’s AO Tolutriazole Derivative MD 0.050 Amine Phosphate AW 0.100 N-Oleyl Sarcosine CI PAO or white oil base fluid balance Such a formulation would be suitable for circulating oils, providing a good metal protection and a good anti-wear performance The low treat rate of antioxidants and typically the use of a white oil as a base fluid would limit the use for high temperature applications

15 Ciba’ s food approved additives take care about your lubricant
PROTECTION Ciba Specialty Chemicals Ciba’ s food approved additives take care about your lubricant Picture: )

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