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: www.kba-metronic.com
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
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