2 THE ULTIMATE LUBRICANTS AND ADDITIVES
USE OF LUBRICANTS IN THE FOOD INDUSTRY (Information sheet) INDEX - General information page 5 - Control: ASL and NAS in Italy page 5 - Contact with foodstuffs - Pharmacopea Specifications page 5 - Regulations according to FDA and USDA H1 page 5 - Regulations according to FDA and USDA H2 page 6 - NSF Regulations (National Sanitation Foundation USA) in force since January 2000 page 6 - Syneco Lubricants for Food Industry page 7 - Syneco CHECK-UP Service page 8 - Products SYNECO: - WF page 9 - Cleanair F page 10 - AIR 2000 page 11 - Vaseline Oil page 12 - WF Grease page 13 - NSF Certifications: - product AIR 2000 page 15 - product Cleanair1000 F page 16 - product Cleanair 680 F page 17 - product Cleanair 460 F page 18 - product Cleanair 320 F page 19 - product W.F. 150 page 20 - product W.F. 68 page 21 - product W.F. 46 page 22 - product W.F. 32 page 23 - product GREASE WF 2086/2 page 24 - product GREASE WF 2103/2 page 25 - product GREASE WF 2275 page 26 - Address NSF website page 27 3
4 THE ULTIMATE LUBRICANTS AND ADDITIVES
THE ULTIMATE LUBRICANTS AND ADDITIVES GENERAL INFORMATION SYNECO produces a series of lubricants destined to the use in the food industry, by means of not-toxic bases, particularly refined, of mineral and synthetic origin, combined with additivation packages free of heavy metals and such as not to interfere with the characteristics of the food or beverage. In case of applications of products with possible contact with foodstuffs the SYNECO formulations provide for: - the reduction to a minimum of the loss risk; - valid wear protection and reduction of the friction to the benefit of the lifetime and consumption of energy; - low working temperature and oxidation resistance with reduction of deposits on the lubricated surfaces. CONTROL: ASL-NAS in Italy. Verifications that have been made have a different purpose, according to the type of intervention: ASL: Local Health Authority examines the toxicological data sheets and verifies the use of the lubricants corresponding with the different applications of the company s production cycle. NAS: Anti-Adulteration Team (Carabinieri) makes verifications on the production cycle, so that there are no adulterations of foreign substances, among which the lubricant, that may accidentally come in contact with the food or beverage. Contact with foodstuffs - Pharmacopea Specifications. Products that can come in direct contact with the foodstuffs or used for medicinal or cosmetic purposes are covered by the Specifications of the Official Pharmacopea (F.U.) of the Italian Republic (Ministry of Health). For products that have F.U. pharmacological characteristics, the packaging is carried out at the manufacturer s. Regulations according to FDA and USDA H1. Lubricants do not usually come in contact with foodstuffs. However, during the production process there are situations in the Food and Pharmaceutical industry, in which it is technically impossible to avoid incidental contact of the lubricants with foodstuffs and drugs, or with containers and packages that at their turn come in contact with these products. Therefore solely USDA H1 classified lubricants must be used, that can not alter (taste, smell, color etc.) the foodstuffs, drugs and thus damage the 5
THE ULTIMATE LUBRICANTS AND ADDITIVES health of the consumer. The production and distribution of lubricants that may come in contact with foodstuffs must meet various regulations and provisions, that regulate their type-approval. The regulations being in force at present in Europe are waiting modification and the UE is preparing binding laws for the regulation of this situation and the consumer s safeguard. In the meantime, in the industrialized countries, and in particular in the EU-member States, usually the U.S.-regulations apply, that are well-known and applied all over the world. There are two institutions in the United States that enact the regulations and are able to establish the suitability of lubricants for use in the food industry: a) FDA (Food and Drug Administration, Food and drugs control body) is in charge of the preparation and updating of the so-called " positive list" (21 CFR 178 3570). This includes products that can be used for the production of lubricants that may come in contact with food. FDA does not issue authorizations or certifications neither for the products, nor for the relative manufacturers: the manufacturer and the good industrial practice are responsible for the suitability of the products and the expected relative application. b) USDA (United States Department of Agriculture, U.S. Ministry of Agriculture) has a wider field of action and responsibility: it is in charge of the verification, registration and control of : - products that are suitable for any contact with foodstuffs - manufacturers of these products, - food and pharmaceutical industry using these products and that are subject to the USDA regulations and control. USDA issues to those companies that meet the regulations, the authorization to use the USDA name and certification on packages and labels. Regulations according to FDA and USDA-H2. As USDA-H2 classified are lubricants that can be used in the food industry, with specific formulation and use of particularly selected bases and additives, for which there is no possibility of contact with foodstuffs or beverages (e.g. hydraulic circuits, grease for electric motors and diathermic oil for lyophilization plants, lubricant for OIL FREE compressors, overhead conveyor chains, reduction gears, refrigerator compressors, etc.). NSF Regulations (National Sanitation Foundation USA) in force since January 2000. 6 Until February 1998 for the Regulations 21 CFR 178 3570 lubricants with incidental contact with foodstuffs a letter of authorization and the use of the USDA logo for labeling of the usable product was issued by USDA (U.S. Department of Agriculture). At present FDA (Food and Drug Administration) does not issue any letter
THE ULTIMATE LUBRICANTS AND ADDITIVES of Conformity for the use of lubricants with incidental contact with foodstuffs. Since January 2000 a registration and control program has been implemented by NSF (National Sanitation Foundation USA) in compliance with the FDA regulations Code of Federal Regulations, Title 21-178, 3570, for verification of compliant formulation. SYNECO LUBRICANTS FOR FOOD INDUSTRY NSF-H1. Syneco SpA has included in its formulations a series of lubricant products being classified: "Lubricants with incidental contact with foodstuffs" with approval of FDA (Food and Drug Administration), Washington DC USA, currently NSF (National Sanitation Foundation USA) registration, in compliance with the FDA regulations, title 21 code of Federal Regulation paragraph 178,3570 Lubricants with Incidental Food Contact. In the preparation of lubricants for the food industry Syneco SpA uses raw material of non-toxic nature i.e. mineral and synthetic lubricant bases, submitted to particular processing and/or synthesis procedures together with additives that are free of heavy metals. The lubricants have particular functional characteristics, with the purpose to obtain valid performances during their use. Particular attention has been paid to: - increase of the lifetime of the lubricant or grease re-lubrication interval, with reduction of the standstill due to maintenance, - long lifetime of the components, including gaskets and relative compatibility with the used lubricant, - use in a quite wide temperature interval, - wear prevention during the start or running-in phases or in continuous operation, - corrosion prevention and condensate protection; - not staining for hands and work clothes; The examined formulations refer to the following products: - Syneco WF32, WF46, WF 68, WF150 - Syneco Cleanair 320 F, 460 F, 680 F, 1000 F - Syneco Air 2000 - Syneco Grease WF 2103/2 - Syneco Grease WF 2275 - Syneco Grease WF 2086/2 There are many machines/motors in the food industry with particular and severe operating and temperature conditions, under which there is no contact with foodstuffs and therefore no characteristic of contamination is requested and it is useful and possible to use traditional lubricants. 7
THE ULTIMATE LUBRICANTS AND ADDITIVES SYNECO CHECk-UP SEVICE. The performances of the Syneco lubricant in operation are followed by the Syneco Check-Up Service that performs a monitoring of the machine, by means of lubricant samples taken at subsequent intervals, measuring besides the product characteristics, the pollutant agents, metals from wear, water/condensate. It is thus possible to follow the behavior of the machine and its components in service upon contact with the lubricant, establish its lifetime in operation, establish according to the results, any possible or necessary preventive maintenance jobs, programming them according to the company s production cycle and in agreement with the machine manufacturer. CERTIFICATIONS. Syneco s quality system is in compliance with the requirements of the UNI EN ISO 9001/2000 Regulations issued by DNV-SINCERT on 1996-11-17 and UNI EN ISO 9002 quality for products according to the Official Pharmacopea specification of the Italian Republic. NSF International. NSF is an independent no-profit organization for the safeguard of the health of the users and the respect for the environment. Recognized at world level, NSF has taken the place of FDA (Food and Drugs Administration) and is now in charge of certification. For further and detailed information on NSF and to download the letters of approval of SYNECO products, please go to the NSF website at the following address: http://www.nsf.org/usda (hereinafter, at page 15 26, copy of the letters of certification of our products issued by NSF International) 8
THE ULTIMATE LUBRICANTS AND ADDITIVES SYNECO WF Series of non-toxic lubricant fluids. GENERALITY Clean and non-toxic products are important for food, pharmaceutical and beverage industries, water distribution and their packaging. In its formulations Syneco S.p.A. has a series of oil and grease lubricants for such applications and uses raw material of non-toxic nature, both lubricant bases submitted to particular refining or synthesis processes and, additives free of heavy metals. Every lubricant is formulated in order to obtain excellent performances, in particular: - increase of the oil change or grease re-lubrication interval; - long lifetime of the components, including gaskets; - reduction of the standstills due to maintenance; - use in a wide temperature interval; - wear prevention during the start or running-in phases; - corrosion prevention; - not staining for hands and work clothes; Furthermore there are many machines in the food industry with particular and severe operating and temperature conditions where there is no risk of contamination and so it is possible to use traditional lubricants, for example water-repellant greases operating at more than 180 C in bottle washing machines or in the chains of baking ovens, where a lubricant film protects the pins of the meshes in the oven feeding chains while at -20 C in the chains for cold or deep freezing rooms. PROPERTIES: The use of highly refined mineral and synthetic bases both in compliance with the American FDA standards (FOOD and DRUG ADMINISTRATION) make the Syneco WF series non-toxic, tasteless and odorless. The additivation package provides wearing, anti stick-slip, antioxidant, anti-foam characteristics and is free of heavy metals like Lead and Zinc. Excellent filterability levels and a good compatibility with metals, elastomers and paints. Also available in 55 liter-plastic package suitable for contact with foodstuffs. APPLICATIONS: Syneco WF32, WF 46 e WF 68 Hydraulic oils and lubrication oils in general for pumps, speed reduction units in casing. Syneco WF 150 Oils for reduction units, gearboxes for general lubrication of machinery, chains, with normal general lubrication or spray lubricator. CARATTERISTICHE: Syneco WF32 WF 46 WF 68 WF150 Color clear + + + + Specific weight at 15 C kg/l 0,848 0,850 0,855 0,858 Viscosity at 40 C ISO32 ISO 46 ISO68 ISO150 Viscosity index >130 >130 >130 >130 Pour point C -39 <-38 <-35 <-33 Toxicity: Absence of toxic substances + + + + Classification ISO 3498 L-HV L-HV L-CC Hydrolytic stability (ASTM D 2619) + + + + Filterability Denison (TP 02100) + + + + NSF: Registration e control / FDA 21CFR 178.3570 (The values above are referred to normal industrial production, they are indicative and subject to variation and improvement). 9
THE ULTIMATE LUBRICANTS AND ADDITIVES SYNECO CLEANAIR F Series of non-toxic lubricants for air compressors and vacuum pumps. PROPERTIES: The use of synthetic bases in compliance with the American FDA standards (FOOD and DRUG ADMINISTRATION) make the series of Syneco Cleanair F lubricants non-toxic, colorless, tasteless, odorless. The additivation package provides wearing, anti stick-slip, antioxidant, anti-foam characteristics and is free of heavy metals like Lead and Zinc. Excellent filterability levels and a good compatibility with metals, elastomers and paints. APPLICATIONS: Rotating screw and sliding vane compressors for air and vacuum pumps, where the lubricant may come in incidental contact with foodstuffs and/or beverages. CHARACTERISTICS: Type products CLEANAIR F: 320 460 680 1000 Viscosity ISO 32 46 68 100 Specific weight at 15 C kg/l 0,85 0,85 0,85 0,85 Viscosity at 100 C, cst 5,8 7,1 8,3 13,4 Viscosity index 125 130 134 136 Pour point, C less than... -40-40 -40-40 Flammability V.A., C 220 245 245 245 DIN 51352 - % viscosity increase about 40 C 2,1 2,8 2,7 2,4 - % Sludge weight 0,04 0,07 0,05 0,08 - TAN Increase 0,20 0,21 0,24 0,20 Viscosity at -28,9 C, c. Poise (c. P.) 3200 4700 6800 18000 Volatility Noack DIN 51581 % weight loss - at 200 C 1,5 1,1 1,0 1,0 - at 250 C 8,8 6,0 6,0 6,0 Oxidation Test - % Carb. after aging at 200 C POT DIN 51352-2 0,23 0,20 0,12 0,07 - % Carb. on 20% distillate DIN 51356 0,09 0,09 none none NSF: Registration control / FDA 21CFR 178.3570 (The values above are referred to normal industrial production, they are indicative and subject to variation and improvement). 10
THE ULTIMATE LUBRICANTS AND ADDITIVES SYNECO AIR 2000 Non-toxic multi-grade lubricant with synthetic base ISO VG 15 for atomizing in compressed air lines. PROPERTIES: The inherent characteristics of the product formulated with PAO base and proper additivation package guarantee: - easy to be atomized in compressed air, in a homogenous and gradual way under different room temperature conditions (multi-grade oil); - aptitude to absorb humidity in suspension in compressed air, thus avoiding a subsequent condensate deposit; - compatibility with different materials of the compressed air line; - high oxidation resistance, excellent adhesive and lubricant characteristics; - high wear and rust protection for the moving parts, also with long standstill periods, during the night or holidays. APPLICATIONS: Mist lubricators for tool feeding, beam motors, servo-mechanisms, valves, cylinders, assembly and packaging machine control, also in the food industry and in a chemical environment.o. ADVANTAGES: Absence of toxic products (PNA and aromatics) in the department; lifetime of the mechanical components. CHARACTERISTICS: SYNECO product AIR 2000 Color 0,5 Specific weight kg/l at 15 C. 0,880 Viscosity in cst at 40 C 15 16 Pour point. -40 C Flammability COC 220 C Use interval. -28 80 C Specification DIN 51502 DL 15 NSF: Registration control / FDA 21CFR 178.3570 (The values above are referred to normal industrial production, they are indicative and subject to variation and improvement). 11
THE ULTIMATE LUBRICANTS AND ADDITIVES SYNECO Vaselin Oil PROPERTIES AND APPROVALS: Safety in the application of lubricant in machinery of the food industry can be obtained with the use of medicinal-type liquid paraffin. Medicinal-type liquid paraffins are approved for direct contact with foodstuffs and used in the pharmaceutical, cosmetics and perfume industry. CHARACTERISTICS: Specific weight kg/l at 0 C. about 0,845 Viscosity in cst at 40 C ISO 15 (*) Pour point C -10 Colorless, odorless and tasteless characteristics; it meets the FU specifications (Official Pharmacopea specification of the Italian Republic) (*): other viscosities available upon request (The values above are referred to normal industrial production, they are indicative and subject to variation and improvement). 12
THE ULTIMATE LUBRICANTS AND ADDITIVES Greases for food purpose NSF SYNECO Grease WF 2086/2 USE: Grease for general applications, at the presence of humidity and water, in bearings, it provides a valid anti-oxidant and anti-corrosion additivation. CHARACTERISTICS: Thikening agent soap of anhydrous Calcium NLGI N 2 Drop point about 150 C Oil base ISO 68 Aspect white and slightly creamy (The values above are referred to normal industrial production, they are indicative and subject to variation and improvement). SYNECO Grease WF 2103/2 USE: EP grease with excellent resistance especially on bearings and plans. Antioxidant additives, anti-wear, anti-corrosion. CHARACTERISTICS Thikening agent soap of Aluminium complex NLGI N 2 Drop point about 270 C Oil base ISO 68 synthetic Aspect white and creamy (The values above are referred to normal industrial production, they are indicative and subject to variation and improvement). 13
THE ULTIMATE LUBRICANTS AND ADDITIVES Greases for food purpose NSF SYNECO Grease WF 2275 USE: Grease with anti-oxidant additivation with valid application at the presence of a high temperature and with no condensate. CHARACTERISTICS: Thikening agent infusible with PTFE, Zinc NLGI N 2 Pour point - Oil base ISO 68 synthetic Aspect clear grey (The values above are referred to normal industrial production, they are indicative and subject to variation and improvement). 14
SYNECO AIR 2000 Certification 15
16 SYNECO Cleanair 1000 F Certification
SYNECO Cleanair 680 F Certification 17
18 SYNECO Cleanair 460 F Certification
SYNECO Cleanair 320 F Certification 19
20 SYNECO W.F. 150 Certification
SYNECO W.F. 68 Certification 21
22 SYNECO W.F. 46 Certification
SYNECO W.F. 32 Certification 23
24 SYNECO GREASE WF 2086/2 Certification
SYNECO GREASE WF 2103/2 Certification 25
26 SYNECO GREASE WF 2275 Certification
CERTIFICATION SYNECO CAN BE CONSULTED BY ACCESSING THE WEB SITE OF THE NSF: http://www.nsf.org/usda List of products certified Syneco and obtained from the NSF website 27
CAT.ALIM (GB). - Rev.01 print 10-2013 cibs@snet.it THE ULTIMATE LUBRICANTS AND ADDITIVES SYNECO SpA 20098 SAN GIULIANO MILANESE (MI) - ITALY - Via Abruzzi, 10/12 tel: +39 02 9880840 r.a. - fax: +39 02 9880351 www.syneco.it - e mail: info@syneco.it