2Probity Registration is founded by AAA Certification AB, Öbergs miljö & kvalitetskonsult AB, Enhagen Invest AB, SDG Invest AB, the two last being privately owned Swedish holding companies.
AAA Certification has 13 years of experience in certification. They have currently over 1700 clients in 13 countries and is accredited by SWEDAC, Swedish Board for Accreditation and Conformity Assessment, for a large number of standards.
Öbergs miljö & kvalitetskonsult AB have 17 years of experience with management systems linked to several ISO standards. The company have more than 400 clients. Since 2008 the company also works with ISO 21469, the standard for hygiene requirements for lubricants with incidental product contact.
Impartiality and independence are our basic values in all the founding companies, also forming the baseline in 2Probity Registration AB. Probity stands for the quality of having strong moral principles; honesty and decency.
Customer service and assessor
Customer service and assessor
Customer service and assessor
Toxiocologists and experts
About H1 and other incidental contact lubricants for the food industry
H1 lubricants, also known as incidental contact lubricants, are not expected to but may occasionally come into contact with food under normal use conditions. As per requirements established by the US Food and Drug Administration (FDA) H1 lubricants must comply with 21 Code of Federal Regulations (CFR) 178.3570 to be approved. This regulation establishes formulary requirements for greases and lubricants intended for use in food processing and handling applications where incidental contact may occur. The approval for H1 was introduced by the United States Department of Agriculture (USDA) and was until 1998 administered by them.
Certification is however not required, except in the US, some countries do not use third-party certifications, instead this is federally regulated. Although, with that stated, certification is generally recognized as a minimum requirement in the industry and therefore there is a need for recognized certification bodies. Up until 2008 the NSF had a monopoly on certifications since they had been appointed to take over the process by the USDA in 1999. In 2008 Ins Registration started in Europe and has since then been a recognized counterpart to the NSF, but this ended abruptly in the summer of 2019 when NSF acquired the UK-based organization.
Since it in Europe is stated in union legislation that it is unfair practise to leave an entire market to one supplier the demand for a new certification body is clear. 2Probity is a Sweden-based company owned partly by AAA Certification and partly by Öbergs miljö och kvalitetskonsult. They have together more than 2000 clients in 13 countries and over 30 years of experience in working with ISO-standards.
Composition of food grade lubricants
Food grade lubricating greases must meet food standards and should not generate harm in case of contact with foodstuffs. Therefore, the compositions for food grade lubricant formulations should be selected and compiled in accordance with stringent specifications.
The authorised substance list for food grade lubricants is annually established and regulated by the FDA through Title 21 of the CFR. As far as food grade lubricants are concerned, these substances are mainly listed in the 178.3570 paragraph of the 21 CFR and in the GRAS (Generally Recognized As Safe) List. Some of the most common ingredients in food grade lubricants are:
Base oils – both synthetic and petroleum-based
- White oils
- Polyalphaolefins (synthetic lubricant) or PAO
- Polyglycols (poly alkene glycols) or PAG
- Silicones (Dimethylpolysiloxane)
Thickeners mainly used for grease
- Complex soaps: Aluminium, Calcium, Calcium Sulfonate
- Metallic soaps: Calcium
- Non-soap thickeners: Silica, Clay, Polyurea, PTFE
- Mainly listed in the 178.3570 paragraph of the 21 CFR
Greases are lubricating oils that have a thickening agent added to the formulation. Aluminium complex is the most common H1 food-grade grease thickener since they can withstand high temperatures and are water resistant which are important properties for food processing applications.
Categorization and terminology
H1 is not the only incidental food contact lubricant and to clarify the terminology comes here a list of categories that will be open for approval and certification by 2Probity:
- H1 lubricants are food-grade lubricants used where there is a possibility of incidental food contact.
- H3 lubricants are soluble/edible oils used to prevent rust and to clean equipment such as hooks, knives, trolleys etc during storage. H3 must be cleaned off the equipment before use since it is not an incidental lubricant classification.
- 3H release agents are oils defined as food additives made from pharmaceutical-grade white oils and their maximum levels in food are defined in 21 CFR 172.
- HX-1 are approved ingredients for use in H1 lubricants.
- HT-1 are heat transfer fluids used where there is incidental food contact in areas where high temperatures are required.
- HTX-1 are approved ingredients for use in HT-1 heat transfer fluids.
The Hazard Analysis and Critical Control Point (HACCP) program was implemented by the USDA and can be used to evaluate each lubrication point where contamination might occur to ensure the safety of the food production. Many major food-producing companies are currently using the HACCP system, but they do not always recognize the risks of not including evaluation of lubrication points. Several lubricant suppliers offer assistance to companies in this procedure and can help set up and implement a HACCP plan including numbering systems or color coding’s to help match the correct lubricant with its application point.
ISO 21469 “Safety of machinery – Lubricants with incidental product contact – Hygiene requirements”
To ensure that the hygiene requirements for oil and lubricants with occasional contact with food or pharmaceuticals are met a recognized global standard, the ISO 21469, is used. ISO 21469 refers to the specification of regulations for the composition (21 CFR 178.3570), manufacture, handling and use of lubricants that may come into contact with foodstuffs. The standard covers the following topics;
- Hygiene requirements
- Correct product description and packaging
- Risk assessment in the whole production process
ISO 21469 is suitable for any organization that produces and/or uses lubricants that come into, (incidental) contact with food, feed, medicines or cosmetic products. To obtain ISO 21469 certification, producers must submit to thorough testing of lubricant formulation, toxicology and product use. Annual unannounced plant audits are also part of the certification process.
Certifying your organization in accordance with the ISO 21469 shows that the lubricant components have been assessed as food-safe, that the product and packaging descriptions are complete and correct and that a food-safe production is guaranteed.