The subject of harmonizing and aligning standards specified for food processing equipment in the United States, with design criteria intended for European equipment, can be rather complex and abstract. We will describe the importance of such harmonization, current activities between 3-A Sanitary Standards Inc. and its European counterpart to support this effort, and the common mission in the future for both organizations.
First, a little background on both organizations may help illustrate some commonalties between 3-A SSI and the European Hygienic Engineering & Design Group (EHEDG). In addition, we will describe certain points of differentiation that reflect slightly different approaches to the qualification of food processing equipment to hygienic design criteria.
Standards for equipment design
3-A SSI has developed standards for the design of equipment and systems since the 1920s through the collaboration of regulatory sanitarians (USDA, FDA and state agencies), academics, processors and fabricators. In fact, the name ‘3-A’ is derived from the three original stakeholder associations involved in this effort. The modern counterparts of these associations are the members of today’s 3-A SSI.
3-A SSI maintains an inventory of 73 “baseline” 3-A Sanitary Standards for discrete types of equipment that are used in virtually all phases of production and processing. And there are 10 3-A Accepted Practices for the design of systems such as pasteurization, spray drying, plant air and air in product areas, cleaning systems and more. Over many decades, these documents have served as important benchmarks in the regulatory inspections of equipment and facilities by USDA and FDA. 3-A SSI offers the voluntary 3-A Symbol authorization program for fabricators to display the 3-A Symbol on equipment built in conformance to a 3-A Sanitary Standard and verified by a third party verification inspection.
Based in Frankfurt, Germany, EHEDG is a consortium of equipment manufacturers, food industries, research institutes, and public health authorities. EHEDG was founded in 1989 with the aim to promote hygiene during the processing and packing of food products. The principal goal of EHEDG is the promotion of safe food by improving hygienic engineering and design in all aspects of food manufacture.
Europe’s hygienic guidelines
EHEDG actively supports European legislation, which requires that handling, preparation processing and packaging of food is done hygienically using hygienic machinery and in hygienic premises (EC Directive 2006/42/EC for Machinery, EN 1672-2 and EN ISO 14159 Hygiene requirement). EHEDG has developed 47 guidelines (versus standards), primarily for open and closed processing systems, to help fulfill European legislation requirements. The group offers equipment certification by EHEDG-accredited test institutes and maintains a database of certified equipment on its website.
The market for hygienic food processing equipment is truly global. Manufacturers in Europe, United States or anywhere else desire common rules or requirements for equipment design. For perspective, the database of current 3-A Symbol holders shows licensees from 29 countries outside the United States.
When it comes to producing equipment to meet EHEDG guidelines or a 3-A Sanitary Standard, a large number of issues require objective and specific definition in establishing conformance or true certification, including:
Materials of Construction
- Stainless steel criteria
- Elastomers and plastics
Hygienic Design and Construction
- Stainless steel weldings
- Surface roughness
- Geometry: corners, slopes, no dead spaces
- Fittings & gaskets
- Lids, conveying belts
- Frame and supports
- Space between equipment and walls/floors
Working toward harmonization
This is where the work of harmonization between EHEDG and 3-A SSI yields immediate benefits. Both organizations exchange their draft guidelines and standards for expert review and comments before publication. Both have worked to develop a glossary showing the contents of all EHEDG guidelines cross-referenced with the applicable 3-A Sanitary Standards. The glossary is summarized in a matrix available for free download from EHEDG.
Since the glossary was created, 3-A SSI has also introduced ANSI/3-A 00-00-2014, 3-A Sanitary Standards for General “Requirements,” which establishes minimum sanitary (hygienic) requirements for design, materials, and fabrication/installation of equipment and systems. Based on decades of collaboration within 3-A SSI, this is a compendium of general requirements for hygienic equipment used in food processing. This standard is finding broad recognition and utility among processors of all types of foods, food ingredients, beverages, or other edible materials.
Under provisions of the Food Safety Modernization Act (FSMA), food handlers and processors are required to implement and maintain a written preventive controls plan. These regulatory requirements will continue to incentivize equipment suppliers to provide equipment/systems which make the identification/control of potential hazards to finished foods much more effective and economical for processors. This portends a positive future for voluntary programs such as 3-A Symbol authorization and EHEDG certificates
Looking ahead, EHEDG and 3-A SSI will continue to align their respective documents to the extent possible. The question of universal acceptance of a single organization’s criteria or even some level of reciprocal acceptance rests with policy makers. But the path toward mutual acceptance or recognition can only be possible through the type of open cooperation that is currently underway.