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Standards and Regulations/Directives
Standards, Technical Reports, Regulations and Directives
Host Sean Riley sits down with Bruce Main, PMMI Machinery Safety Expert and Technical Advisor, to have a wide-ranging discussion about standards and regulations. During this conversation Main sought to clarify misconceptions about machinery standards, discuss PMMI’s latest standard update, and recommend a new white paper as a resource to OEMs. Main starts by clarifying the difference between legal regulations such as from OSHA or the EU, and voluntary industry standards like ANSI B155.1. Main emphasizes that the ANSI B155.1 is a standard that machinery builders and users need to pay attention to since it outlines the required risk assessment process. To round out the podcast, Main recommends the white paper 2023 The Impact of Global and Local Standards on OEMs & Suppliers to both OEMs and their customers to learn more about current standards and their subsequent impact. Listen by following the button below!
PMMI offers a hands-on workshop, Increase Your Business Value with Machine Safety Standards and Risk Assessment, that provides your team with risk assessment training and assists you in navigating the many areas of machinery safety standards and regulations. Gain knowledge on critical insights into machine safety, global standards, risk assessment essentials, and the EU Machinery Directive.
These workshops are highly encouraged for engineers, engineering teams and company leadership. This course provides an overview of regulations, norms, and standards in the major markets that produce and purchase packaging and processing machinery. Some have changed and can impact your machinery solution value; non-compliance can prevent you from capturing business in your target markets. Risk Assessment training is integrated as a core approach to improving value while addressing these regulatory and normative requirements.
The workshop addresses both U.S. and international material, including:
- The NEW ANSI/PMMI B155.1 – updates, changes and reasoning
- The NEW Machinery Regulation in the EU
- The NEW ISO 13849-1 and Functional safety basics
- The NEW robot standards ISO 10218
- Update on current machinery safety standards for packaging and processing applications
The requirements of this standard apply to new, modified or rebuilt industrial and commercial machinery which perform packaging functions for primary, secondary and tertiary packaging. Also included are: the conveying machinery used within the packaging functions; coordination of the packaging functions that take place in sequence on the production line; packaging related converting machinery. This standard does not apply to packaging machinery used by retail consumers.
The most recent update to this standard was released in July of 2023.
Purchase this standard from the ANSI online store.
ISO TC 313 Packaging machinery – Progress on this project continues to be difficult. There remain multiple disagreements among the participating country delegations. The drafting group continues working on the overall approach via online meetings only, which is limiting. Progress is being made, but slowly. PMMI participates in this international draft because of its potential impact to the industry. Due to the delay, the PMMI team is now focusing on the B155.1 update which can be used by all member companies.
ISO TC199 / Working Group 8 Functional Safety - The revision of ISO 13849-1 Safety of machinery – Safety-related parts of control systems – Part 1 General principles for Design is being prepared for publication. Procedural measures must still be completed; publication is expected by Q2-Q3 2023. PMMI is an active member of this work.
ISO TC199 / Working Group 5 Risk Assessment Updates - The work of WG5 to commence a technical revision of ISO 12100 Safety of machinery progresses well. An Amendment (limited revision) is anticipated, but a full revision may result given the proposed changes. This work will also attempt to align with requirements of the new draft Machinery Regulation. This work will likely continue into 2024. This standard impacts every packaging machine shipped to the EU. PMMI is in a lead position on this work.
ISO TC326 –Another U.S. association - ASABE - is seeking support for a U.S. Technical Advisory Group (TAG) and contacted PMMI. This support may involve requesting PMMI members’ input who are involved with feeding equipment for food of all types and possibly beverages. The Technical Services team continues to monitor is monitoring this activity to determine if/when direct involvement is warranted.
This document is divided into the Procedures for Development and Maintenance of Standards, as well as annexes which provide additional information about the development and processing of standards. These procedures were new in 2003 when PMMI changed from the “canvass” to “organization” method of standards development. The changes in this 2022 revision bring “PMMI’s Procedures” into compliance with the most current edition of the ANSI Essential Requirements: Due process requirements for American National Standards.
NEW! Introduction to Standards Development is a free program crafted by PMMI that is designed to benefit your business by providing insights related to standards participation. With knowledge of standards development, machinery can be designed, operated and maintained in accordance with applicable requirements. Also, machinery export business gains a tremendous benefit related to meeting requirements in effect at global destinations.
This program will increase your team's awareness of how standards can help your team meet its business objectives. In addition, the ability to participate in standards development supports a competitive solution for the global marketplace. The course is not industry-specific; it raises the importance and value of standards work within all industries. It features examples related directly to packaging and processing machinery.
In October of 2020, PMMI was awarded a Market Development Cooperator Program Award from the U.S. Department of Commerce. The partnership funding creates or sustains U.S. jobs by increasing or maintaining the export of American goods. With the financial and technical assistance provided by the International Trade Administration (ITA), PMMI developed this course to spread the education and awareness of standards.
To learn more and enroll in the course, head over to the PMMI Standards Training website.
ANSI B11.0 is very similar to ANSI/PMMI B155.1 in content, but it has a broader scope than packaging and processing machinery. Members who engage in business activities extending beyond packaging and processing should be certain to obtain the updated B11.0. Machinery suppliers, users, modifiers, purchasers of used machinery, and others can expect to be the main groups impacted by the clarified responsibilities listed in the text. The standard includes improved and updated text involving legacy machinery, remote/ tele- operations of machinery, and information for use manuals.
Click here to download the reference document relating to the development of ANSI B11-2020
Purchase this standard from the ANSI online store.
PMMI members may download a PDF copy of the complete EN-ISO-ANSI STANDARDS LIST.
This standard, MIL-STD-882E, replaces MIL-STD-882D and is approved for use by all Departments and Agencies within the U.S. Dept. of Defense (DOD).
This standard practice addresses an approach (a standard practice normally identified as system safety) useful in the management of environmental, safety, and health mishap risks encountered in the development, test, production, use, and disposal of DOD systems, subsystems, equipment, and facilities. The approach described herein conforms to the acquisition procedures in DOD Regulation 5000.2-R and provides a consistent means of evaluating identified mishap risks.
Take a listen to some of our technical standards associates as they share the importance of standards and the criticality of being involved in the standards development process!
Additional Resources
PMMI’s FSMA Consultant, Jeff Barach provides an in-depth overview including what steps packaging and processing equipment manufacturers should take to be proactive.
The 4th edition of PMMI’s Guide to the Key European Directives for Packaging Machinery is now available. If your company exports packaging machinery into the European Economic Area (EEA) the new PMMI guide is a must have resource. The sections of the new EU guide on RoHS, WEEE, REACH were reviewed by US legal council based in Brussels for content and accuracy.
Download the European Directives for updated information about:
- The Machinery Safety Directive
- The EMC directive – some packaging machinery installation may be exempt
- RoHS – what packaging machinery is exempt
- WEEE – how to comply
- REACH – what to do!
PMMI has made the following machinery directives for the EU available for download in Adobe PDF format.
PMMI’s Contact Task Force developed the PMMI Model Equipment Sales Agreement with input from the PMMI membership.
The Model Equipment Sales Agreement is designed to serve as a sample sales contract to assist members in identifying which contract terms are important in a sales agreement, and how those terms may be drafted. The terms of this Model Agreement have been selected based on several factors, including custom in the industry, clarity, and fairness.
While the Model Agreement may be utilized as written, PMMI members may also choose to select only certain specific provisions and incorporate these into contracts they have already developed. In this regard, also included is the document “Alternative Contract Clauses” which presents additional provisions that can be substituted for those in the Model Agreement. Of course, the negotiation process with customers may also result in different contract terms being used.
The Model Equipment Sales Agreement is intended to assist PMMI members. The decision to use the Model Agreement and its provisions, or any of the alternative clauses, is a voluntary business decision for each PMMI to make on its own and based on what is in the best interests of the member. PMMI does not require adherence.
PMMI intends to maintain the Model Agreement as a relevant and useful tool. Comments regarding the Model Agreement, including suggested modifications, are encouraged and should be submitted via e-mail to PMMI’s Director of Technical Services.
- Download the Model Sales Contract
- Download the Alternate Contract clauses
The Model Equipment Service Agreement, developed by PMMI's Service Contact Task Force, is designed to assist members in identifying which contract terms are important in a service agreement, and how those terms may be drafted. The provisions of this Model Agreement have been selected based on several factors, including customs in the industry, clarity, and fairness.
Also available is a set of Explanatory Notes which provide additional guidance and some alternative contract provisions.
- Download the Final Model Service Agreement
- Download the corresponding Explanatory Notes
While the Model Agreement may be utilized as written, PMMI members may also choose to select only certain specific provisions and incorporate these into contracts they have already developed. Of course, the decision to use the Model Agreement or any of its provisions, or to even offer a service agreement, is a voluntary, independent business decision for each PMMI member to make on its own and based on what is in the best interests of the member.
The RFID Experts Group (REG) was formed by the United States Dept. of Defense to speed implementation of Radio-frequency identification (RFID) and develop guidelines that could be incorporated into military standards.
However, since large retailers began utilizing RFID technology, REG sponsorship was transferred to AIM Global. Vist the AIM Global Web site to review the standards pertaining to this increasingly integral technology.
The REG subgroups have developed various guidelines, published as Terms of Reference (ToR). The leadership for ToR13, focused on packaging, is under PMMI.
ToR13, Proposed Guidelines for the Use of passive RFID Transponders on Transport units and Pallets for Commercial Uses, is available now for download and comment below.
ANSI Essential Requirements: Due process requirements for American National Standards is referenced in the PMMI Procedures for Development and Maintenance of Standards document and outlines the mandatory requirements, commercial terms and 4.2.1.3 Criteria for withdrawal.