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Food Packaging Equipment – FoodPack Company

Foreign Compliance Case Study, May 2017

(Company Name Changed to Protect Confidentiality)

BACKGROUND

FoodPack designs and manufactures a full line of food industry packaging and processing equipment for the 

meat, poultry, seafood, baking, pasta, and cheese segments. Its machines have standard options, but can also 

be customized, a key point with regard to compliance. It has roughly 48 employees, with international 

representing between 5 and 25% of total sales. Over the years, FoodPack has sold into 12-14 different 

countries.

EUROPEAN MARKET

FoodPack got its first CE Mark roughly 15 years ago for its flagship machine. It worked with a U.S. based testing 

and compliance company, which is also an approved CE Testing Laboratory and an EU Notified Body (an 

organization designated to certify compliance with European regulations). This testing and compliance company

helped with the certification process, the technical manual, emissions testing, and development of the risk 

assessment. FoodPack claims that it “lived off [that CE Mark] for years, and never had questions or issues...” 

Since 2002, FoodPack has also worked with a 2nd U.S. based company for testing and documentation to certify 

additional machines. Over the years, standards have changed – with risk assessment having become 

particularly complex and comprehensive. FoodPack hasn’t had to change its products as a consequence, but 

additional documentation for the risk assessment standard has been necessary. FoodPack has also employed a 

3rd testing company specifically for EMC/EMI testing.

Each EU country has specific “twists” on the European requirements. At one point, FoodPack had a distributor 

located in the Netherlands. The distributor adapted FoodPack’s CE marked machines as needed for specific

country or customer requirements. But since separating from that distributor, FoodPack primarily sells direct to 

food processors. Consequently, FoodPack is now responsible for compliance with country-specific 

requirements, because it is no longer “buffered” by the distributor. FoodPack’s strategy has been to focus on 

compliance with the Machinery Directive (which is probably the most important set of requirements for their 

equipment). 

Affixing the CE Mark declares conformity with all applicable directives and standards, including the EU 

Machinery Directive. And it is extremely challenging to understand and conform to all these requirements, and

adapt to the specific “twists” required by each EU country. Recently, FoodPack had an issue with a French 

customer, which illustrates these challenges. The customer wanted modifications to the safety guards on the 

machine, and suggested that it was a compliance requirement. FoodPack believed it was in compliance with the 

general Machinery Directive, and asked the customer and the French certification body to cite the relevant 

standards that required modification of the guards. The French certification body was assessing the machine’s 

conformity with 28 applicable directives and standards, and their team could not identify the specific standard 

that required changes to the guards. As a result, the modification became a customer request, and was paid for 

by the customer.
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OTHER MARKETS

In Canada, CSA (Canadian Standards Association) compliance has not been a major barrier for the company. 

In the past, FoodPack sold direct to end-users who would work with the company on compliance. The customer

might send an engineer to FoodPack and together they would make minor adjustments to the product to 

conform with regulations. Or, in the case of one specific Canadian customer, FoodPack sold machines that 

were compliant with US standards and the customer assumed responsibility for Canadian compliance. 

Alternatively, in some cases, FoodPack sold equipment that was compliant with generic CSA standards, and the 

customer was responsible for compliance after making any modifications.

More recently, FoodPack has experienced new compliance challenges related to Ontario, Canada’s PSR (PreStart Health and Safety Review regulation). Before a worker can operate new or modified machinery or 

equipment, an “employer is responsible for ensuring that a thorough report is prepared that shows that the 

equipment is safe. This PSR report is required to review all of the relevant regulations pertaining to that 

particular type of equipment.”1 PSR is the responsibility of the employer of the machine operator not the 

manufacturer of the machine. (For example, it is not illegal to sell a non-PSR-compliant machine but it is illegal 

for an employer to have a worker use a non-compliant machine.) However, in Ontario, PSR responsibility is 

being pushed upstream onto the manufacturer. For FoodPack, the PSR-related modifications have been

relatively minor (such as putting properly sized holes in the machine guard that are large enough for washing 

the machine, but not large enough for a hand to fit through it) and the company has not needed outside 

assistance with the regulation.

OTHER STANDARDS

In terms of sanitary design regulations for food equipment, FoodPack indicated that if the equipment meets US 

standards (i.e. is USDA “accepted”), it is usually compliant in other countries - or at least 99% of the way there. 

Occasionally customers will suggest sanitary design modifications, which FoodPack will consider adopting for its 

standard product.

Typically, FoodPack does not sell the food contact materials used with its equipment internationally (such as 

interleaving paper), because the shipping costs are too high to be competitive. But, when it does, the company’s 

suppliers are compliant with international standards. For example, FoodPack's paper mill that ships to the 

Middle East, is SQF Level 2 Certified (Safe Quality Food program recognized by the Global Food Safety 

Initiative or GFSI). It’s vendor that sells wax paper for interleaving into Canada, is BRC Global Standards 

certified (also recognized by the GFSI). And its supplier that sells plastic film is AIB Certified. (AIB is an 

accredited certification body for BRC and SQF 2000 with accreditation pending for FSSC 22000 or Food Safety 

System Certification.)

OTHER ADVICE

Overall, compliance is not too onerous for FoodPack at this stage. “Finding a good consultant and lab that has 

experience with all the different standards in different markets is key. If you have your own engineering 

department, take what you learn from consultants and bring it back to improve your product.”

Even if you are working with a consultant, they suggest to “learn as much as you can on your own about the 

regulatory requirements you are attempting to satisfy. The consultant may understand the standards, but they 

do not know your product as well as you do. Your ability to assist and interact with your consultant constructively 

can only help the process.”

 1 http://www.safeworkengineering.com/psr-process.htm