Most equipment used in the packaging industry is powered via electrical and mechanical devices from filling and sealing machines to palletizers and labeling equipment. In order to bring your product to market in Europe, it must meet CE Marking requirements.
Packaging Industry Equipment
Packaging industry equipment used in the EU does require CE marking.
In addition, if the equipment is intended for the UK market then it will need to be UKCA marked which is essentially similar to CE marking in terms of the conformity assessment procedure with differences on the Declaration of Conformity.
CE Marking is mandatory for nearly all packaging industry equipment, including:
- Molding equipment
- Filling machines
- Sealing machines
- Blister pack machines
- Food packaging machines
- Carton labeling machines
The CE Marking Process
Packaging industry equipment by its nature has powered moving parts, so the safety aspects are addressed by the Machinery Directive (2006/42/EC). EMC aspects are addressed by the EMC Directive (2014/30/EU) and substance restrictions by RoHS (2011/65/EU). Depending on the equipment size it may be exempted from the requirements of RoHS.
Is CE/UKCA Marking Mandatory?
In short yes, if the equipment falls within the scope of any one of several of the above directives and UKCA legislation.
Annex I of the Machinery Directive lists the Essential Health and Safety requirements (EHSRs) which need to be addressed in your equipment before it can be considered safe. They are laid out in six sections which cover general issues common to all products in scope.
If the machinery packages foodstuffs, cosmetics, or pharmaceuticals then within Annex I there are supplementary Essential Health and Safety Requirements to be complied with. In addition to the safety aspects in Annex I, the machinery must be designed so that there is no risk of infection, sickness, or contamination/spoilage of the product. This covers aspects of cleaning and disinfection processes.
If the machinery processes finished products, then normally the EHSRs in Annex I are adequate to address the safety aspects. As a manufacturer, you have to assess your equipment against these EHSRs to ensure that under all conditions of use the safety is maintained.
While its use is not compulsory, the harmonised standard BS EN ISO 12100:2010 Safety of machinery – General principles for design – Risk assessment and risk reduction provides fundamental guidance and an overall framework for designers making decisions during the development of machinery to enable them to design machines that are safe for their intended use.
Packaging equipment safety requirements are covered in Type C standards. The applicable main standard family is:
- EN 415-1:2014 Safety of packaging machines – Part 1: Terminology and classification of packaging machines and associated equipment
Other parts of this standard cover finishing machines:
- Form, Fill, and Seal machines
- Wrapping machines both for products and pallets
- Strapping machines
If robots are incorporated in the process there are safety requirements under EN ISO 10218 and its respective parts:
- EN ISO 10218-1:2011 Robots and robotic devices – Safety requirements for industrial robots – Part 1: Robots (ISO 10218-1:2011)
For an updated standards list please click here.
For the general EMC compliance requirements then the EN 61000-6-X family of standards should be used depending upon the environment you intend the equipment to be used in.
Choose Technology International for CE Marking
At Technology International, we can guide you through every step of CE Marking for packaging industry equipment. We’re familiar with the CE certification process, whether a system is mechanical, electrical, or a combination of both.
Our manufacturing industry experience gives us the expertise to:
- Determine which EU Directives apply to an item
- Select the correct conformity modules
- Assess design and build per standards
- Aid with testing and risk assessment
- Carry out the necessary product inspections
- Compile the required documents for the Technical File
Contact us for support from the beginning to the end of the CE Marking process. We can optimize the path to CE certification success, navigate decision trees, and analyze the range of options that work for your unique product.
We know your industry—from the most massive machines to the smallest components, we’re ready to assist with every step to obtain a CE Marking for your packaging industry equipment.