WHITE PAPER

FOOD CONTACT PROCESSING

EQUIPMENT AND APPLIANCES
COMPLIANCE WITH REGULATION (EU) NO 10/2011 FOR PLASTIC FOOD CONTACT MATERIALS

Author: Hilde Raemen, Application Specialist Food Contact, Intertek

FOOD CONTACT R
P OCESSING EQUIPMENT AND APLP IANCES

CONTENTS
FOOD CONTACT MATERIALS IN COMMERCIAL AND 3
DOMESTIC FOOD-PROCESSING EQUIPMENT
REGULATORY CONTEXT 3
CONSIDERATIONS FOR MIGRATION TESTING 4
STEPS TO MAINTAINING COMPLIANCE 6
CONCLUSION 6
REFERENCES 6
MEET OUR EXPERT 6

Food Contact materials (FCMs) are articles used in packaging, food storage, processing or preparation equipment that
come directly into contact with human foods. Foods can come into contact with these materials throughout the food
supply chain (processing, packaging, storage) and so it is important to understand the chemical composition of FCMs
and chemical composition and associated migration behaviour. In this white paper, our Application Specialist Food
Contact, Hilde Raemen, introduces food contact compliance for food processing equipment and appliances and how to
maintain compliance with Commission Regulation (EU) No 10/2011.

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FOOD CONTACT PROCESSING EQUIPMENT AND APPLIANCES

Food Contact Materials in Commercial And Domestic Food-Processing

Equipment
Commercial and domestic food-processing equipment can include plastic components to
support critical process steps such as processing, handling, conserving, packing and storing.
These components include hoses, tubes, mixing tools, storage tanks, pipes, filters, conveyor
belts and are made from common polymers, such as poly vinyl chloride (PVC), polyvinyl acetate
(PVA), polyethylene (PE), polypropylenes (PP), polyether ether ketone (PEEK), polycarbonates
(PC) which typically have inert high molecular weight structures. Using polymers in food
contact products instead of metal materials can enable improved resistance to heat, steam
and chemical cleaners whilst optimising the durability of the appliance when required to deal
with high process speeds, temperatures, volumes, pressures, and stresses.

In addition to the basic polymers, various additives are added to achieve specific desired
properties and/or simplify the manufacturing process. Fillers and softeners (plasticizers) might
be added in high concentrations to increase volume and/or weight and improve softening,
respectively. Other additives, such as heat and light stabilizers, antimicrobials, antioxidants,
colorants, UV absorbers, light screening pigments and dehydrating agents, are also used in
relatively small amounts.

Potential health risk may occur from non- or incompletely reacted monomers or other
starting substances or from low molecular weight additives which are transferred into food
via migration from the plastic food contact material. Therefore monomers, other starting
substances and additives should be risk assessed and authorised before their use in the
manufacture of plastic materials and articles used on food processing equipment.

Regulatory Context
Within the European Union, all materials and articles intended to come into contact with food
need to comply with the European Framework Regulation (EC) 1935/2004. This regulation
states that food contact materials may not threaten human health, or bring about changes
in smell, composition, colour or taste of the food. In addition, all food contact materials should
be manufactured according to Good Manufacturing Practice as regulated by Regulation (EC)
2023/2006.

The Commission Regulation (EU) No 10/2011 on plastic food contact materials and articles
establishes specific requirements for the manufacture and marketing of plastic materials
and articles1. The regulation sets out the rules on the composition of plastic food contact
materials (FCMs) and establishes a Union List of substances that are permitted for use in the
manufacture of plastic FCMs. The Regulation also specifies restrictions on the use of these
substances and sets out rules to determine the compliance of plastic materials and articles.

Several amendments to (EU) 10/2011 regulation have been released and implemented since
2011 and on the September 23 2020, Regulation (EU) 2020/12452 came into force. This
Regulation states that the compliance of the plastic material or article intended to come into
contact with food must be verified before it becomes incorporated into its final application as
part of a food processing equipment or an appliance and the latest amendment includes the
addition of testing rules that are specific to food processing equipment and appliances.

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FOOD CONTACT PROCESSING EQUIPMENT AND APPLIANCES

Considerations for Migration Testing

An important mechanism to ensure the safety of plastic materials is the use of migration
limits. There are 2 types of migration limits, the overall migration limit (OML) and the specific
migration limit (SML).

The Overall Migration Limit (OML) is a key consideration for assessing the compliance of
plastics materials and it refers the maximum permitted amount of non-volatile substances
released from a material or article into food simulants (Table 1 lists these simulants). The
overall migration limit is 10mg/dm² of the contact material or 60 mg/ kg food. The test
conditions for overall migration are set out in Chapter 3 of the Regulation and are described
here in Table 2. The food simulant shall be chosen in accordance with Annex III of the
Regulation. The overall migration tests should be carried out under the worst foreseeable
conditions of use (unless physical (or other changes) in the sample are observed).

Food simulant Abbreviation

Ethanol 10 % (v/v) Food simulant A
Acetic acid 3 % (w/v) Food simulant B
Ethanol 20 % (v/v) Food simulant C
Ethanol 50 % (v/v) Food simulant D1
Any vegetable oil containing less than 1 % unsaponifiable matter Food simulant D2
poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, Food simulant E
pore size 200 nm

Table 1 List of food simulants

As the industrial food processing and packaging industry often uses high-temperature
processes to achieve improvements in volume and speed, this increases technical
performance demands on the components and so to achieve optimisation of functional
performance and regulatory compliance, careful materials selection (e.g. high performance
thermoplastic materials required) and migration testing is required. This could well mean using
the high temperature applications test conditions such as OM7, OM8 or OM9.

In other food processing applications low temperature conditions are required in chilled or
refrigerated equipment or environments and so the low temperature test conditions of OM1
and OM0 may be required. OM0 is an additional new standard testing condition introduced
in the latest amendment to the Regulation (Regulation (EU) 2020/1245). This contact time
of 30 mins and contact temperature for testing 40°C is added for the intended food contact
conditions where materials and articles are in contact with food only at cold or ambient
temperatures for 30 minutes or less. Also, in this amendment to the overall migration testing
condition OM4, a reflux condition will be available as an option when testing at 100°C is
technically difficult [1 h at 100 °C or at reflux].

The Specific Migration Limit refers to the maximum permitted amount of a given substance
released from a material or article into food or food simulants. The specific migration limits are
included in the Union list. These are established by European Food Safety Authority (EFSA)
based on toxicity data of each specific substance.

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FOOD CONTACT PROCESSING EQUIPMENT AND APPLIANCES

When selecting test conditions, it is important to consider that in some appliances treating the appliance as a whole may not be appropriate.
Some components may have very different contact conditions (duration of contact, temperature), for example, those parts that are used for
storage, such as containers, reservoirs, or capsules. These will need to be tested separately to ensure they are also safe to be used for storage
conditions.

Test Contact time in days [d] or hours [h] at Intended food contact conditions
number Contact temperature in [°C] for testing
OM0 30 min at 40 °C Any food contact at cold or ambient temperatures and for a short duration (≤ 30
minutes).
OM1 10 d at 20 °C Any food contact at frozen and refrigerated conditions
OM2 2 10 d at 40 °C Any long-term storage at room temperature or below, including when packaged under
hot-fill conditions, and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for a
maximum of t = 120/2^((T-70)/10) minutes.
OM3 2 h at 70 °C Any food contact conditions that include hot-fill and/or heating up to a temperature T
where 70 °C ≤ T ≤ 100 °C for maximum of t = 120/ 2^((T-70)/10) minutes, which are
not followed by long-term room temperature or refrigerated storage.
OM4 1 h at 100 °C or at reflux High temperature applications for all types of food at temperature up to 100 °C.
OM5 2 h at 100 °C or at reflux or alternatively 1 h High temperature applications up to 121 °C.
at 121 °C
OM6 4 h at 100 °C or at reflux Any food contact conditions at a temperature exceeding 40 °C, and with foods for
which point 4 of Annex III assigns simulants A, B, C or D1.
OM7 2 h at 175 °C High temperature applications with fatty foods exceeding the conditions of OM5.
OM8 Food simulant E for 2 hours at 175 °C and High temperature applications only. Covers the intended food contact conditions
food simulant D2 for 2 hours at 100 °C described in OM1, OM3, OM4, OM5 and OM6
OM9 Food simulant E for 2 hours at 175 °C and High temperature applications including long term storage at room temperature.
food simulant D2 for 10 days at 40 °C Covers the intended food contact conditions described in OM1, OM2, OM3, OM4, OM5
and OM6
Table 2 Conditions for testing the overall migration

Food processing equipment often is built from multiple parts, these are made from plastic as well as other materials and this adds complexity
to the migration testing. In these cases, it could be possible to conduct migration tests (with food or simulant) using the entire appliance in
accordance with typical operating instructions, under the worst foreseeable use conditions, instead of trying to establish the migration from
each individual plastic component or material used.

If the transfer of substances from appliance as a whole does not exceed the migration limits, the plastic parts of the food processing
equipment should be considered to comply with the requirements of the Regulation as long as the plastic parts comply with the compositional
provisions of the Regulation (i.e. are the monomers and additives used listed in the Union list?).

In the case of non-compliance migration where testing on an entire appliance has been conducted, it would be critical to determine if the
source of non-compliance is a plastic part or another material not subject to the Regulation. The non-compliance of the equipment with the
Regulation should then only be established if that non-compliance is due to a plastic part.

The supporting documentation should clearly document the migration testing on the parts or on the whole food processing appliance. It should
clearly demonstrate that testing was representative of the conditions of use and detail all of the testing results. For manufacturers or suppliers
of a plastics food contact material (or additives) for a food appliance application, it is important to demonstrate compliance within a Declaration
of Compliance (DoC) for the product.

Challenging Conditions: Coffee Machines

High performance engineering plastics are necessary for use in contact with hot drinking water (or food). These applications are challenging
due to long term exposure to hot water, humidity at high temperature, and aggressive cleaners. Typical polymers include: PEEK, Sulfone
polymers and fluoropolymers.

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Steps to maintaining compliance for food processing equipment

manufacturers
1. As this Regulation has regular amendments, it is important to be aware of the latest
amendment in order to maintain compliance for your products. Practical steps which you
can take towards achieving compliance include:
2. Verify which regulations (in addition to the (EU) 1935/2004) are in place for your
products to fulfil compliance in global and/or local markets. For Europe, monitor the
European Commission legislation updates for Food Contact
3. Gather a complete list of all materials and substances used in the production of your food
contact material/product. Identify if the substances of your material may be used (check
positive list(s)) and/or if there are any limitations.
4. Identify the food contact application of your material (kind of foodstuff, time and
temperature conditions).
5. Conduct robust test programs either in house or via an expert 3rd party laboratory
including rigorous migration studies. Set up a compliance scheme for your product/
material. This may include migration tests, worst case calculation/modelling, screening
tests, NIAS studies/toxicological risk assessment.
6. Prove GMP compliance. Can your supplier demonstrate that the parts are manufactured
according to the guidelines of GMP?
7. Request the Declaration of Compliance (DoC) with EU 10/2011 from your supplier. The
DoC ensures the uninterrupted traceability of the plastic product, from the finished stock
shape all the way to the unique batch of raw materials for each For novel materials, set up
a declaration of compliance and make sure all supporting documentation is available on
request. If you do not have a regulatory function in house, work with an expert to ensure
that the DoC is accurate and contains all necessary information.
8. Set up a compliance management and supply chain management system to mitigate MEET OUR EXPERT
the impact of changes in the composition of your materials, processes, or changes in the
regulation towards the compliance of your FCM. Ensure there is good communication
across the supply chain. Hilde Raemen
Application Specialist Food
Contact
Conclusion
Plastic materials or components are increasingly used in food preparation appliances as Since 2010, Hilde has been
they offer the durability necessary to meet the demanding conditions of a food processing responsible for the technical and
application. These plastics materials and components are subject to regulatory expectations commercial implementation of
such as the Regulation EU 10/2011 and as the regulatory landscape is constantly evolving it customer’s food contact compliance
is important to ensure that materials and products remain compliant. The test conditions must programs in the role of Application
be carefully selected to ensure compliance, typically these represent the worst foreseeable Specialist Food Contact for Intertek
conditions of use. These migration test programs must be well documented in order to Polychemlab in Geleen, The
demonstrate compliance. Netherlands. Using her knowledge
about food contact regulations, her
focus is to support clients with the
References compliance program of
1. Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and their products.
articles intended to come into contact with food Text with EEA relevance.
2. Commission Regulation (EU) 2020/1245 of 2 September 2020 amending and correcting
Regulation (EU) No 10/2011 on plastic materials and articles intended to come into
contact with food.

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