EU Legislation and Related Testing for Food Contact Materials

Food Contact Materials (FCMs) come into contact with food in various ways: as primary packaging materials (e.g. bottles, cans, boxes, bags, etc.), during the transportation (containers, bins), during the food processing, transformation and packaging (e.g. food machinery), not forgetting kitchenware and tableware.

In Europe, Regulation (EC) No 1935/2004 (framework regulation) establishes the general requirements for all FCMs to ensure a high level of food safety when placed on the European market. The framework regulation deals with relevant aspects related to FCMs safety, such as:

• Specific measures for groups of materials and articles
• National specific measures
• Role of the European Food Safety Authority
• General requirements for the authorisation of substances
• Application for authorisation of a new substance
• Competent authorities of Member States
• Labelling
• Declaration of compliance
• Traceability

Emblematic of the purpose of this regulation is its article 3:

“1. Materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could:

(a) endanger human health;
or
(b) bring about an unacceptable change in the composition of the food;
or

(c) bring about a deterioration in the organoleptic characteristics thereof.

2. The labelling, advertising and presentation of a material or article shall not mislead the consumers.”

Also important in this legislative framework is the link with the Regulation (EC) No 2023/2006, which lays down rules on good manufacturing practice (GMP) for FCMs.

More detailed rules to regulate particular materials and substances are in turn derived from this framework regulation to create EU-specific measures. There are also national rules of the individual member states which may cover specific materials. These legislative provisions also define criteria and methods for monitoring FCMs to protect the consumer.

The FCMs currently covered by specific measures at EU level are:

• Plastic Materials
• Active and Intelligent Materials
• Recycled Plastic Materials
• Ceramics
• Regenerated Cellulose Film

In this article we will focus on specific measurements concerning food contact plastics: Regulation (EU) No 10/2011 that lays down rules on composition of plastic materials and reports the list of substances that are permitted to produce materials and articles (i.e. Union positive list).

Moreover, the Regulation provides:

• Overall Migration Limits (OML) and Specific Migration Limits (SML)
• Detailed migration testing rules: migration is usually carries out using food simulants representative for the food categories with which the material is intended to come into contact and the contact with the analytical sample is done under standardised time/temperature conditions.
• Criteria for the expression of migration test results.
• Rules for assessing compliance with migration limits: article 18 states that “The results of specific migration testing obtained in food shall prevail over the results obtained in food simulant. The results of specific migration testing obtained in food simulant shall prevail over the results obtained by screening approaches”.

Neotron provides general compliance testing for food contact plastics with reference to Regulation (EC) No 1935/2004 article 3 and to Regulation (EU) No 10/2011 including the following tests:

Sensory testing (odor and taste)

According to specific standards:

• UNI EN 1230-1 / 1230-2: paper and cardboard, including coated and/or printed material.
• UNI 10192: packaging materials and finished packaging in general, including composite materials that use paper and cardboard coupled with other materials (plastic films and aluminium foil).
• ISO 13302: packaging materials, finished packaging and objects intended to come into contact with food.
• DIN 10955: finished packaging, packaging materials and objects intended to come into contact with food.
• UNI EN 1622: materials intended to come into contact with drinking water.

Basic migration testing:

• Overall migration testing (according to UNI EN 1186).
• Specific migration of elements listed in Annex II of Regulation (EU) 10/2011 by ICP/MS.
• Specific migration of primary aromatic amines (PAAs) by LC/MS.

When relevant, this general testing package can be combined with additional tests, such as:

• Specific migration tests of substances with specific migration limitations (SMLs), that should be reported in FCM Declaration of Compliance (FCM DoC).
• Basic or Extended screening analyses of non-intentionally added substances (NIAS screening).
• Specific migration tests of critical/emerging contaminants.
• Analysis of packaged food for the detection of critical/emerging migrants or contaminants (e.g. BPA, Styrene, MOSH/MOAH, Phthalates).

Neotron has a dedicated department dealing with defining and performing compliance tests for food contact materials. The analysed samples include all categories of materials which may interact with foodstuff, in particular flexible and rigid plastic materials, paper and paperboard, aluminium, metals and alloys. Applied methods comply with international regulations, moreover it is possible to create customized protocols based on use and test specifications. The participation in an international technical network gives us the possibility to constantly stay updated about the most recent technical developments.

To learn more about Neotron FCM testing or to book a service, please contact us.