In Europe, food contact materials and articles fall under Regulation (EC) 1935/2004. This regulation applies to all types of materials and articles, including active and intelligent materials and articles that are intended to be brought into contact with food. It also applies to those that are already in contact with food and were intended for that purpose.
To learn more about Food Contact Materials and Articles Regulations in European Union, stream our podcast now.
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Hello, everyone! Welcome to the Assurance in Action podcast. Welcome to our first episode in our special podcast series about food contact materials and articles regulations in the European Union.
My name is My name is Gülcan Erkaya, Food Contact Regulatory Affairs Expert, and today I am with Emmi Heino, Food Contact Supply Chain Specialist.
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Thank you, Gülcan, for the introduction.
In Europe, food contact materials and articles fall under Regulation (EC) 1935/2004, which is known as a framework regulation. This regulation applies to all types of materials and articles, including active and intelligent materials and articles that are intended to be brought into contact with food. It also applies to those that are already in contact with food and were intended for that purpose. Following a risk-based thinking the regulation also applies to materials and articles that can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use.
It is important to note that this regulation does not apply to materials and articles that are supplied as antiques; covering or coating materials (such as the materials covering cheese rinds, prepared meat products or fruits) that form part of the food and may also be consumed with the food; or fixed public or private water supply equipment.
In this session we are going to explain the general requirements outlined in this regulation. Gülcan, do you want to start?
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As you know, according to Article 3 of the Regulation (EC) 1935/2004, food contact products must be safe to human health. The regulation requires that food contact materials and articles be manufactured in compliance with good manufacturing practice under normal or foreseeable conditions of use. The materials or articles must not transfer their constituents to food in quantities that could endanger human health; bring about an unacceptable change in the composition or in the organoleptic characteristics of the food. The regulation also indicates that the labelling, advertising, and presentation of a material or article shall not mislead the consumers.
The items I just mentioned are the key requirements of all food contact materials and articles, which is independent of their material composition.
What are the other requirements covered in the regulation though, Emmi?
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Thank you Gülcan!
The regulation also outlines general requirements for authorizations and approvals of new substances listed under the specific measures; rules for labelling and traceability of materials; as well as mandates for the specific measures required for a declaration of compliance. Furthermore, the annexes of the regulation include information on the food contact symbol to be used in the labelling of materials and articles, as well as the list of groups of materials and articles that may be covered by specific measures.
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Thank you, Emmi.
We know that specific measures, meaning material-specific regulations, exist for different material types (such as: plastics, recycled plastics, ceramics, regenerated cellulose, and active and intelligent materials). For example, in the case of plastics, we have to reference Commission Regulation (EU) 10/2011 and its requirements. Can you give us some more details about this legislation?
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There are specific measures for some of the materials that come into contact with food, and while, as you mentioned, the framework regulation applies to all types of materials, the specific measures are applicable only to specific material groups.
Commission Regulation (EU) 10/2011 is applicable to plastics and has extensive requirements for plastic materials and articles that come into contact with food. In terms of composition, it includes a positive list of authorized substances to be used in food contact materials and some rules for authorized but not listed substances.
In terms of compliance testing, this regulation requires food contact material manufacturers and suppliers to assess the overall migration of the material, as well as migration of certain substances, into the food. For the compliance testing, the substances in the composition of the material or article should first be authorized for use in accordance with the positive list or the other compositional rules. Next, the overall and specific migrations need to be tested to verify the safety of the material, using appropriate simulants and test conditions, depending on the type of foods and the use conditions of the material. Different simulants such as 10% ethanol (simulant A) for aqueous food, 3% acetic acid (simulant B) for acidic for fatty food are outlined in the legislation, the use of which should be chosen based on the food types in question. The conditions of the testing are to be chosen according to the contact time and temperature of the article.
The legislation also requires the food contact material or article to have a “Declaration of Compliance” before being placed on the market. Materials and articles covered by the specific measures should therefore be accompanied by a written declaration stating that they comply with the applicable rules. Each party involved in the manufacturing, converting, and distributing of the material is responsible for providing this written declaration to the next actor in the supply chain.
Gülcan, can you give some information regarding other EU level legislations in place, such as the one for ceramics?
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In Europe, Council Directive 84/500/EEC (amended by Commission Directive 2005/31/EC) provides the legislation for ceramic food contact articles. It generally includes the requirements for the quantities of lead and cadmium permitted to be transferred from ceramic articles, as well as migration limits, depending on the categories of products, and rules for testing. Ceramics also require a Declaration of Compliance, which is similar to plastics. So, if you have a ceramic article, you should comply with this regulation.
Maybe we can also talk about the compliance strategy for food contact materials and articles. What recommendations do you have for the industry?
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When it comes to compliance of food contact materials and articles, you want to start by requesting sufficient information from suppliers. Sufficient information would cover things like confirmation of compositional compliance, suitable end use conditions, testing, and so on, and all of this must adhere to the applicable regulations. As a final food contact material or article is often composed of several components, data are needed for each component.
After evaluating the supplier data, the required tests should be determined, planned, and performed accordingly. Following the testing, if compliance can be confirmed, a Declaration of Compliance should be prepared.
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What is your advice for food contact materials and articles that are found to be “noncompliant”?
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Non-compliance should always be handled on a case-by-case basis, depending on the reasoning behind non-compliance.
If compositional compliance cannot be confirmed, a discussion with your suppliers should take place to determine whether alternatives are available or perhaps other suppliers could be considered.
If you are a manufacturer of a food contact material and you have a non-listed substance in your formulation, it is possible to consider submitting a dossier to the authorities seeking inclusion of the substance into the positive list. This is a subject that would deserve a podcast of its own!
If your food contact material fails the testing, you can potentially go back to the manufacturing process and raw materials to do a root cause analysis to find out why the material did not withstand the test conditions chosen. Other actions may be relevant too.
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Thank you, Emmi, for this advice.
So, in summary, to bring a food contact material or article to market, the first step is to create a strategy, then take all the necessary actions to fulfill all regulatory requirements. It should be stated that it is quite easy to determine the requirements for food contact materials that have harmonized legislation in place. However—as we discussed earlier—there are many materials without specific EU level legislation. In those situations, besides being compliant with the framework regulation, you should follow the relevant national requirements or guidelines applicable to the material type if they exist.
How do we then build the compliance strategy for these types of materials? We invite you to learn more in a new episode of this podcast series, coming soon.
Thank you for listening and see you soon.
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Thank you, bye.