Regulation (EC) 1935/2004 calls for specific measures to be implemented for different food contact material groups to assess their safe use. While for example, plastic materials do have harmonized EU-level legislation in place there are many other materials, such as paper and paperboard, metals, adhesives, and inks, that do not have specific measures in place and are referred to as “non-harmonized materials.” To learn more about the Non-Harmonized Regulations of Food Contact Materials in the European Union, stream our podcast now.
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Hello everyone. Welcome to our special podcast series about food contact materials and article regulations. My name is Emmi Heino, food contact supply chain specialist, and today I am with Gülcan Erkaya, food contact regulatory affairs expert.
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Thank you, Emmi. Hello everyone, my name is Gülcan.
As you may remember, we talked about European Union Food Contact Material regulations in our first podcast and mentioned that in the EU, all types of food contact materials and articles fall under Framework Regulation 1935/2004 and must comply with it. In addition, there are specific legislations, so-called “specific measures,” for materials such as virgin and recycled plastics and ceramics. But then, we have other materials that do not have specific measures in place, and for this reason we refer to these materials as “non-harmonized materials.” Under the group of non-harmonized materials, we have paper and paperboard, metals, adhesives, and inks, to mention a few.
Emmi, can you give us some insight on how we can assess the safety of these non-harmonized materials?
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The framework regulation specifies that when specific measures are not in place for a certain material type, national legislation in EU member states should be consulted.
In addition to national laws, there are guidelines from industry associations, recommendations, and/or scientific opinions available, but as laws and decrees are legally binding, they should always be considered the first point of reference. For example, resolutions from the Council of Europe, or CoE, are often referred to when it comes to non-harmonized materials, but we have to keep in mind (1) that these are not legally binding, and (2) that the member states of the CoE are not equal to those of the EU.
Of course, given a lack of national laws and decrees on a certain type of food contact material, or FCM, we may consult such non-legally binding references for risk assessment purposes, as they often do offer information on safety aspects and what might be accepted within the industry. Actions and final compliance based on non-legally binding documents may be scientifically justified, but in the end, there is no legal force behind them.
In the context of national laws, we often hear about so-called “mutual recognition.” Gülcan, perhaps you could explain what we mean by “mutual recognition?”
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Following the EU principle of “free movement of goods,” we can apply the “mutual recognition” principle when marketing products in several EU countries. Mutual recognition is applicable if compliance with laws in Member State A provides an equivalent or higher level of health protection as required by the laws of Member State B.
Since there can be different interpretations of what is the appropriate measure to ensure the highest level of safety, we advise being cautious when applying this principle and recommend a case-by-case evaluation.
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Thank you, Gülcan.
Can you give us an example of how to approach compliance work with non-harmonized materials, by using paper and board as an example?
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Sure. I want to remind everyone that all the food contact materials and articles should be in compliance with Regulations (EC) 1935/2004, which we know as the framework regulation, and (EC) 2023/2006, the Good Manufacturing Practice, or GMP regulation.
For paper and paperboard, we can refer to national laws: Germany, Italy, and the Netherlands have the most well-known legislations in place for paper and board and those are typically used as a basis for compliance. The German BfR Recommendation 36 and its parts on paper and paperboard are not legally binding, but they are recognized by industry and authorities. Given this, and the fact that the recommendations have a strong scientific background, they can be regarded as the de-facto regulation for paper and paperboard. The recommendations include a positive list, testing requirements for the final material, and specific provisions for recycled fibres.
The Dutch Warenwet in the Netherlands and the Ministerial Decree in Italy are other legislations that could be consulted. These are legally binding and have similar requirements to those in the BfR recommendation. The French DGCCRF has also issued a guidance document for paper and board, which is not legally binding, but well respected in France. This guidance considers all types of paper and board applications, including coated ones, and includes requirements for composition and testing by reference to other available legislation, such as BfR.
In addition to the BfR recommendations, industry strongly relies on guidance from associations operating within the paper industry.
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Thank you, Gülcan. And as we know, metal food contact material, or FCM regulations are not harmonized in the EU either. Gülcan, which national legislations are in place for metals and alloys?
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The Italian Ministerial Decree is known to have the most extensive regulations for metal materials, such as aluminium and stainless steel, for use in food contact. Therefore, it may be considered as the first point of reference when assessing the safety of metal FCMs.
Also, the Netherlands Warenwet has a section for metal FCMs, and the French DGCCRF has published a guidance for metal FCMs. The guideline prepared by the Council of Europe EDQM Resolution CM/Res(2013)9 on metals and alloys used in food contact materials and articles is often taken as a reference for testing of metals and alloys in the EU; it indicates release limits for metallic components and metals as contaminants. However, we must remember that it has no legal value.
On a related note: Emmi, the regulatory status of food contact inks has recently evolved in EU. Can you give us more insight on that, please?
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Until recently, the Swiss Ordinance for printing inks was considered the de-facto regulation on food contact inks in the EU even though Switzerland is not an EU country. Until 2021, the Swiss printing inks ordinance was one-of-a-kind and based on scientific data on the safety of ink components and migration limits. However, Germany has been working on an ordinance of their own to ensure safe use of printing inks on food contact materials in the EU. The German printing ink ordinance came into force on December 2021, with a phase-in period lasting until 2025 to 2026 which allows industry to adjust accordingly. The ordinance applies to both printing inks and varnishes and includes a positive list of authorized substances to be used in the manufacturing of the materials.
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Thank you, Emmi.
To sum up the discussion, there are food contact materials for which regulations are not harmonized in the European Union. In these cases, the use of these materials must comply with applicable national laws of the Member States. If there are no applicable laws, various guidance documents can be referred to. We gave only a few examples of this today—the best compliance strategy is to adopt a case-by-case approach, which assess the regulatory landscape according to the material type.
Keeping in mind that all food contact materials must also comply with the Good Manufacturing Practice, or GMP regulation, we invite you to learn more about GMP in a new episode of this podcast series, coming soon. Thank you for listening and see you next time!
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Thank you, bye.