The legal framework for food contact materials

The Swedish Food Act was recently amended to include materials and products that come into contact with food products, in order to supplement existing EU law with national provisions to strengthen public control and enable sanctions against violations. In this article, Setterwalls’ Johan Reimer and Lovisa Dahl Nelson offers a brief overview of the legal framework for food contact materials, together with an insight into the possible implications of the new regulations.

As a part of the EU’s legal framework for safe food, rules governing the materials and products that come in contact with food, known as food contact materials, has been enacted. The term “food contact materials” covers a broad range of materials and products, including packaging, containers, kitchen equipment, cutlery and dishes. Food contact materials are defined as materials that are intended to be brought into contact with food, are already in contact with food or can reasonably be expected to be brought into contact with food under normal or foreseeable use. Such food contact products may be made from a variety of materials, including glass, metal, paper and plastics, but can also include adhesives, coatings and printing inks. However, materials or products that are supplied as antiques, or covering or coating materials that may be consumed together with the food product, are exempted from the rules.

Food contact materials are primarily governed by Regulation (EC) No 1935/2004 (the FCM Regulation), which provides a harmonised legal framework for food contact material products throughout the EU. The FCM Regulation is directly applicable in the member states, without the need for any form of transposing etc. In the absence of specific EU measures, member states may maintain or adopt their own national provisions on food contact materials in accordance with the FCM Regulation. National legislation is in place in the majority of member states, setting out individual rules on different materials and substances, which may differ from one Member State to another, as well as providing complementary rules on, for example, sanctions and violations of the applicable provisions.

Materials or products that have not yet come in to contact with food when released on the market must be labelled with the words “for food contact” or a specific indication on the intended use, such as coffee machine, wine bottle, or soup spoon. Alternatively, it could be labelled with the specific glass/fork symbol in Annex II to the FCM Regulation. No such labelling is necessary if it is obvious that the product is designed as a food contact material (for example, a fork), or if the product is sold with food as containers (for example, a take-away carton).

If labelling is needed so that a certain material or product can be used safely and appropriately, that labelling should include information to that effect. Any such labelling must be conspicuous, clearly legible and indelible, and in a language that is easily understood by consumers. Traceability of materials and articles must be ensured at all stages, including the labelling of the food contact materials, in order to facilitate for example, control, recall of defective products and consumer information. In addition, the FCM Regulation stipulates a requirement that the labelling, advertising and presentation of a material or article must not be misleading to consumers.

According to the Regulation, food contact materials must be manufactured in compliance with good manufacturing practice so that the materials and articles do not transfer their constituents to the food in quantities that could endanger human health or bring about an unacceptable change in the food’s composition, smell or taste. Good Manufacturing Practice (GMP) in relation to food contact materials is further specified in the Regulation (EC) no. 2023/2006. Thus, in practice, there is a legally stipulated obligation of self-inspection that is then controlled and supervised by the regulatory authority. The rules are applicable throughout the entire supply chain, including the manufacturing, processing and distribution of food contact materials.

In short, GMP requirements aim to ensure that all materials are managed in agreement with the rules and quality standards applicable for the specific material. This includes, for example, ensuring that production is consistent over time and verified regularly, that staff is trained for the tasks assigned, that hazard analyses are performed and that all of this is properly documented.

The legal requirements stipulated in the FCM Regulation are primarily directed at the producers and traders of food contact materials. Thus, it is primarily the responsibility of the manufacturer to ensure that food contact materials meet the legal requirements. However, there are some requirements that food operators themselves must meet. For example, food operators must ensure that food that comes into contact with food contact materials remains safe, and that no undesired migration of substances takes place. Further, food operators must ensure that the food contact material in question is suitable for the type of food with which it is to come into contact with, as well as other conditions, such as cooling and heating.

The FCM Regulation also authorises the Commission to adopt special measures and rules for the materials and products that are stipulated in Annex I to the Regulation. The special measures may be for example, special conditions of use, certain threshold values and standards of purity or special rules on the traceability or labelling of the product (cf. article 5 of the Food Contact Materials Regulation). As a result, the Commission has adopted special rules for e.g. active and intelligent materials (Regulation (EC) No. 450/2009), plastics (Regulation (EC) No. 10/2011), recycled plastic materials (Regulation (EC) No. 282/2008) and ceramics (directive 84/500/EEC as amended).

Active and intelligent food contact materials are also subject to additional rules in the FCM Regulation itself, as such products may in some cases (subject to applicable rules on, for example, food additives), cause changes in the characteristics of the food product. The additional measures include rules on misleading information about the condition of the food product etc. Further, no information given by the intelligent materials or articles regarding the condition of the food may be provided that could be misleading for consumers. A list of active and intelligent materials is evaluated and assessed by EFSA (European Food Safety Authority) before their inclusion into a positive list – only authorized and approved substances from the list are allowed to be used in active and intelligent materials.

As for the changes in the legal framework for food contact materials in Sweden, which came into effect in July 2021, the Swedish Food Act was amended though the explicit inclusion of food contact materials within the scope of the law (see section 3 a, Swedish Food Act). At the same time, a general ban on the introduction on the market of food contact materials that do not meet the requirements of the Regulation has been enacted. The Swedish Food Agency has also been given the authority to require that certain, or all, manufacturers of food contact materials must be registered with the regulatory authorities. The Food Agency has yet to adopt any such ordinances.

In addition, further rules on the official controls for food contact materials were introduced. The supervising authorities have the power to issue the injunctions needed which it deems necessary to be able to supervise the compliance with the rules, including the issuance of fines, as well as a general right to information from and access to the premises of food operators subject to official controls. Finally, the official controls have been changed to be under the responsibility of the municipalities (which, with some exceptions, are generally responsible for official controls of food operators). For the municipalities, this means a novel control area (although similar to those for food operators), and new control objects. To reduce the risk of differentiating interpretations of the rules on food contact materials or differentiating decisions from the municipalities, the Food Agency has advised the municipalities to await guidance on the matter, which is expected to be issued in 2024 at the latest.

The Setterwalls Life Science team has extensive experience in highly regulated areas, such as the one for food contact materials, and are happy to assist with any queries you may have.