What does the new Bisphenol Regulation mean for the food industry and what transitional arrangements apply?
Bisphenol A (“BPA”) is a chemical commonly used in plastic food and drink packaging, such as food containers, lunch boxes, cans and reusable plastic bottles. When BPA is used in packaging, small amounts can leach into food. This may be harmful to health, since BPA is known for its hormone-disrupting properties, harmful effects on the immune system, and negative impact on fertility.
Since 20 January 2025, the use and presence of BPA in food packaging has been prohibited under Regulation 2024/3190 (the “Bisphenol Regulation”). In this blog, we will address the new BPA regulations, at both European and Dutch level. We will also deal with the transitional rules for the use of bisphenol in the light of the Bisphenol Regulation. We will then address other important points for attention in the production of food packaging. Finally, we will focus on the enforcement by the Netherlands Food and Consumer Product Safety Authority (NVWA).
The new BPA ban
In the past it scientific research suggested that exposure of the European population to BPA below a certain threshold was not harmful. Therefore, a specific migration limit (“SML”) was applied under Regulation 10/2011, for the amount of BPA that was allowed to end up in food. However, research by the European Food Safety Authority (EFSA) into the effects of BPA (publication date 19 April 2023) has shown that exposure to BPA is much more harmful than initially thought. The EFSA has therefore lowered the BPA threshold value by a factor of 20,000.
Following the EFSA study, the use of BPA in food packaging has been banned under the new Bisphenol Regulation. The presence of BPA residues in food packaging is also prohibited. The limit set out in Regulation 10/2011 has therefore been abolished.
Transitional arrangement
Due to the (now obsolete) scientific knowledge about the effects of BPA, companies and individuals in the EU have relied on the assumption that exposure to BPA (below the established threshold) was safe over the past decades. The substance has therefore been widely used for the production of food packaging.
To prevent companies from having to change their entire production process from one day to the next, the Bisphenol Regulation contains various transitional provisions. For instance, single-use food packaging that complies with the regulations that applied before the entry into force of the Bisphenol Regulation may be placed on the market until 20 July 2026. A longer transition period applies to single-use food packaging intended for the preservation of vegetables, fruit or fish. They may be placed on the market until 20 January 2028.
General regulations on chemical substances in food packaging
The use of chemical substances in food packaging other than BPA is also subject to regulations. Those regulations can be found in Regulation 1935/2004 on food contact materials (the “FCM Regulation”). The FCM Regulation sets the general requirement that food packaging must be manufactured according to good manufacturing practice. In addition, the FCM Regulation lists 17 categories of food packaging for which the European Commission may take special measures.
For several of these groups, such as recycled plastics and cellophane, he Commission has indeed taken action. For example, the printed side of cellophane (a transparent packaging material), may not come into contact with food under Directive 2007/42/EC. Another example is ceramics, which are subject to specific Directive 84/500/EC. This directive determines the amount of lead and cadmium that ceramic objects may emit.
The aforementioned European food packaging regulations have been implemented in the Netherlands through, among other things, the Warenwetbesluit verpakkingen en gebruiksartikelen (the “Commodities Act Decree”) and the Warenwetregeling verpakkingen en gebruiksartikelen (the “Commodities Act Regulation”). The Commodities Act Decree sets general packaging requirements, such as the requirement that packaging may not be manufactured in such a way as to pose a risk to public health. The Commodities Act Regulation includes detailed rules and technical specifications that implement the general framework of the Commodities Act Decree. It sets specific standards, for instance, for 12 groups of materials (such as paper and cardboard, plastics, and glass) regarding the quantities of a substance that they may emit. The Commodities Act Regulation also contains rules as to which raw and auxiliary materials may be used in production. For instance, a select group of raw materials may be used for the production of paper, such as waste paper and cardboard, or fresh cellulose-based fibre materials.
Other examples of regulations for specific packaging are theCommodities Act Decree on Prepackaged Products (drinks), theCommodities Act Regulation on Strength Requirements for Soft Drink Bottles, and theCommodities Act Decree on Prepackaging Quantities.
Supervision and enforcement by the NVWA
The NVWA supervises compliance with regulations regarding food packaging materials. If it becomes apparent that food packaging materials do not meet the statutory requirements, the NVWA may take various enforcement measures, such as issuing official warnings and imposing fines. Under the Commodities Act, the administrative fine for breach of the packaging regulations may vary from €525 to 1% of the annual turnover of the company involved.
The NVWA may also impose corrective intervention measures, such as an obligation to modify packaging and/or remove a product from the market. If the company in question fails to comply with the measure, the NVWA may enforce it by imposing an order subject to a penalty, or carry out the imposed actions at the company's expense (administrative enforcement order).
It is therefore important for companies that use BPA in the production of food packaging to be and remain up to date with the applicable laws and regulations, in order to avoid fines and other enforcement measures.
For more information on inspections by the NVWA, watch this video briefing with practical tips or see invalnvwa.nl.
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