Food-Contact Substances under the Spotlight in the European Union and the United States
The EU and the U.S. have traditionally taken a different approach to the regulation of food-contact materials and articles. Nonetheless, in both jurisdictions, there is an increasing focus on specific categories of substances due to potential effects on human health.
Starting with the most recent main developments in the U.S., we then briefly look at the current situation in the EU, including ongoing initiatives to tackle some food contact substances that are considered to be of actual or potential concern by the authorities or EU institutions.
In January 2016, the U.S. Food and Drug Administration (the FDA) amended the food additive regulations to delist three perfluoroalkyl ethyl containing food-contact substances (FCSs) as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods. The FDA made its decision based mainly on new data about the toxicity of substances structurally similar to the FCSs, as this new data led to the conclusion that there is no longer a reasonable certainty of no harm for the food contact use of these FCSs. In practice, industry had abandoned the use of these substances years ago.
In April 2016, the FDA also accepted for consideration a food additive petition calling for a revocation of the regulatory clearances for thirty ortho-phthalates when used as components of food-contact articles. The FDA is to complete its scientific review within 90 days of the filing date of the petition, but the time for the review may be extended by an additional 90 day period.
Following the FDA’s rejection of certain requests in the April 2016 food additive petition, a citizen petition was filed with the FDA later that same month to remove five ortho-phthalates from the list of prior-sanctioned substances[1] and to prohibit the use of eight other food-contact ortho-phthalates by issuing a new regulation.
Fluorinated Compounds and Phthalates
In the EU, fluorinated compounds, including perfluoroalkyl ethyl containing food-contact substances, are often used in the manufacture of food-contact materials, notably paper and board. Indeed, many fluorinated compounds are listed in Member State legislation and in the German Institute for Risk Assessment’s (BfR) paper and paperboard recommendations. It is noteworthy that the Danish Ministry of Environment and Food recommended a non-binding migration limit of 0.35 µg fluorine/dm2 for the total content of organic fluorine in paper. The Danish Ministry has indicated that although this limit is not legally binding, it will be taken into consideration when assessing whether food-contact paper complies with Article 3 of the EU’s Framework Regulation (EC) No. 1935/2004. The Danish Veterinary and Food Administration created a fact sheet on fluorinated substances in paper and board for food-contact materials.
Many phthalates, including ortho-phthalates, are authorized for use in the manufacture of food-contact materials in the EU. However, their use may be strictly regulated under EU or Member State legislation. For example, while the Plastics Regulation (EU) No. 10/2011 lists several phthalates as additives, in some cases, their permitted use is very limited and, notably, they are often not authorized for use in packaging for food intended for infants and young children. Several EU Member States, but most notably France, have national legislation in place prohibiting the placing on the market of certain food contact materials containing bisphenol A (BPA).
The Draft for EU Regulation on BPA
The European Commission is currently working on a draft Regulation on the use BPA in varnishes and coatings intended to come into contact with food and amending the Plastics Regulation (EU) No 10/2011. The current draft outlines that it will apply six months after its entry into force (although an exhaustion of stocks clause would apply). The draft sets a specific migration limit (SML) of 0.05 mg/kg for BPA in plastics, varnishes, and coatings based on the EFSA’s 2015 opinion (by contrast to the current SML of 0.6 mg/kg set out in the Plastics Regulation). It remains to be seen how Member State BPA laws will be addressed if/when this new EU measure is adopted.
The Migration of Mineral Oil
The migration of mineral oil from food packaging to food has also been under the spotlight. Notably, the German Federal Ministry for Food and Agriculture (BMEL) had been working on a draft Ordinance on mineral oil saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH) for several years now. The third draft of this Ordinance proposed to set SMLs for MOSH (C20-C35): 2 mg/kg of food and MOAH (C16-C35): 0.5 mg/kg of food. Since then, the Council of Europe has also been working on draft “Technical Guidelines on Paper and Paperboard,” which incorporate identical SMLs for MOSH and MOAH, although the limits are still under discussion. Although Council of Europe guidelines are not legally binding, once final, they are referred to in practice by Member States for safety evaluations, in the absence of national rules. Hence, it remains to be seen whether Germany will proceed to adopt its draft Mineral Oil Ordinance. However, following up on these initiatives, the European Commission is currently working on a Recommendation on the monitoring of mineral oil hydrocarbons in food and packaging materials.
The European Parliament’s Approach
Finally, it is also noteworthy that the European Parliament (EP) Committee on Environment, Public Health and Food Safety is focusing more on the use of particular substances in food-contact materials (FCM). It published a draft own-initiative report on the implementation of the EU’s Framework Regulation (EC) No. 1935/2004 (i.e., the overarching legislation applicable to all food contact materials that are placed on the market in the EU) in April 2016. The draft includes a motion for a resolution which calls on the European Commission to, inter alia, “ensure a better coordination between the REACH Regulation and FCM legislation, especially as regards substances classified as SVHCs [substances of very high concern] under REACH.” This motion is expected to be examined by the EP in September 2016.
The above are simply examples of some of the many substances that are currently or may come into greater focus in the near future. However, these limited examples certainly highlight the need for business operators to keep up to date with the evolving approach of both the U.S. and EU/Member State authorities with respect to the safety of food contact substances, and to take the necessary steps to adapt in time to ensure continued compliance of food contact materials and articles with the applicable requirements.
This article first appeared in the July/August 2016 issue of European Coatings Journal and is reprinted by permission.
[1] Prior sanctioned substances are substances for which letters were issued by the FDA or the USDA (U.S. Department of Agriculture) prior to 1958 raising no objection to a specific use in or on food.