December 7, 2022

Volume XII, Number 341

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December 05, 2022

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MOAH in Food: New October Statement Poses Broader Issues for Operators in the Food and Food Contact Materials Supply Chain in EU

Mineral oil aromatic hydrocarbons (MOAH) are increasingly becoming a topic of concern for food and food contact material operators in the European Union. Following a report by an NGO, the European Commission and Member States (through the SCoPAFF committee) issued a statement in April 2022, defining non-legally binding thresholds for MOAH in food products. A new statement, to be issued on October 19, will provide additional details, requiring an increased attention from all involved.

2017-2019 EU Monitoring of MOAH in Foods

In 2017, the European Commission (EC) adopted Recommendation (EU) 2017/84[1] to ask European Union (EU) Member States to monitor the presence of mineral oil hydrocarbons (MOH) in food and to determine whether their presence was due to migration from materials and articles in contact with such food.

Following the EC's initiative, investigations and analyses were conducted by national authorities, food business operators, and NGOs involved in this area, such as Foodwatch.

As a result, in 2019, mineral oil aromatic hydrocarbons were found in some foods targeting specific population groups (e.g., baby food and food for special medical purposes).

The European Food Safety Authority (EFSA) conducted a Rapid Risk Assessment and the EU regulatory committee on food safety (SCoPAFF), chaired by the EC and where all Member States are represented, issued a Statement (dated June 23, 2020) concluding that “in the absence of information on the presence or absence of 3-7 ring polycyclic aromatic compounds (3-7 PAC), the detection of mineral oil aromatic hydrocarbons (MOAH) in food should be considered of potential concern for human health.” 

Foodwatch’s 2021 Findings

In December 2021Foodwatch published the results of a study carried out on 152 food products from five different European countries (France, Germany, Belgium, the Netherlands, and Austria):

  • 19 products (12.5%) were found to be contaminated with mineral oil aromatic hydrocarbons (MOAH)

  • 140 products (92%) were found to be contaminated with oil saturated hydrocarbons (MOSH)

Subsequently, Foodwatch widely communicated these findings to the EC and EU Member States.

The Statement of the SCoPAFF of April 2022 recommends having food recalled or withdrawn from the market when the presence of MOAH in food is at or above the limits of the quantification set.

On April 21, 2022, the SCoPAFF, addressing Foodwatch’s report, released a statement recommending to “withdraw and, if necessary, to recall products from the market, when the sum of the concentrations of MOAH in food are at or above the following maximum LOQs [Limits of Quantification]:

  1. 0.5 mg/kg for dry foods with a low fat/oil content (≤ 4% fat/oil);

  2. 1 mg/kg for foods with a higher fat/oil content (> 4% fat/oil);

  3. 2 mg/kg for fats/ oils.”

New elements added to the April 2022 Statement by contrast to the June 2020 Statement:

  1. the need to check the presence of MOAH in microcrystalline wax used in food contact materials (FCM) and its migration into food products[2]; and 

  2. when microcrystalline wax used in food contact materials is the food-grade E 905 microcrystalline wax authorized as a food additive, the need to check whether it complies with the specifications of E 905, particularly regarding the presence of benzo[a]pyrene.[3] 

We recall that microcrystalline wax falls under FCM No 94 of Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food and, as such, is authorized for use as an additive in plastic food contact materials and articles. 

Also, microcrystalline wax is listed in the German Federal Institute for Risk Assessment (BfR) Recommendation XXV (where it is defined as “mixtures of solid, purified, mainly branched, saturated microcrystalline hydrocarbons derived from petroleum”) for its use in the manufacture of impregnations, coatings and contact adhesives for foodstuff packaging and other food contact materials and articles.

It is important to note that the thresholds stated in this SCoPAFF statement are not, as such, legally binding throughout the EU, but they can be considered and made binding at the national level if a national authority decides to do so.

The EC is now contemplating clarifying the April statement during the next 19 October meeting with the EU Member States.

The European Commission has prepared a working paper ahead of the October 19 meeting proposing to clarify some aspects of the April SCoPAFF statement.

According to this document:

  • the April statement refers to all types of foods "as sold" and regardless of the source of MOAH; and

  • the MOAH concentration mentioned therein covers the fraction >C9 to ≤C50.

In addition, it is our understanding that the MOAH concentration thresholds are updated as follows (changes in bold):

  1. “0.5 mg/kg for dry foods with a low fat/oil content (≤ 4% fat/oil);

  2. 1 mg/kg for foods with a higher fat/oil content (> 4% fat/oil, ≤50% fat/oil);

  3. 2 mg/kg for fats/ oils or foods with >50% fat/oil.”

It seems that this clarification relates directly to the Joint Research Centre (JRCGuidance on sampling, analysis, and data reporting for the monitoring of mineral oil hydrocarbons in food and food contact materials.[4] The JRC Guidance, indeed, considers MOSH as the total mass fraction of MOSH (C10-C50) and MOAH as the total mass fraction of MOAH (C10-C50), setting the LOQ max for the latter at 0.5 mg/kg.

In addition, according to the JRC Guidance, the "LC-GC-FID method is referred to as the method of choice for the quantification of mineral oils in routine analysis". This is a point that companies should consider when performing risk assessments on their products. Indeed, it is notably recognized by experts that it does not perform well enough to distinguish the MOAHs of most concern, which should definitely not be present in food [i.e., 3-7 PAC], from the others (which could then be considered as "false positives"). Food business operators and the EU Member States may discuss analytical problems leading to potential false positives and disproportionate and, therefore, unjustified recalls and withdrawals.

At the same time, EFSA is expected to update its scientific opinion on MOSH and MOAH, but the publication of such an opinion is not expected prior to early 2023

Discrepancies with Current Legislation in the EU Member States

Different requirements and limits are currently set in some Member States and these limits are not aligned and do not cover the same carbon chains as the October 2022 document.

In Francethere is a specific ban that will become applicable as of January 1, 2025, for certain mineral oil hydrocarbons that may be present in printing inks.[5] Notably, France will prohibit the use of MOAH with 1-7 aromatic rings and MOSH with 16-35 carbon atoms when their mass concentration in such inks is greater than 0.1% [or the mass concentration in ink of MOAH compounds with 3 -7 aromatic rings is greater than one part per million (ppm)].

In Germany, the Twenty-second Ordinance Amending the Consumer Goods Ordinance, under discussion in the Bundesratlimits the definition of MOAH to alkylated aromatic hydrocarbons with carbon numbers C16-C35 which contain one or more rings, with the exception of diisopropylnaphthalenes.

According to the amendment, FCMs and articles made of papercardboard, or paperboard manufactured using recovered paper pulp must be separated from food, with some exceptions, by a functional barrier to prevent migration of MOAH to food.

Migration of MOAH is considered not to occur only if:

  1. the detection limit of 0.5 mg/kg (sum of MOAH), when measured in food, is not exceeded; or,

  2. the detection limit of 0.15 mg (sum of MOAH), when measured using food simulant, is not exceeded.

The bill was notified to the EC on August 17, 2020 (TRIS 2020/510/D) and its standstill period ended on February 18, 2021. It was also notified to the WTO on March 22, 2021.

Currently, the draft is under scrutiny by the relevant committees of the Bundesrat before going to the plenum and then being published in the German official journal (Bundesgesetzblatt).

Besides this new proposed bill, which is closely related to FCMs and articles made from recycled paper, in Germany, there are also recommendations,[6] in which reference levels are set for MOSH for different food categories, while for MOAH the applicable reference levels correspond to the LOQ max of the JRC guide. In Belgium, the Scientific Committee of the Federal Agency for the Safety of the Food Chain (FAVV-AFSCA) has followed a similar approach with its Advice 19-2017.

As one can easily foresee, in the absence of (i) a harmonized definition of MOAH, (ii) identification of a reliable method of analysis, and (iii) safety limits in food products (which should not simply correspond to limits of quantification), Member states are taking different positions that may lead to significant legal issues in the case of withdrawals or recalls being decided in one Member State and not in another.


FOOTNOTES

[1] Commission Recommendation (EU) No 2017/84 of 16 January 2017 on the monitoring of mineral oil hydrocarbons in food and in materials and articles intended to come into contact with food, available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017H0084&from=EN

[2] Analysis must be carried out in accordance with the provisions set in Regulation (EC) No 333/2007.

[3] It should be noted that the BfR does not set any limits on the presence of MOAH (or the specific fraction of MOAH of concern) or Benzo(a)pyrene [or other types of polycyclic aromatic hydrocarbons (PAHs)] in the specifications for paraffin waxes used in food contact materials made of paper and board (see BfR Recommendation XXV).

[4] Bratinova, S. and Hoekstra, E., Guidance on sampling, analysis and data reporting for the monitoring of mineral oil hydrocarbons in food and food contact materials, EUR 29666 EN, Publications Office of the European Union, Luxembourg, 2019, ISBN 978-92-76-00172-0, doi:10.2760/208879, JRC115694, available at https://publications.jrc.ec.europa.eu/repository/handle/JRC115694

[5] The substances concerned by the ban on the use of mineral oils are:

  1. MOAH with 1-7 aromatic rings;

  2. MOSH with 16-35 carbon atoms.

Until December 31, 2024, the ban on the use of mineral oils applies when the concentration of MOAH by mass in the ink is greater than 1%.

As of January 1, 2025, the ban on the use of mineral oils applies:

  1. for MOAH, when the mass concentration in ink of these substances is greater than 0.1% or the mass concentration in ink of compounds with 3-7 aromatic rings is greater than one part per million (ppm);

  2. for MOSH, when the mass concentration in the ink of these substances is greater than 0.1%.

[6] The document has been issued by the representatives of the food control authorities of the regional States (Länders) and the Lebensmittelverband Deutschland e. V. (German Food and Drink Federation).

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 287
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Rachida Semail Food Packaging Attorney Keller Heckman
Partner

Rachida Semail is a partner in the Brussels, Belgium office, affiliated with the Paris bar (France).

Ms. Semail assists clients with food packaging matters, particularly with the establishment of suitable EU status for articles and materials intended for food-contact. She has extensive experience on subject matters not harmonized at the EU level, as is the case in much of the food-contact sector, where mutual recognition is of paramount importance. Ms. Semail’s food law expertise includes enzymes, flavorings, and food additive clearances of...

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Luca Galizia Brussels Food Lawyer Keller & Heckman
Associate

Luca Galizia is an Associate out of Keller & Heckman's Brussels office. He counsels European Union (EU) and international clients on regulatory and compliance matters in food, with an emphasis on food additives, food supplements, novel foods, and borderline products (i.e., herbal medicinal products, substance-based medical devices, etc.). He also assists clients with food contact law. In particular, he assists companies in assessing the regulatory status of food and food additives, in understanding the intricacies of advertisement for food supplements and other food...

32-0-2-645-5093
Elisa Giusto Associate Keller and Heckman LLP
Associate

Elisa Giusto counsels clients on regulatory and compliance matters in food and drug law, with an emphasis on food-contact materials, food additives, packaging for drugs, medical devices and cosmetics. She assists companies in establishing a suitable status for food packaging articles and materials in the European Union (EU), Member States, and other European countries. She also advises clients with respect to the principle of mutual recognition.

Prior to joining Keller and Heckman, Elisa worked for an Italian law firm, where she assisted Italian...

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