The long-awaited organic reform of the EU’s Food Contact Material (MOCA or FCM) framework slips forward again. The European Commission’s preliminary report-after two years of discussions(workshops, seminars, consultations) with stakeholders (producers and associations)-will be published in 2022, instead of April 2020. So announced Bastian Schupp, DG SANTE official, at Chemical Watch ‘s annual conference on 11-12.2.20 in Brussels. (1)
MOCA, the reform-slug
Forty-three years after the first piece of legislation on food contact materials (Directive 76/893/EEC, repealed by EC Reg. 1935/2004), Europe still seems to be moving away from harmonized regulation of an industrial sector that is often the cause of serious public health risks. The production of which accounts for annual sales of about 100 billion euros in Europe, half of which is in the plastics, paper and cardboard segments. (2)
The postponement of the final MOCA assessment document is related to the political decision to align its timing with the impact assessment of current legislation. Which, according to the timetable given, is expected to begin this year and reach publication in early 2022. And only then will the Commission adopt a proposal for a comprehensive reform of the European MOCA framework.
European legislation on MOCAs therefore remains essentially based on the two horizontal regulations, applicable to all materials and articles intended to come into contact with food:
– reg. (EC) 1935/04, laying down general criteria, mirroring the so-called General Food Law (reg. EC 178/02),
– reg. (EC) 2023/06, on industry GMP(Good Manufacturing Practices).
Few harmonized vertical standards
Harmonized vertical standards exist only for some FCMs-ceramic materials, regenerated cellulose films, plastics (including recycled plastics), active and smart materials.
Three other regulations deal with certain substances used or present in MOCAs:
– reg. (EU) 2018/213 on the use of bisphenol A in paints and coatings intended to come into contact with food,
– reg. EC 1895/2005, restricting the use of certain epoxy derivatives in MOCAs,
– Directive 93/11/EEC on the release of N-nitrosamines and N-nitrosatable substances from rubber nipples and pacifiers.
By contrast, most MOCAs still lack specific measures harmonized at the EU level. This is the case for adhesives, cork, glass, ion exchange resins (used in water treatment filters), metals and alloys, multimaterials, paper and cardboard, inks, rubber, silicone, paints and coatings, wax, wood, and bamboo. Although these are materials found widely in food packaging and everyday objects in contact with food and drink, and toxicities are recurrent.
MOCA plastic, updates
Plastic MOCAs are regulated by Reg. (EC) No. 10/2011. It is the most comprehensive and detailed vertical regulation in this area, codifying the composition of plastic FCMs and providing the list of substances allowed in the manufacture of food contact materials. As well as establishing usage restrictions and compliance standards.
The regulation on plastic MOCAs is subject to continuous updates. Two more changes will take place in the coming months, adding to the 14 already adopted:
– The 15th amendment, with entry into force expected in the second quarter of 2020, concerns, among other things, the inclusion of three substances to the list of those that can be used (montmorillonite clay modified with hexadecyltrimethylammonium bromide, phosphoric acid, triphenyl ester, polymer with alpha-hidr-homega-hydroxypoly [ossi (metil-1,2-etandiolo)], C10-16 alkyl ester) and surface-treated titanium dioxide with fluoride-modified alumina, also in nanometer form, (3)
– the 16th amendment, expected in the third quarter of 2020, which is still in progress, is expected to admit additional substances to the list of those that can be used and to take into account the opinions of the European Food Safety Authority (EFSA) on the use of woody fibers and phthalates in MOCAs. For 5 of the latter, the opinion came to publication just two months ago.
EFSA’s opinion on phthalates
In December 2019, EFSA published an updated risk assessment of 5 phthalates, chemicals used to soften (or ‘plasticize’) some materials also used in MOCAs. And it has set a new safe level in terms of tolerable daily intake (TDI), which is an estimate of the amount of a substance that humans can ingest on a daily basis over the course of an entire lifetime without any appreciable health risk.
Compared with the previous assessment in 2005, EFSA set a group TDI at 50 micrograms per kg body weight (µg/kg pc) per day for four of the five phthalates (DBP, BBP, DEHP and DINP). And confirmed a separate TDI of 150 µg/kg pc for only the fifth phth phthalate under consideration, DIDP.
The assignment given to EFSA by the European Commission concerns only the toxicity of phthalates on the reproductive system. A possibility widely demonstrated for the first 4 phthalates (decreased testosterone in fetuses), but not for the fifth (nonetheless highly toxic to the liver).
TDIs, EFSA points out, are set on a temporary basis, ‘because of the margins of uncertainty about effects other than reproductive and the contribution of plastic FCMs to overall consumer exposure to phthalates.’ At current levels of exposure, however, the 5 phthalates‘do not pose public health concerns.’ Dietary exposure to the group of 5 averages 7 µg/kg pc, 7 times below the safe level, while for heavy consumers it is 12 µg/kg pc, which is four times lower. For DIDP, the dietary exposure for heavy consumers is 1,500 times lower than the safe level.
Notes
(1) SEE https://www.foodpackagingforum.org/news/conference-on-european-food-contact-regulations
(2) ‘The MMF market in Europe represents an annual turnover of about 100 billion euros. Plastic along with paper and cardboard account for more than half, followed by glass, metal and machinery. The sectors of adhesives, inks, resins, waxes, ceramics, cork, wood, rubbers, silicone and coatings are smaller. Many sectors have a significant proportion of small and medium-sized enterprises even if their contribution to turnover is limited’. Non-harmonized food contact materials in the EU: regulatory and market situation, JRC 2017
(3) SEE https://www.foodpackagingforum.org/news/draft-15th-amendment-to-eu-plastic-fcm-regulation
(4) Vittorio Silano, José Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Alicja Mortensen, Gilles Rivière, Inger-Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Jean-Pierre Cravedi, Cristina Fortes, Maria de Fatima Tavares Poças, Ine Waalkens-Berendsen, Detlef Wölfle, Davide Arcella, Claudia Cascio, Anna F Castoldi, Katharina Volk, Laurence Castle. Update of the risk assessment of di-butylphthalate (DBP), butyl-benzyl-phthalate (BBP), bis(2-ethylhexyl)phthalate (DEHP), di-isononylphthalate (DINP) and di-isodecylphthalate (DIDP) for use in food contact materials. EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) https://doi.org/10.2903/j.efsa.2019.5838
Professional journalist since January 1995, he has worked for newspapers (Il Messaggero, Paese Sera, La Stampa) and periodicals (NumeroUno, Il Salvagente). She is the author of journalistic surveys on food, she has published the book "Reading labels to know what we eat".
