The long-awaited comprehensive reform of the EU legislation on food contact materials (FCM) Food Contact Material) is delayed again. The preliminary report of the European Commission – after two years of consultations (workshop, seminars, consultations) with stakeholders (producers and associations) – will be published in 2022, instead of April 2020. This was announced by Bastian Schupp, official of DG SANTE, at the annual conference of Chemical Watch 11-12.2.20 in Brussels. (1)
FCM, the snail reform
43 years since the first act regulations on materials in contact with food (Directive 76/893/EEC, repealed by Reg. EC 1935/2004), Europe still seems to be moving away from a harmonized discipline of an industrial sector often causing serious risks to public health. Its production in Europe represents an annual turnover of about 100 billion euros, half in the plastic, paper, and cardboard segments. (2)
The postponement of the document final evaluation of FCM is linked to the political decision to align its timing with the impact assessment of the current legislation. According to the indicated calendar, this should start this year and be published early 2022. Only afterwards will the Commission adopt a proposal for a comprehensive reform of the European FCM regulation.
The European legislation on FCM thus remains essentially based on two horizontal regulations, applicable to all materials and articles intended to come into contact with food:
– Reg. (EC) 1935/04, containing general criteria, mirroring the so-called General Food Law (reg. EC 178/02),
– reg. (EC) 2023/06, relating to GMP (Good Manufacturing Practices) of the sector.
Few harmonized vertical regulations
Vertical regulations harmonized apply only to some FCM – ceramic materials, regenerated cellulose films, plastics (including recycled plastics), active and intelligent materials.
Three other regulations deal with some substances used or present in FCM:
– reg. (EU) 2018/213 on the use of bisphenol A in varnishes and coatings intended to come into contact with food,
– reg. EC 1895/2005, which limits the use of certain epoxy derivatives in FCM,
– directive 93/11/EEC on the release of N-nitrosamines and N-nitrosable substances from rubber teats and pacifiers.
The vast majority of FCM is still lacking specific harmonized measures at the EU level. This is the case for adhesives, cork, glass, ion-exchange resins (used in water treatment filters), metals and alloys, multi-materials, paper and cardboard, inks, rubber, silicone, paints and coatings, wax, wood and bamboo. Although these materials are very common in food packaging and everyday objects in contact with food and beverages, toxicities are recurrent.
Plastic FCM, updates
Plastic FCM are governed by reg. (EC) No 10/2011. It is the most comprehensive and detailed vertical regulation in this field, which codifies the composition of plastic FCM and provides the list of substances authorized for the manufacture of materials intended to come into contact with food. In addition to establishing usage restrictions and compliance standards.
The regulation on FCM in plastic is subject to continuous updates. In the coming months two further amendments will be introduced, adding to the 14 already adopted:
– the 15th amendment, with entry into force expected in the second four-month period of 2020, concerns, among other things, the inclusion of three substances in the list of those usable (Montmorillonite clay modified with hexadecyltrimethylammonium bromide, phosphorous acid, triphenyl phosphate, polymer with alpha-hydro-omega-hydroxy poly [oxy (methyl-1,2-ethanediol)], alkyl ester C10-16) and titanium dioxide surface treated with alumina modified with fluoride, also in nanoparticle form, (3)
– the 16th amendment, awaited for the third quarter 2020, still in progress, it should admit other substances to the list of those usable and take into account the opinions of the European Food Safety Authority (EFSA) on the use of woody fibers and phthalates in food contact materials (FCM). For 5 of the latter, the opinion was published just two months ago.
EFSA opinion on phthalates
In December 2019, EFSA published the update of the risk assessment of 5 phthalates, chemical substances used to soften (or 'plasticize') some materials also used in FCM. It set a new safety level in terms of tolerable daily intake (TDI), that is the estimate of the amount of a substance that a person can ingest daily throughout their lifetime without appreciable health risk.
Compared to the previous 2005 assessment, EFSA set a group TDI of 50 micrograms per kg of body weight (µg/kg bw) per day for four of the five phthalates (DBP, BBP, DEHP and DINP). It confirmed a separate TDI, equal to 150 µg/kg bw, for the only fifth phthalate under consideration, DIDP.
The assignment entrusted to EFSA by the European Commission concerns only the toxicity of phthalates on the reproductive system. A possibility largely demonstrated for the first 4 phthalates (decrease of testosterone in fetuses), but not for the fifth (although highly toxic to the liver).
The TDIs, EFSA emphasizes, are set on a temporary basis, 'due to uncertainties about effects other than reproductive ones and the contribution of plastic FCMs to the overall consumer exposure to phthalates'. At current exposure levels, however, the 5 phthalates 'do not pose public health concerns'. Dietary exposure to the group of 5 is on average 7 µg/kg bw, 7 times below the safety level, while for high consumers it is 12 µg/kg bw, i.e. four times lower. For DIDP, dietary exposure for high consumers is 1,500 times lower than the safety level.
Notes
(1) See. https://www.foodpackagingforum.org/news/conference-on-european-food-contact-regulations
The FCM market in Europe represents an annual turnover of about 100 billion euros. Plastic together with paper and cardboard represent 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 share of small and medium-sized enterprises even though their contribution to turnover is limited’. Non-harmonised food contact materials in the EU: regulatory and market situationThe MMF market in Europe represents an annual turnover of approximately 100 billion euros. Plastic together with paper and cardboard represent more than half, followed by glass, metal and machinery. The adhesives, inks, resins, waxes, ceramics, cork, wood, rubbers, silicone and coatings sectors are smaller. Many sectors have a significant proportion of small and medium-sized enterprises even if their contribution to turnover is limited. Non-harmonised 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, has worked for newspapers (Il Messaggero, Paese Sera, La Stampa) and magazines (NumeroUno, Il Salvagente). Author of investigative journalism on food, she published the volume 'Reading labels to know what we eat'.
