Migrations des emballages : un grand trou dans la sécurité alimentaire et comment on pourrait le remplir.

Transcription

1 Migrations des emballages : un grand trou dans la sécurité alimentaire et comment on pourrait le remplir. Koni Grob Kantonales Labor Zürich

2 FCM: the largest gap in food safety? Migrates from FCM might be the quantitatively largest source of food contamination: normally 1-10 mg/d times higher than that of pesticide residues Roughly 1500 starting substances are evaluated and authorized, but migrates consist of ~100,000 substances of molecular mass <1000 Da and migrating >TTC Assurance of safety of migrates from FCM is just at the beginning of the work first step: starting substances describing the type of chemistry involved but the majority of the migrating substances are not starting substances

3 Main problem: ORPIs Oligomers, Reaction Products, Impurities Non Intentionally Added Substances (NIAS) is an inadequate term insinuates reduced responsibility alludes to jurisdiction taking intention into account for the specification of penalty ORPIs: usually major part of the migrate the overall migration usually far exceeds the sum of the specific migrations tested ORPIs typically constitute % for can coating % for polyolefins

4 Compliance work for ORPIs may be demanding Food safety = absence of substances endangering human health presupposes comprehensive analysis, which is demanding Common analysis is targeted to known substance comprehensive: unselective extraction, no preseparation ( cleaning ), unselective detection, universal detection, preferably with same response disregarding the substance (FID) Detection limit responding to regulatory toxicology Many substances may have the same relevant functionality Comprehensive analysis in food is usually impossible Extracts of the FCM with an estimated migration No standards available for analysis and toxicology feasible only with limitations

5 Would you sign this declaration? Imagine: You would like to sell your product through a large retailer who asks you to sign the following certification: The issuer of the conformity declaration hereby certifies that the food packaging described below (with all the relevant components such as films adhesives, print colours etc.) meets the specifications of Swiss food legislation (food and commodities ordinance and the consumer goods ordinance) and the relevant EU legislation (1935/2004 and 2023/2006) and is therefore marketable in Switzerland and the EU.

6 What would you sign? EU Regulation 1935/2004: Materials and articles shall be so that they do not transfer their constituents to food in quantities which could: (a) endanger human health refers to all substances migrating at relevant amounts

7 Substances migrating in «relevant amounts» Thresholds of regulatory toxicology «not detectable» by the conventional EU detection limit in food of 0.01 mg/kg not derived from toxicology, outdated Threshold of Toxicological Concern (TTC) statistically derived from evaluated substances exposure-related tiered thresholds 0.15 µg/person/day for possible genotoxic carcinogens 90 µg/person/day if no CMRs Cramer classes unidentified substances (could be genotoxic): 0.15 µg/person/day if substance is present in 150 g food: mg/kg

8 Example 1 Gasket of lids extract from gasket, GC-FID Internal standards GC-FID Oleamide Erucamide Diisodecyl phthalate

9 Example 1 Gasket of lids extract from gasket, GC-FID Internal standards GC-FID 0.15 % related to gasket: is it relevant? Oleamide Erucamide Diisodecyl phthalate

10 Example 1 Threshold of control 300 mg gasket material in food contact 0.15 % ~ 450 µg oily products: virtually complete migration 450 µg in 100 g jar X = 4.5 ppm Threshold of Toxicological Concern (TTC): 0.15 µg/d Assumed average daily consumption of 150 g food in contact with PVC (lids, films) 1.5 µg/100 g food 1 µg/kg x 4500

11 Example 1 Gaskets of lids for glass jars Extract from the gasket of a metal closure GC-FID Internal standards Threshold of concern Unknown is 4500 times below this concentration ca % Oleamide Erucamide Diisodecyl phthalate

12 Example 2 Straight PP film with Irgafos mg/kg C12 1 (int. stand.) Additive 2 (Irgafos 168) 3 POSH Monomer? propylene: evaporated! Irgafos 168 I 168 I 1 68 ox ,6-DTB Q 2,4 -DTBP I 168 ox1 2,6-DTBQ 2,4-DTBP oxa spiro 18-acid 16-acid I 16 8 d eg 16-acid 1 8-a cid On-line HPLC-GC-FID HPLC preseparation on silica gel R. Castillo, M. Biedermann, A.M. Riquet, K. Grob Polymer Degradation and Stability 98 (2013) 1679

13 Example 2 Thresholds of potential health relevance C12 1 (int. stand.) mg/kg of single substance in film may result in 0.01 mg/kg in food (conventional detection limit) Irgafos 168 I 168 I 1 68 ox1 1 mg/kg ,6-DTB Q 2,4 -DTBP I 168 ox1 2,6-DTBQ 2,4-DTBP oxa spiro 18-acid 16-acid I 16 8 d eg 16-acid 1 8-a cid 0.1 mg/kg as detection limit derived from TTC concept (0.001 mg/kg) Polyolefins are the best regulated FCM

14 Example 3 Migration from epoxy-phenol coating FD Simulation of sterilized oily foods, NPLC, fluorescence only regulated component BADGE BADGE.tBuPhe BADGE.HCl +? BAMGE cyclo-diba Dimer Trimer ca. 50 ppb in food (~50 times above TTC) (min) K. Grob, P. Camus, N. Gontard, H. Hoellinger, C. Joly, A.C. Macherey, D. Masset, F. Nesslany, J.F. Régnier, A.M. Riquet, P. Saillard and D. Ribera. Food Control 21 (2010) 763

15 Example 4 Recycled paperboard: HPLCxGC-FID HPLC Pyridine DIPN Aromatic hydrocarbons 24 MOSH Baseline MOAH 24 n-alkanes representing 0.1 mg/kg in paperboard

16 Blocked situation Industry: why to invest money to reveal problems? Inevitably problematic substances would be found Too large a work to satisfy legal requirements better not to start Enforcement: almost all FCM would have to be rejected Has to enforce present legislation Cannot tolerate what has not been legal for many years Cannot take everything from the market Only option: not to perform control Legislator: requirements far beyond reality but cannot reduce requirements, such as safety must be ensured if readily possible DG-SANCO seems disoriented: no substantial action since 2006 Best option: keep quiet

17 First step into promising direction GMP specifies responsibilities Legal requirement to sign declaration of compliance enables tracing the responsible business operator Those introducing a substance are responsible for the safety of the substance itself, its impurities and reaction products at this or later manufacturing stages Responsible manufacturer has the options of concluding compliance work delegating compliance work: customer is informed about work left to be performed not delegated work automatically falls into responsibility of the business operator signing the declaration

18 but GMP does not help out of deadlock Clear distribution of the responsibilities engages all manufacturers in the chain distributes the jobs but does not initiate filling the gaps more flexible and pragmatic approach required gap between requirements and reality is too large gaps cannot be filled tomorrow some work may not be feasible, but the feasible work should be done in reasonable time certain methods are questionable, but may be the best available driven not by (rigid) legislation, but by enforcement authorities

19 1st step Rendering reality acceptable 1. Vendors must have the possibility to accept declarations with certain gaps but need being backed 2. Authorities know that most concluding compliance declarations are not based on adequate compliance work and should have the possibility to temporarily accept this Situation rendered acceptable through work plans on filling the gaps temporarily acceptable disclaimers if linked to work plans

20 2nd step Specification of gaps The responsible operators (producers, producer associations or other consortia) define the gaps, e.g. oligomers from PP reaction products and impurities of additives Gap description (GD) All gaps have to be covered by a GD by a given time GD are registered, e.g. by EFSA to be delivered with a time limit Publicly available: general description owners of the GD: companies involved

21 3rd step Elaboration of work plans Main steps: 1. Chemical background/expected types of relevant substances 2. Estimate of amounts in the FCM and potential migration 3. Analytical approach 4. Expected limitations in the analytical work 5. Planned approach for toxicological evaluation 6. Estimated time lines, with milestones for larger projects Work plans must be specific and realistic. It must explained if regulatory targets are out of reach.

22 4th step Approval of the work plans Work plans are submitted to authorities with adequate competence (e.g. EFSA, BfR, Anses) Does the subject matter merit a work plan? Gaps from sheer carelessness are not acceptable Is the work plan acceptable? Identification work with regard to comprehensiveness and detection limit Approach for toxicological evaluation? Are limitations convincingly justified Time lines and milestones? Is the envisioned safety assurance promising to be satisfactory? Otherwise GD is inacceptable and the product must be phased out Progress must be periodically reported Serious failures result in withdrawal of the GD from the list

23 5th step Application to compliance declarations Approved GD can be used for compliance declarations: final compliance declarations must be conclusive, either by supporting documentation (concluded work, as today) or gaps specified by GDs Control: GD must be approved and registered ( registration) supplier must be (co)owner of the work plan his product must be included in the work described by the GD the date of completing the work plan/milestones must not be exceeded

24 A new approach is needed: work plans? Deblocks the present situation Enables temporary acceptance of incomplete compliance work Work plans provide room for flexibility Temporary compromises on compositional analysis and toxicological evaluation Procedure may be in steps Time lines can be adjusted Promotes dialog between industry and authorities