Safe Adhesives for Food Packaging: Risk Assessment Toolbox Packaged Summit 19 June 2107 Amsterdam Alexandra Roß Product Regulatory Specialist EIMEA
2 Agenda H.B. Fuller at a Glance Packaging and Packaging Adhesives Media Attention Monitoring the Risk from Packaging Adhesives What is mineral oil and where does it come from? Food Safe Packaging with H.B. Fuller
H.B. Fuller at a Glance 3
Beverage Labeling Packaging Solutions Flexible Packaging Carton Package Sealing Retail- Ready E-commerce
Packaging and Packaging Adhesives 5
6 Purpose of Packaging Communication Convenience Food & Beverage Packaging Protection Preservation
Typical Packaging Types & Adhesive 7 Portion Pack in Stand-Up Pouch Hot melt beads on cartons Label or Tape on a Pack Water-base glue on folding cartons
Media Attention 8
9 Source: Food Quality News http://www.foodqualitynews.com/regulation-and-safety/dutch-wafflesand-cheese-biscuits-mineral-oil-contamination
10 Source: BBC http://www.bbc.com/news/world-europe-11843820
11 Source: EFSA https://www.efsa.europa.eu/en/topics/topic/bisphenol
12 Source: European Parliament News http://www.europarl.europa.eu/news/en/headlines/society/20151013sto97392/eightthings-you-should-know-about-gmos
Frequent precautionary recalls due to contamination with plastic, metal or other foreign objects 13 Source: Produkt Warnung https://www.produktwarnung.eu/rubrik/lebensmittel
Responsibility Stress Field within the Supply Chain 14 Material knowledge Adhesive Producer Packaging Producer Media Pressure Food Producer Retail CONSUMER
Monitoring the Risk from Packaging Adhesives 15
Adhesives in the 'Regulation Jungle' 16
Food Contact Regulation & Control Kind and amount of substances Adhesives Supplier Type of Food Packaging Construction Food Industry Migration Monitoring & Control Packaging Producer Contact time and Temperature Barrier of the Packaging Surface / Volume Ratio
18 What is the Risk of Adhesives? Risk = Hazard x Exposure Possible migration into food should not endanger human health (Article 3, Regulation (EC) No 1935/2004) Hazard: Toxicity Exposure: Effective amount, the consumer is exposed to
Raw Material and Adhesive Related Evaluation Raw Material Data Gathering Compositional Information Compliance Information Cross check with FEICA Rejection list Raw Material Evaluation Compliance with which regulation Are there small substances that have not been evaluated <1,000 Dalton (detailed risk evaluation) Adhesive Related Evaluation Summary of information for all raw material Suitability for intended use Draft food contact declaration Source: FEICA Food Contact Guidance
20 Toolbox for Raw Material Evaluation Comp. A FDA 175.105 Comp. B Comp. C Comp. D Comp. E Comp. F Plastics Regulation (EU) No 10/2011 (specific restrictions to be considered) BfR Recommendation (e.g.) XIV, XXV Adequate Information Food Contact Status Declaration
Adhesive Assessment by Adhesive User 21 Packaging Material = Functional Barrier? Is migration possible based on intended use? Are the potential migrating substances and their quantities known? Considering Surface / Volume Ratio? Worst-Case-Calculation? Possible Modeling or Migration Testing? Source: FEICA Guidance for Food Contact Declaration for Adhesives
What is mineral oil and where does it come from? 22
23 Consumers are exposed to a range of mineral oil hydrocarbons (MOH) via food MOSH Mineral oil saturated hydrocarbons may accumulate in several tissues (C16-C35) MOAH mineral oil aromatic hydrocarbons may be mutagenic and carcinogenic, and therefore of potential concern Major sources of MOH in food are food packaging and additives, processing aids, and lubricants Source: https://www.efsa.europa.eu/en/efsajournal/pub/2704
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25 Sources of mineral oil in food / food packaging Solvents in newspaper printing inks Remain in cardboard boxes from recycled paper Elimination during the recycling process is not efficient today. Dry foods packed in recycled cartons run a higher risk of mineral oil contamination
MOSH and MOAH fractions in Adhesives Hot Melts Waxes, Hydrocarbon resins Applications: Case & Carton Sealing Pressure Sensitive Hot Melts Oils, Waxes, Hydrocarbon resins Applications: Labels, Tapes Water-based Defoamer (in general not more than 0.5%) Applications: Packaging Construction, Labeling Source: FEICA Mineral Oil Factsheet
MOSH / MOAH Analysis for Hot Melt Adhesives 27 Raw materials intended for food contact are listed in Plastics Regulation (EU) No 10/2011 Toxicological evaluations have been carried out At the same time they may appear as MOSH and MOAH in analytical evaluations Today there is no straightforward analytical method to easily distinguish the approved substances from MOSH / MOAH analysis
Food Safe Packaging with H.B. Fuller 28
Food Safe Packaging with H.B. Fuller 29 Careful selection of raw materials according to FEICA guidelines Close cooperation with our suppliers and allied suppliers Investment in migration studies for product and raw material assessments Providing comprehensive food contact declarations to our customers Packaging Material Selection
Collaboration Expertise Adhesives Food Safe Packaging with H.B. Fuller
31 Join the Conversation www.hbfuller.com/connect This presentation is for informational purposes only and does not constitute an offer by H.B. Fuller to sell or a warranty of any kind.
32 IMPORTANT: Information, specifications, procedures and recommendations provided ( information ) are based on our experience and we believe this to be accurate. No representation, guarantee or warranty is made as to the accuracy or completeness of the information or that use of the product will avoid losses or damages or give desired results. It is purchaser s sole responsibility to test and determine the suitability of any product for the intended use. Tests should be repeated if materials or conditions change in any way. No employee, distributor or agent has any right to change these facts and offer a guarantee of performance. NOTE TO USER: by ordering/receiving product you accept the H.B. Fuller General Terms and Conditions of Sale applicable in the region. Please request a copy if you have not received these. These Terms and Conditions contain disclaimers of implied warranties (including but not limited to disclaiming warranties of fitness for a particular purpose) and limits of liability. All other terms are rejected. In any event, (1) the total aggregate liability of H.B. Fuller for any claim or series of related claims however arising, in contract, tort (including negligence), breach of statutory duty, misrepresentation, strict liability or otherwise, is limited to replacement of affected products or refund of the purchase price for affected products. (2) H.B. Fuller shall not be liable for loss of profit, loss of margin, loss of contract, loss of business, loss of goodwill or any indirect or consequential losses arising out of or in connection with product supply. (3) Nothing in any term shall operate to exclude or limit H.B. Fuller s liability for fraud, gross negligence or for death or personal injury caused by negligence, or for breach of any mandatory implied terms unless permitted at law.