ADI refers to the “Acceptable Daily Intake” and describes the amount of a substance that any individual can safely consume over a life time without it posing an appreciable/inacceptable health risk. The concept is used for substances such as additives, pesticide residues or veterinary drugs. In the US, the FDA also uses the concept for food contact materials.
Benzophenone (CAS 119-61-9) is an organic compound which is used as a photoinitiator in printing inks applied to food packaging materials. It can also be used as a UV absorber in clear food packaging material, allowing manufacturers to package UV-sensitive food in transparent packaging. Benzophenone was shown to be estrogenically active in an uterotrophic assay.
Bisphenol A (BPA) (CAS 88-05-7) is an organic compound which is used in epoxy resins, printing inks, coatings of paper and board and as a monomer in poly carbonate plastics. The substance has raised concerns because it exhibits hormone like activity and has been associated with various chronic diseases, such as asthma, obesity and heart disease. In the EU, China, USA, Canada, South Africa and the United Emirates BPA is banned from the use in the manufacture of infant feeding bottles.
CEDI stands for “Cumulative Estimated Daily Intake”. It is a concept used by the FDA to model total estimated daily intakes of all regulated, notified and exempted uses of a food contact substances. The FDA’s model is based of food consumption modeling.
Ceramics are crystalline materials based on inorganic, nonmetallic solids. An example of ceramics is pottery.
EDI stands for “Estimated Daily Intake” and is the estimate of the daily intake of a substance based on an estimation of residues of those substances found in food and food consumption data. It is used by the U.S FDA.
EFSA is the European Food and Safety Authority responsible for food contact materials (see EFSA webpage).
Endocrine Disrupting Chemicals (EDCs)
The definition most accepted amongst regulators and risk managers is that an Endocrine Disrupting Chemical is an exogenous substance or mixture
that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, its progeny, or (sub)population” (WHO, 2002).
According to the Endocrine Society EDCs are exogenous chemicals, which interfere with any aspect of hormone action (see Zoeller et al. 2012). This definition is most prominently used by scientists. Other definitions exist.
The U.S. American Food and Drug Administration is responsible for authorizing the use of substances in food contact materials and drugs as well as for the enforcement of regulations related to food contact materials.
Food Contact Materials
Food contact materials include food packaging as well as processing equipment, storage containers, machinery and kitchen ware which are intended for food contact.
Glass is an amorphous material mainly made of silica (SiO2), soda ash (Na2CO3) and lime stone (CaCO3). It can be used to package food stuff.
GRAS is an acronym for “Generally Recognized As Safe”. In U.S.-legislation the term refers to a substance that does not require authorization in order to be used in food contact materials. A substance can acquire GRAS status if one toxicological assessment in accordance with the food additive regulation has been carried out and published, which does not show any adverse effects. This study can also be carried out by the manufacturer himself, and is therefore sometimes termed “self-affirmed” GRAS status. Once a substance has acquired GRAS status, the company using the substance is no longer required to notify the FDA of its use and the level of assumed exposure to individuals (see FDA).
ITX stands for isopropylthioxanthone and is used as a photoinitiator in offset printing inks. It has also been measured in food stuffs.
LOAEL stands for “lowest observed adverse effect level” and is the lowest dose at which a substance has been tested toxicologically and shown a relevant effect.
Low dose may either refer to doses at typical human exposures or to doses below dose typically tested according to toxicological testing protocols. It may also refer to doses below those at which a biologically change in animals is observed (below the LOAEL or NOAEL) or to doses which produce similar blood levels in animals to those measured in the humans population (averages).
A metabolite is a product of metabolism. Metabolites are often used as indirect markers for the exposure to a substance. As such, cotinine may be measured as a biomarker of tobacco smoke. The primary site for the metabolism of environmental chemicals is often the liver, depending on the exposure route.
Migration in food safety usually refers to the process whereby substances from the packaging material diffuse into the food stuff. However, it can also refer to the diffusion process from outside of the direct food contact layer through the packaging material into the food stuff.
Mineral Oils (MOH) are hydrocarbon chains with 14 to 40 carbon groups, which are usually based on petroleum distillates. Most attention has been drawn to Mineral Oil Aromatic Hydrocarbons (MOAH) which are suspected to be carcinogenic. Whereas MOH consist of linear and branched alkanes, MOAH consist mainly of alkyl-substituted polyaromatic hydrocarbons. Mineral Oil Saturated Hydrocarbons (MOSH) in the range of C16 to C35 are lipophilic and likely to accumulate in human fatty tissue; they may cause microgranulomas in several tissues including lymph nodes, spleen and liver (EFSA opinion).
NIAS stands for “Non-Intentionally Added Substances” and refers to substances that may be present in food contact materials as byproducts, impurities, or brake-down products of the food contact material manufacturing process.
NOAEL stands for “no observed adverse effect level” and usually refers to the last dose tested below the LOAEL at which no significant adverse effect was observed.
Traditional toxicology assumes the dose-response curve to be monotonic. A non-monotonic dose-response curve changes sign at least once. Such dose-responses have been observed for hormones and endocrine disrupting chemicals. They question applicability of traditional risk assessment approaches for EDCs and are being discussed controversially (see FPF article on endocrine disruptors).
Packaging is used to protect food and increase shelflife. It may also fulfill technical requirements and marketing needs (consumer information).
Paper is a cellulose pulp derived thin material used amongst others for the packaging of food stuff.
Perfluorooctonic acid (PFOA) is a perfluorinated alkyl acid. PFOA consists of a carboxyl group with an 8 carbon alkyl chain that is fully substituted with fluor. PFOA is a biotranformation product of polyfluoroalkyl phosphoric acid diesters (diPAPs), which are used as grease repellants in food contact materials. The PFOA stewardship program of the US EPA aims to eliminate PFOA from consumer products by 2015. After a report was published in 2012 by the US FDA reviewing the health effects of PFOA, BASF, DuPont and ClariantCorporation committed to voluntarily withdraw PFOA.
Perfluorooctonic sulfonic acid (PFOS) is a perfluorinated alkyl acid. PFOS consists of a sulfur group with an 8 carbon alkyl chain that is fully substituted with fluor. PFOS is listed as a persistent organic pollutant (POP) in Annex B of the Stockholm Convention due to its environmental persistence and potential to bioaccumulate.
Phthalates are esters of phthalic acid and are used as plasticizers in polymer materials. They are being phased out in many countries due to health concerns (for more see article on phthalates on the FPF webpage).
Plastic materials are moldable polymer based materials of high molecular mass. They are traditionally made of petrochemicals, but may also consist of natural materials (bioplastics). Plastics are widely used to package food.
POP stands for persistent organic pollutant and refers to chemicals which have been identified under the Stockholm Convention on Persistent Organic Pollutants. The Convention, which came into effect in 2004, defines POPs as “chemical substances that persist in the environment, bio-accumulate through the food web, and pose a risk of causing adverse effects to human health and the environment”. Currently 18 chemicals are listed, including perfluorooctonic sulfonic acid (PFOS) which has been ubiquitously measured in human blood serum samples. The last modification was made in 2011 adding endosulfan and its isomers to the list.
European Registration, Evaluation, Authorisation and Restriction ofChemical substances (REACH) is the European Community Regulation on chemicals and their safe use (EC 1907/2006). It entered into force in 2007 and regulates the testing of commercially used chemicals. The regulation requires manufacturers to submit a technical dossier for substances produced in quantities of 1 ton and a chemical safety report (CSR) for chemicals produced in quantities exceeding 10 tons. Pre-registration was completed in December 2009 and substances produced in quantities exceeding 1000 tons had to be registered by 2010. The full registration process is scheduled for completion in 2018 (for more see EU REACH). The regulation is enforced by the European Chemical Agency (ECHA).
Risk Assessment is a process by which the risk involved in a certain decision (such as the use of a certain substance) is evaluated. The process is subdivided into Hazard Identification, Exposure Assessment, Dose-Response Assessment and Risk Characterization.
Sensitive windows are those windows in development in which humans are particularly vulnerable to environmental interference, may it be chemical, psychological, or other events. The term ‘sensitive windows’ usually refers to fetal and early infant development (see PPTOX II consensus paper).
Set-off migration refers to the transfer of chemicals from the outer surface of a packaging material onto the food contact surface. Set-off migration typically occurs during stacking and rolling of packaging materials prior to the packaging of food within. Components of printing inks, but also outer coatings not intended for food contact may consequently contaminate the food stuff.
Specific Migration Limit
The Specific Migration Limit (SML) specifies a level above which a substance may not migrate into food. It is set by the European Commission and given in mg/kg food. The SML is based on the tolerable daily intake (TDI), which is derived from toxicological data. For some substances the European Commission has set group SMLs. Group SMLs apply to groups of substances considered to act through similar pathways.
TDI stands for “Tolerable Daily Intake” and is the estimate of the quantity of a substance that can be consumed over a lifetime without appreciable health risks. TDIs are calculated for contaminants on the basis of toxicological test.
Threshold of Toxicological Concern
The Threshold of Toxicological Concern (TTC) concept is used to define human exposure threshold values for substances for which no specific toxicity data exists. Below the TTC, a substance has a very low probability of causing adverse health effects. Substances are evaluated based on structural properties and toxicity data of compounds with similar two-dimensional chemical structures. The concept is only applicable if a chemical’s structure and exposure data are known and if none of the exclusion criteria, such as genotoxicity or bioaccumulative potential, are fulfilled.