Sources of further information and advice

FDA webpage on indirect food additives at http vm.cfsan.fda.gov lrd foodadd.html Community Reference Laboratory for Food Contact Materials. Website at http crl-fcm.jrc.it Food Chemical Safety. Volume 1 Contaminants. D. H. Watson (editor), Woodhead Publishing Ltd, Cambridge, UK and CRC Press, Boca Raton, USA, 2001. ISBN 1-85573-462-1. Migration from Food Contact Materials. L. L. Katan (editor), Blackie Academic and Professional, Glasgow, UK, 1996. ISBN 0-7514-0237-0. Food Packaging Ensuring the...

Regulatory framework for food contact materials in the United States

Within the FDA's Center for Food Safety and Applied Nutrition, the Office of Food Additive Safety administers premarket approval processes for new direct food additives and food additives that are components of food contact materials. Most food contact materials are regulated via the food contact notification process and authorization of new food contact materials is administered by the Division of Food Contact Notifications (see Chapter 2 for further information). The notifier has the primary...

Regulatory authority

Two acts are pertinent to any discussion regarding the regulation of food contact materials in the US. These are the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FFDCA) and the National Environmental Policy Act (NEPA) of 1969. A brief discussion of the authority granted the Food and Drug Administration (FDA) under each follows. The US Congress granted authority to the FDA to regulate food additives in the 1958 Food Additives Amendment to the FFDCA. A food additive...

Other materials

Not only for plastics but also for some other materials specific Community legislation exists, namely Ceramics and Regenerated Cellulose Film (Cellophane, RCF). For rubber teats and soothers migration of nitrosamines is regulated. For coated materials, plastics and adhesives the substances BADGE, BFDGE and NOGE are regulated. No specific Community legislation exists yet for active and intelligent materials but some general rules for those materials are laid down in the Framework Regulation....

Obtaining concentration data 651 Introduction

The actual concentrations of any substance migrating from the packaging into each and every foodstuff are uncertain. In order to evaluate the exposure to any substance, it is necessary to determine the amount of each and every foodstuff consumed, which may have been in contact with the substance, and the concentration of the substance in each and every foodstuff consumed. Surveillance surveys do not measure the concentration of a substance in every foodstuff, but are typically more targeted...

Nordic Report On Legislative Aspects On Active And Intelligent Packaging

FAIR-Project PL 98-4170. 'Actipak' Evaluating safety, effectiveness, economic-environmental impact and consumer acceptance of active and intelligent packaging. Duration 1998-2001. Final report 2003. 2. Council Directive of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (89 109 EEC). Official Journal, L 040, 11 02 1989, 0038-0044. 3. Regulation (EC) No 1935 2004 of the European Parliament and...

Chemical migration from secondary packaging materials

Broacade Gen Architecture

Transfer of substances from secondary packaging to foods can be considered to take place by two main routes. The first is via direct contact where the secondary packaging material directly contacts primary packaging material. Depending on the nature of the substance and the primary packaging material, there may be partition of the substance from the secondary packaging into the primary packaging and then diffusion through the primary packaging material to the packaged food. This obviously...

Safety assessment of carcinogenic constituents of food additives

As stated above, identification of the best analog(s) is done on a case-by-case basis. From a pool of potential analogs with available data, the nearest analogs are generally considered the most appropriate. An exception might be to choose a less-near analog with high carcinogenic potency, to be more protective. For low proposed exposures when a rapid assessment would be adequate to demonstrate safety, FDA may summarily review the bioassay data for the analogs. In some cases, the CPDB is useful...

Who and what should be considered in any exposure assessment

Exposure to a given amount of a given contaminant may not present an issue for one individual, but may be a serious issue for another. Thus the questions, which must be considered in any exposure assessment, include the sensitivity of the individual, in the sense that an infant has a much lower body weight than the conventional assumption used in the EU that a person weighs 60 kg. Also a child, whilst having a lower body weight, consumes a relatively higher proportion of foodstuffs kg of body...

Structure activity relationship SAR analysis in the safety assessment of constituents of food additives

Because of the typically low consumer exposure to constituents of food contact materials, there may be little toxicity testing data publicly available. In such cases, there are a number of methods available to notifiers to address toxicology data gaps, and allow an adequate evaluation of chemicals and the potential risks to a human being exposed to these chemicals. These methods include (i) animal testing, which involves significant time and monetary resources, (ii) in vitro testing, which is...

Sources of further information and advice 691 Further reading for modelling migrants

Brandsch J., Mercea P., Ruter M., Tosa V., Piringer O. (2002), Migration modelling as a tool for quality assurance of food packaging, Food Additives and Contaminants, 19, pp 29-41. O'Brien A., Cooper I., (2002), Practical experience in the use of additive models to predict migration of additives from food contact polymers, Food Additives and Contaminants, 19, pp 56-62. Reynier A., Dole P., Feigenbaum A., (2002), Integrated approach of migration prediction using numerical modelling associated to...

References

Mintel market research report Crisps and Snacks - UK - May 2005. 3. Investigation of chemical migration into take-away and snack foods. E. Bradley and L. Castle, CSL Report FD 03 09, 2003. 4. A study of the potential for chemical migration from packaging used for 'take-away' food and drink. L. Castle and M. Philo, CSL Report FD 00 42, 2001. 5. Regulation (EC) No 1935 2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact...

Qualitative SAR analysis of food additives and constituents

Based on the available historical data, FDA considers carcinogenicity to be the pivotal endpoint of concern for consumer exposures below 150 mg p d, exposure levels typically encountered from food contact material uses. FDA's approach to qualitative SAR is to perform a preliminary 'first look' for structural alerts (SAs) and for close analogy to known carcinogens (Bailey et al., 2005). A useful tool for this type of analysis is the Ashby and Tennant (1991) classification scheme for SAs and a...

Introduction

A fundamental principle of toxicology is that any biological effects increase as the dose increases, in other words 'the dose makes the poison', the often-stated phrase normally attributed to Paracelsus (1493-1541). This philosophy may seem, to some, to be lacking today in the EU, where migrants from food packaging are concerned. The rapid advances in analytical techniques and equipment over the last two decades have resulted in detection limits for known substances migrating being...

Estimating exposure to migrants from food contact articles

The percentile of the population to consider and any at risk or vulnerable groups in an exposure assessment was discussed in section 6.3. Today there is no universally recognised single approach to estimating exposure, particularly to migrants from food packaging. ILSI (2002) undertook a workshop focused on determining exposure to migrants from food contact materials, but a standardised approach or methodology was never agreed however, the need for more data was identified. Exposure assessments...

Conclusions

There is a wide variety of different in-vitro tests that could be applied to extracts of food contact paper and board. However, there are few published reports of their use for this purpose, and at present it is not possible to form a consistent picture of their general applicability. The outcomes of the three most comprehensive studies published so far (Fauris et al., 1998 Binderup et al., 2002 Ozaki et al., 2004) illustrate this point. While all studies agree that the toxicity is correlated...

Chemical migration and the main factors that control it 121 The mechanistic basis of migration

Migration of chemical substances is a diffusion process subject to both kinetic and thermodynamic control and can be described by diffusion mathematics derived from Fick's Law. The mathematics describe the diffusion process as a function of time, temperature, thickness of the material, amount of chemical in the material, partition coefficient and distribution coefficient. The kinetic dimension of migration dictates how fast the process of migration occurs. The thermodynamic dimension dictates...

Chemical migration

As for all food contact materials, chemical migration from materials and articles which come into contact with snack and take-away foods occurs as a result of diffusion processes that are subject to both kinetic and thermodynamic Table 19.2 Materials used to package take-away foods3'4 Meat pie vegetable pie sausage and chips Burgers (beef, chicken and vegetarian) Description of the packaging materials identified for each takeaway food type Grease-proof paper Expanded polystyrene tray Paper bag...

Regulation of active and intelligent packaging 1731 Regulation EC No 19352004

Procedure Intelligent Packaging

In 2004 a new framework Regulation EC No 1935 20043 applicable to all materials intended to come into contact with foods was accepted. In this regulation, general requirements applicable to all food contact materials FCM are established. Specific provisions are included to allow the use of active and intelligent materials and articles, and a specific measure on active and intelligent materials was announced. In order to define the scope of active and intelligent packaging, the following...

Use of functional barriers

Instead of using 'super-clean' recycling technologies which remove, or reduce substantially, the amount of post-consumer compounds and contaminants in the polymer down to similar levels to those in virgin polymers, so-called functional barrier packaging systems can also be efficiently applied to achieve the same effect. No or only negligibly low migration levels of any unwanted foreign compounds can be achieved. A functional barrier can be generally defined as a package construction that limits...

Assessing the safety of rubber as a food contact material

The aim of overall migration tests is to determine if a rubber is suitable for a particular food contact application. The methodology of the test varies depending on the regulations being addressed as does the way of expressing the data and the limits that have to be met. Some of the practical details to the different methodologies are given in section 12.3. A brief review of the tests used in the various regulations is given below. Test pieces are cut from the rubber test product to provide a...

Pivotal and emerging issues in FDAs approach to safety assessment

Exposure estimates, developed from migrant levels in food and information on food contact uses, determine the amount of toxicological information needed to support the proposed use of an FCS. Limitations on use conditions may be imposed by the notifier, possibly at the suggestion of FDA, to reduce exposure to either the FCS or to a constituent due to safety concerns identified during the review. This approach can be advantageous to the notifier. For example, if the available toxicological...

Special considerations for using recycled materials as food contact materials

It is well known from diffusion theory that different types of polymers have different diffusion behaviours. For example, the polyester type polymers like poly ethylene terephthalate PET , poly ethylene naphthalate PEN and polycarbonate PC as well as rigid poly vinyl chloride PVC , which have a high glass transition temperature, are low diffusive polymers. The migration of potential contaminants in these polymers will result in low migration values. In contrast, polyolefins like high density...

Regulation and the use of multilayer packaging

European Commission Directive 2002 72 EC, as amended, relating to plastic materials and articles intended to come into contact with foodstuffs covers multi-layer materials comprising two or more layers each consisting exclusively of plastics, which are bound together by means of adhesives or by any other means EC 2002 . The conventional overall migration limit OML and specific migration limits SMLs given in this Directive apply to these materials. Substances for which SMLs are given include...

Threshold approaches to safety assessment

Historically, toxicity testing and evaluation schemes have always implicitly included thresholds to prioritize concern or delineate the toxicity testing needed to reach a safety decision. In most cases, such thresholds for testing have been qualitatively based on a general knowledge of a chemical or class of chemicals. Moreover, decisions regarding testing recommendations typically weigh the two main factors of the safety assessment paradigm the likely consumer exposure to a particular chemical...

Chemical migration from food packaging adhesives

In most cases an adhesive is not simply composed of the high molecular weight 'gummy' materials discussed in section 14.2 but it also contains additives which provide specific characteristics. A variety of additive types may be used, including carriers water or organic solvents , plasticisers, tackifiers, thickeners and fillers, surfactants, biocides and fungicides, catalysts, pH adjusters, emulsifiers, waxes and antioxidants. Adhesives by their 'gummy' nature are difficult to clean up. This is...

Solutions of the diffusion equation

For interactions between packaging and product the above descriptions of both material transport processes by diffusion and convection as well as the simultaneous chemical reactions come into consideration. The general transport equation 8.6 is the starting point for solutions of all specific cases occurring in practice. Material loss through poorly sealed regions in the package can be considered as convection currents and or treated as diffusion in the gas phase. A solution of the general...

Degradation products and impurities

Dltdp Machanism

Other substances may be present in food contact plastics that were not originally intended to be present in the finished material or article, but arise from reactions during polymerisation or processing. Or they may be present as Table 10.5 Substances commonly used in the manufacture of PET PEN Table 10.5 Substances commonly used in the manufacture of PET PEN T total migration of two or more moieties. T total migration of two or more moieties. impurities in one of the starting substances or...

References and bibliography

Barlow s, 2005 , Threshold of toxicological concern TTC a tool for assessing substances of unknown toxicity present in the diet, ILSI Monograph 2005. benfort d.j., tennant d.r., 1997 , Food chemical risk assessment. Tennant D.R., ed. Food Chemical Risk Analysis, Blackie Academic amp Professional Chapman amp Hall pp 21-56. bouma K., STAVENGA k., draaijer a., August 2003 , Domestic use of food packaging materials in the Netherlands. Report NDFCM 010 01. Available http www.vwa.nl castle l., 2004 ,...

Conventional experimental compliance testing

Conventional compliance testing of food contact materials simulates food contact by bringing food contact materials into contact with a food simulant using certain temperature and time conditions . It then determines what is migrating from the food contact material to the food by testing how much in total migrates overall migration . For some chemical components specific migration or residual content must be performed. Furthermore, additional experiments like sensory evaluation, purity of...

Special considerations of using metals as FCMs

As with all food packaging, the control of migration, regulatory compliance and safety of the finished product is a combination of the intrinsic properties of the packaging and its appropriate use. In some cases, the use of the wrong specification for a particular food product or process may render a potentially compliant package non-compliant. This potential issue is not restricted to the control of migration. As already discussed, the safety of the foodstuff as consumed must also take into...

Administrative compliance evaluation

The principle of administrative evaluation is simple information is requested on how the food contact material is produced this information is compared with relevant legislation and relevant tests are selected. The reality is far from simple. As can be seen from Fig. 5.1 the person who brings the food contact material in contact with the food can be many steps remote from the person who knows the exact composition of the food contact material. In the example in Fig. 5.1 a common situation is...

Quantitative Sar Qsar analysis in the safety assessment of constituents

If the available genetic toxicity data, or the qualitative SAR analysis, indicate potential concern for the carcinogenicity of a constituent, QSAR may be a feasible approach to safety assessment by estimating a worst-case LCR Bailey et al., 2005 . Analog identification is an empirical case-by-case process that uses overlapping approaches to identify structurally and physicochemically related groups of analogs. Historically, analogs have been identified by experience and searching of the...

Properties and composition of plastic FCMs

Tactitle Pie Chart

Plastics can be placed into two main categories, thermoplastic and thermoset. Thermoset plastics are irreversibly formed into a permanent shape often by applying heat. Thermosets cannot be softened and remoulded on heating and have few applications in food packaging, except for the inner linings used for can coatings and many adhesives, as used, for example, in multilayer materials. A limited range of food contact materials is made from thermosets, predominantly melamine resins and unsaturated...

Regulation and use of metals as food contact materials

In general, the existing regulation of metal packaging covers the metallic and non-metallic components of the package separately. In the EU, where there is currently no harmonised specific regulation of metal foodstuff packaging, all components are covered primarily by the Framework Regulation 1935 2004 but it is expected that when harmonised legislation is extended to metal foodstuff packaging, metallic and non-metallic components will be treated separately. In the absence of harmonised EU...

Testing plastics materials for compliance with EU directives

Food Package Testing Methods

EU legislation covering plastics food contact materials is well advanced with a positive list for monomers complete and a positive list for additives near completion. Decisions on how other substances used in plastics, such as aids to polymerisation and colourants are to be regulated, if at all, have yet to be made. Plastics used in contact with food must comply with the Framework Regulation,1 which lays down the basic rules Materials and articles in contact with food shall be manufactured in...

Carcinogenicity risk assessment for constituents of food additives

As discussed above, the Delaney clause applies to substances proposed for use as food additives, but does not apply to individual constituents of a food additive. Examples of constituents would include residual monomers or catalysts. The constituents policy, subjected to judicial review in Scott v. FDA, 728 F. 2d 322 6th cir. 1984 , states that FDA may consider the potential risks of constituent exposure under the general safety standards set forth in FFDCA. The notification process places the...

Industrial guidelines for traceability of materials and articles for food contact

4.3.1 Objectives and contributors to the guidelines As already highlighted in the previous section, the associations representing the food contact materials and articles industries have been requested by the Commission to develop guidelines that would help the industry to harmonise the procedures adopted to achieve the objective set forth by Article 17 of Regulation 1935 2004 EC. These Guidelines have been prepared by a team representing virtually all the food contact materials industries the...

Key scientific advances achieved and needed

In outlining recent key scientific advances, it is in fact sobering to realise just how slow and hard-won some scientific advances have been. Looking back more than 25 years ago to a seminal meeting, the papers presented at the International Symposium on Migration held in Hamburg in 1980 are listed in Table 1.2. The chapters of this book reveal that many of the topics Table 1.2 Topics covered in the 1980 Hamburg symposium The diffusion mechanism of migration of low molecular weight Mathematical...