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....

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

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...

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...

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...

Improving the safety of rubber as a food contact material

Nitrosamines form as a result of the reaction of nitrosating agents with secondary amines in the rubber. One of the main sources of secondary amines is a number of the accelerators that are used in sulphur-based cure systems, the amines being breakdown products produced as a result of the chemical reactions taking place during vulcanisation. Specific examples of these accelerators, their secondary amine products i.e. the nitrosatable compounds and the nitrosamines derived from them, are given...

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...

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...

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 ,...

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...

Properties and composition of plastic FCMs

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...