Legislation safeguards against plastic monomers and additives contact

The intention of EU food contact materials legislation is to keep food safe and unadulterated by requiring that materials coming into contact with food do not transfer their constituents into food and endanger human health or affect food quality. For plastics this is achieved by ensuring all substances used in food contact plastics is assessed before approval. Andrew Burgess reports.

At the European Union level the first piece of legislation which encompassed food contact plastics was the Framework Directive (89/109/EEC)1. This applied to all food contact materials and laid out the general philosophy for food contact legislation in the EU. The primary aims were to ensure consumer protection and the introduction of harmonised of regulation across EU member states.

The legislation of plastics was developed further by the Specific Directive 90/128/EEC2. and its current seven amendments (recently re-cast as Directive 2002/72/EC3). In these Directives plastic monomers and additives are regulated via lists of approved substances (aPositive' lists). Approval can be conditional with restrictions based largely upon migration (a rate of migration from food contact plastics), and to a lesser extent on composition (a maximum permitted concentration of monomer/additive).

The positive list for authorised plastic monomers is subdivided into two sections: Section A contains monomers which are fully harmonised at the EU level; Section B contains monomers which have been authorised in at least one Member State but are not fully harmonised at the EU level. Section B will be discontinued after 31st December 2004. The list of authorised plastic additives is not yet a positive list (ie additives can therefore continue to be used providing they comply with national legislation). It is scheduled to become a positive list from 1st January 2005 and is also subdivided into two sections: Section A contains additives fully harmonised at the EU level; Section B contains additives not fully harmonised at the EU level.

The starting point when determining whether a plastic additive/monomer is new is to consider whether the intended use falls within the scope of the plastics directive. Directive 90/128/EEC states that the plastics legislation applies to materials and articles made exclusively of plastic which, in their finished state, are intended for use in contact with food. It also applies to materials and articles made of bonded layers of plastic, but not if one or more of the layers are non-plastic. This excludes, for example, plastic coatings on paper or metal cans, which must meet the general requirements of the framework Directive. In Directive 90/128/EEC, aplastics' are broadly defined as organic polymers. Regenerated cellulose film, elastomers and rubber, paper and board, surface coatings containing paraffin or micro-crystalline waxes and ion-exchange resins, however, are excluded from this definition. This is because they have, or will eventually have, their own separate Directives.

Where it is considered that the intended use is within the scope of the Plastics Directive, the current regulatory status of a substance can be determined by consulting the aSynoptic Document' of the European Commission's Joint Research Centre ­ Food Contact Materials Resource Centre (EC JRC)4. Petitions for approval of monomers and additives are initially reviewed by the European Commission's Scientific Committee on Food (SCF). After the SCF have reviewed a petition, their opinion is published on the SCF website5 and added to the Synoptic Document. After listing in the Synoptic Document there The intention of EU food contact materials legislation is to keep food safe and unadulterated by requiring that materials coming into contact with food do not transfer their constituents into food and endanger human health or affect food quality. For plastics this is achieved by ensuring all substances used in food contact plastics is assessed before approval. Andrew Burgess reports.is usually a delay until listing in a Directive. Hence the current Directive listing (in 2002/72/EC) needs to be viewed in conjunction with the Synoptic Document.

In order that a substance be added to, or reclassified in, the listing of the Synoptic Document a petition needs to be submitted to and approved by the SCF.

Main elements of a petition

The main elements of a food contact material petition are: identity; physical and chemical properties; intended use; microbiological properties; other authorisations; migration data; toxicological data.

* Identity: This includes details such as the substance's chemical identity, purity/impurity profile and its breakdown and reaction products.

* Physical and chemical properties: Physical properties such as melting point and decomposition are requested. Some chemical properties including stability to light, heat and moisture and identification of decomposition/transformation products are also requested.

* Intended use: This is a description of the range of conditions to which food contact plastics containing the substance will be subjected. This involves aspects such as the type(s) of plastic the substance will be used in, the intended function of the monomer or additive and the intended exposure time and temperature.

* Microbiological properties: An indication of the biocidal properties (ie whether it has a controlling effect on harmful organisms) is required to investigate whether use of the substance could lead to possible public health implications.

* Other authorisations: If the substance has been approved by other countries food contact schemes details should be provided.

* Migration data: The purpose of migration data is to estimate the maximum daily intake of a substance from food contact materials via ingestion of food. These tests quantify the typical amount of a substance that is anticipated to be transferred from food packaging into food simulants. Migration testing should be conducted under conditions which mimic the intended uses of a substance, in terms of temperature, duration of exposure and food type (eg aqueous, acidic, alcoholic, fatty).

* Toxicological data: These data requirements are based upon the level of migration of a substance into food. In general, the lower the level of migration, the less toxicological data are required to support a petition. Additional data can be required if there are indications (for example from structural alerts or analog compounds) of other adverse toxicological effects (such as endocrine disruption, immunotoxicity, neurotoxicity). The toxicological data supplied should be appropriate to the chemical forms in which a substance or for example its hydrolysis products migrates into food.

The migration levels of a substance into food and the associated toxicological data requirements are as follows:

50 ppb (limited data set); 3 in-vitro mutagenicity studies 50ppb to 5ppm (reduced data set); 3 in-vitro mutagenicity studies; 90 day oral toxicity study; data to demonstrate the absence of potential for accumulation in man >5ppm (core data set); 3 in-vitro mutagenicity studies; 90 day oral toxicity study, normally in two species; studies on absorption, distribution, metabolism and excretion; studies on reproduction (in one species), and developmental toxicity (normally in two species); studies on long-term toxicity/carcinogenicity, normally in two species.

Summary

In the EU, plastic monomers and additives used in food contact materials are assessed to ensure that their intended use does not compromise food safety or lead to adulteration of food. Specific EU directives contain lists of authorised monomers and additives which can be used in food contact plastics. For a new monomer or additive to be added to these authorised lists a comprehensive petition, which adequately addresses any safety concerns, needs to be approved.

enquiry no 62

Andrew Burgess BSc, is Regulatory Affairs Manager, Huntingdon Life Sciences, Huntingdon, UK. www.huntingdon.com

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