Packaged food has become an indispensable part of daily life in countries of North America, Europe and parts of South East Asia. Changing lifestyles requires food to stay fresh longer, and hence suitable packaging is required to ensure minimum food wastage. Recent developments in active and intelligent packaging show that the packaging plays an active role in giving information on the freshness of the package contents. All these innovations ensure that market for plastics in contact with food continues to grow. In this rapidly developing area, regulations are developing at a similarly rapid pace in the European Union. In the EU, the additional regulatory driver over the past twenty years, has been the need to develop harmonized legislation - the provision of a common set of rules across the EU that will apply in all EU member states, thus removing technical barriers to trade. The European Food Safety Authority (EFSA) has published dates for the closure of its positive list for additives, thus ending the harmonizing process.

For a plastic article to be placed on the EU market for a food contact application, several legislations require consideration.
The first is the "framework" regulation, regulation 2004/1935 : this places the responsibility on the manufacturer of the article to ensure that the article does not transfer its constituents to food in quantities that could (a) endanger human health; or (b) bring about an unacceptable change in the composition of the food; or (c) bring about deterioration in the organoleptic characteristics thereof (Article 3). The regulation does not give directions of how this is to be done but gives a clear requirement on manufacturers to conduct appropriate risk assessments and make considerations of other legislative acts. Though these requirements on food packaging appear obvious, the current 27 EU members represent numerous legal traditions and differing laws who are working to ensure these essential requirements are met.
EU Directive 2002/72/EC is the key legislative act for ascertaining which polymer ingredients can be considered safe. This directive is critical since it gives a maximum level of total migration of monomers and additives and details of allowable monomers (for the production of food contact polymers) and polymer additives and any particular restrictions that are placed on them. These lists are exclusive in that substances not on them cannot be used in the manufacture of food contact plastics (The additives list is currently incomplete in that additives not on the list but approved by individual member states can still be used, although this situation will soon change). The monomer list is a list of authorized monomers and other starting substances for the production of food contact plastics. This means that food contact plastics can only be made from the monomers on this list: the list does not relate in any way to the presence of residual monomers in the final packaging but the monomers and other substances that are used at the start of the polymerization reaction.
Directive 2002/72/EC states that the total level of migration of substances from the plastic article into food shall not exceed 10 mg/square decimeter of surface area of the material or article. This so-called "Global" migration limit refers to all migrating substances and can be expressed in 60 mg of migrating constituents/kg of foodstuffs for containers and other fillable articles and caps, gaskets and stoppers. There are additional directives (Directives 82/711/EEC and 94/62/EC), which give details of the test methods that can be used in the determination of migration. These are normally conducted using water, ethanol, acetic acid or olive oil as food stimulants depending on whether the food in question is of an aqueous, alcoholic, acidic or fatty nature. In some cases the olive oil can be replaced by iso-octanol where the use of olive oil presents analytical difficulties (e.g. absorption of olive oil is greater than the migration into it).

Directive 2002/72/EC can place certain restrictions on approved monomers and additives along with listing monomers and additives to be used in the manufacture of food contact articles. It can place a restriction on the maximum quantity of a substance allowable in an article, or more commonly on the maximum amount of migration of the substance into food. If the manufacturer of a polymer or additive uses a monomer or additive that has such a Specific Migration Limit (SML) they should declare its presence to customers further down the chain unless it can be demonstrated that the migration limit cannot be exceeded. The requirement to verify that the final article complies with any such restriction is on the manufacturer of that article since it is this manufacturer that will be in possession of the full formulation and compositional details of the article. Manufacturers further up the chain can contribute compliance details but will normally place various caveats stating that the requirement for testing is on the article manufacturer and that they can only confirm absence of migration in typical or test formulations and not the final food contact article since they have no control over the composition, thermal treatment or configuration of that article. Directive 2002/72/EC has been amended 4 times and a fifth amendment is expected shortly. These amendments have added approved monomers and additives to the respective lists, removed monomers and additives from provisional list and modified the restrictions on some monomers and additives.

In addition to the above directive there remain various positive lists for polymers and additives in several member states. These still remain in force although member states have now implemented EU Directive 2002/72/EC into their legislature as well. In some cases the implementation has been made as an amendment to the existing national legislation. It needs to be stated that EU Directive 2002/72/EC regulates monomers and additives in food contact articles. As such it does not deal with substances that may be present in food contact articles but do not fall under those two headings. This includes substances such as aids to polymerization, decomposition or reaction products of approved monomers and additives, impurities present in approved substances and bloomers. Substances of these types still need to be considered by the manufacturer of the article and Article 3 of Regulation 2004/1935 still needs to be obeyed. How this is done by differ depending on which type of ingredient is under consideration. For example, aids to polymerization, although not regulated in harmonized legislation, are considered in some Member State legislatures, such as the German Bundesinstitut für Risikobewertung (BfR) and the Dutch Warenwet and Warenwetbesluit. Other tests for very low-level contaminants can include analysis in migration tests. Consideration needs to be given for what are termed Non-Intentionally Added Substances (NIAS). It is difficult to give any indications of how to do this since it will depend on the composition of the article in question and the nature of the substance. However one can refer to the case of the approval of azodicarbonamide (ADC). This was used as a blowing agent for plastic foam systems and was approved for use as a blowing agent in Directive 2002/72/EC. However the detection, in food, of semicarbazide, a breakdown product of ADC, at exceedingly low levels caused a problem inasmuch as the semicarbazide was not on the positive lists and was not well understood toxicologically. As a result, and although EU experts had stated that the risks associated with the presence of semicarbazide at the low levels concerned were exceedingly low, ADC was removed from the positive list of Directive 2002/72/EC and cannot now be used in food contact plastics. Similar situations have occurred with reaction products of Epoxidised soya bean oil resulting in modifications to the SML of this approved additive. As a result attention to NIAS is required in the consideration of proof of compliance with Article 3 of the framework regulation.

There have been some recent additions to the regulations and directives in the area of food contact plastics. Of particular note is a regulation on Good Manufacturing Practice for the manufacture of food contact articles, regulation 2023/2006. This is especially pertinent to the manufacturer of the article although the requirements are placed all the way up the chain as far as, but not including, the manufacturers of starting substances. Among others this includes the requirement for manufacturers of food contact articles to run a well-defined Quality Assurance System.

There are a number of legislative instruments that a producer of food contact articles needs to comply with. As such they also need to ensure that their suppliers of raw materials know and follow these instruments effectively and as such key questions need to be asked of a raw material supplier to ensure that compliance of the manufactured article can be shown, although the article manufacturer may still need to perform specific tests on the article to confirm or ensure compliance.