New EU Legislation on Food-Contact Plastics Enacted; Significant Changes on the Horizon
A new regulation that will consolidate all previous directives and regulations on plastic food-contact materials, and implement some significant changes, was recently enacted in the European Union (EU). Regulation (EU) No 10/2011 on Plastic Materials and Articles Intended to Come into Contact with Food—commonly referred to as the Plastics Implementing Measure (PIM)—was published in the Official Journal of the European Union on January 15, 2011 and came into force on February 4, 2011. As of May 1, 2011, the PIM will replace the Plastics Directive (2002/72/EC) and its amendments, as well as various directives on compliance (migration) testing. Unlike the Plastics Directive, which required transposition into the national laws of the individual Member States, the PIM is a regulation, and is directly applicable in all of the EU Member States as of May 1, 2011. Nonetheless, because certain changes to the existing food-contact legislation on plastics cannot be implemented overnight, the PIM phases in some of the more significant changes over a period of several years.
The European Commission (EC) began working on replacing the Plastics Directive with a regulation that would be directly applicable in all of the EU Member States in 2004. In addition to consolidating all of the EU directives on plastic food-contact materials, the PIM was developed with the intention of presenting the rules in a clearer and more concise way, deleting redundant and outdated provisions, and updating technical rules based on scientific advances. Of course, with the introduction of numerous substantive changes, as well as modifications to the migration testing scheme, the PIM goes well beyond the original goals.
One significant change brought about by the PIM is the expansion of the plastics legislation to include plastic layers in so-called "multi-material" articles. These are articles that are comprised of more than one type of substrate (e.g., articles with plastic and metal layers, articles with paper and plastic layers, etc.). Under the Plastics Directive, only plastic articles, or multi-layer articles comprised entirely of plastic, were regulated. Under the PIM, plastic layers in multi-material articles are required to comply compositionally with the positive list of substances permitted for use in plastics (unless they are eligible for exemption under the "functional barrier" provision). However, they are not required to meet overall migration limits (OMLs) or specific migration limits (SMLs) set forth in the regulation, except for those applicable to vinyl chloride monomer.
The PIM also introduces several new definitions related to plastic food-contact materials and expands the scope of several others. For example, although the term "non-intentionally added substance" (NIAS) has been used for a number of years in the EU to generically describe impurities, it was not previously defined. The PIM now provides a definition for NIAS, and specifies the need to address the safety of NIAS. In addition, under the Plastics Directive, additives were limited to those substances intended to achieve a technical effect in the finished product, whereas under the PIM, an expanded definition includes substances intended to achieve a physical or chemical effect during processing. Similarly, while polymer production aids were included in the definition of additives under the Plastics Directive (although they were not subject to positive list requirements), they are defined separately under the PIM.
The two separate lists of permitted additives and monomers in the Plastics Directive are consolidated into a single list in the PIM. This list of permitted substances includes columns that indicate whether or not the substance is authorized as an additive or polymer production aid (PPA) and/or as a monomer (starting substance). Also, the list is now organized by newly-assigned "FCM substance No.," rather than by Ref. No. (though these still appear in each entry).
The Commission has also taken this opportunity to expand the list of metal salts that are authorized under the positive list. More specifically, both the Plastics Directive and PIM permit the use of certain metal salts of authorized acids, phenols, or alcohols. The PIM expands the list of metal salts to include barium, cobalt, copper, lithium, and manganese.
With regard to nanotechnology, the PIM prohibits the use of nanoform substances that are not specifically authorized in nanoform. Hence, nanoform substances will not be covered by listings for conventional forms of the same substances. Likewise, substances in nanoform are not eligible for exemption under the functional barrier doctrine, which allows the use of substances not listed on the PIM (except for vinyl chloride monomer) provided that they: are separated from food by a barrier; migrate at a level of less than 10 parts per billion (ppb); and are not carcinogenic, mutagenic or toxic to reproduction.
Other changes impact additives used for glass fibers, as well as additives in plastic layers or coatings forming gaskets in caps and closures. Although glass fibers have been permitted as plastic additives for some time, the Plastics Directive does not address the sizing agents that are used to make glass fibers compatible with plastics. Hence, such additives have been deemed by many in industry as not regulated by the Plastics Directive. However, beginning January 1, 2016, additives used in glass fiber sizing for glass fiber reinforced plastics will be required to be listed on the PIM. With regard to additives used in plastic layers or coatings forming gaskets on lids (that together are composed of two or more layers of different types of materials), these were not required to be listed on the Plastics Directive. By contrast, beginning January 1, 2016, additives, other than plasticizers, used in plastic layers or coatings in caps and closures will be subject to the positive list requirements of the PIM.
The PIM includes substantial changes to the testing conditions used to simulate potential migration of authorized substances to food. First, by way of background, it is important to note that the existing legislation (Directive 82/711/EEC) provides only one testing scheme to be used for purposes of verifying compliance with both the specific migration limits (SMLs) and overall migration limit (OML). In other words, to cover a given time/temperature application, the same testing conditions would be used for purposes of SML and OML testing. Under the PIM, however, the previous scheme has been substantially modified, and is only applicable to SML testing; an entirely separate (and new) testing scheme is introduced for OML testing.
The most significant changes to the SML testing conditions are seen for long-term, room temperature storage applications. For example, the time/temperature conditions for simulating long-term storage have been increased from the current 10 days at 40ºC to the following: 10 days at 50ºC for storage at room temperature for up to 6 months, or 10 days at 60ºC for storage at room temperature for over 6 months. However, there are still instances where 10 days at 40ºC can be used, such as where there is scientific evidence that migration of the analyte has reached equilibrium under this test condition.
The OML test conditions are entirely new, and are grouped using the designations OM1 through OM7. These test conditions are described in detail in Annex V, Chapter 3, Table 3 of the PIM. Because the test conditions differ from the SML test conditions, it is important to note that one set of test conditions may not suffice for purposes of establishing SML and OML compliance. Further, Article 11 of the PIM adds a new "SML" requirement, indicating that a generic default SML of 60 mg/kg will apply to those substances for which an SML (or similar limitation) is not specified. Thus, even if a substance is listed in the PIM without an applicable SML, Article 11 suggests that SML and OML testing would be necessary to establish compliance of the finished article with the PIM.
In addition, the specified food simulants, applicable to both testing schemes, have been modified. For example, the default simulant for non-acidic, non-alcoholic foods changes from water to 10% ethanol. Likewise, the simulant for alcoholic foods containing up to 20% alcohol is 20% ethanol, while the simulant for dairy, cloudy, and high-alcohol beverages is 50% ethanol. With regard to fatty foods, for which olive oil is currently used as the simulant, the new simulant is vegetable oil (meeting certain specifications). The simulant for acidic foods remains as 3% acetic acid. Finally, the PIM introduces a new dry food simulant – poly(2,6-diphenyl-p-phenylene oxide), commonly known as Tenax – for use in SML testing only.
These changes will not only impact companies seeking new clearances under the PIM, but will, in most cases, require the retesting of products that are already on the market in the EU.
Taking into account the additional time that will be needed for industry to establish compliance under the new requirements (particularly the testing requirements), implementation of certain provisions of the PIM is staggered over several years. Thus, in addition to the January 1, 2016 implementation date for the provisions related to glass fiber sizing agent additives and additives used in plastic gaskets, the PIM also creates a maze of transitional provisions for compliance testing. The impact of these provisions can be summarized as follows:
Until December 31, 2012, compliance documents should be based on migration testing using:
- Currently authorized food simulants (i.e., the food simulants specified in 85/572/EEC)
- Currently authorized test conditions (i.e., the test conditions specified in 82/711/EEC)
From January 1, 2013 to December 31, 2015, compliance documents should be based on migration testing using:
- Currently authorized food simulants OR food simulants established in the PIM
- Currently authorized test conditions OR test conditions established in the PIM
Beginning January 1, 2016, compliance documents should be based on migration testing using:
- Food simulants established in the PIM
- Test conditions established in the PIM