Recent Developments in Food Contact Legislation
23 November 2009
Dr Alistair Irvine, Principle Consultant in Food Packaging Safety at Pira International guides us through the recent changes. This article is an updated version of one published in Packaging Professional Magazine on 14th July 2008.
Navigating through constant amendments to European food contact legislation is increasingly challenging for the packaging industry. Since 2007 these have included 3 amendments to the Plastics Directive 2002/72/EC, a regulation covering recycling of plastics for food contact applications; an amendment of the GMP Regulation, 2023/2006, covering the use of inks on food packaging and a new regulation on active and intelligent packaging. These changes are discussed below.
Directive 2007/19/EC - The 4th Amendment to 2002/72/EC
Declaration of Compliance
Most significantly, 2007/19/EC requires a Declaration of Compliance to accompany all food contact plastics. This aims to help packaging manufacturers and users prove the packaging adheres to the legislation.
For a raw material supplier, the Declaration needs to contain enough
information to demonstrate to packaging manufacturers that the materials are approved for use in food contact plastics. It should let them know if there are any additives or monomers present that are subject to specific restriction such as migration limits so that the 'finished article' can be checked.
The Declaration provided by the packaging manufacturer also needs to reassure customers that the finished goods comply with the legislation. Plastics packaging manufacturers should ask their suppliers of plastics, additives and masterbatches for Declarations of Compliance in line with this regulation, check for restricted substances and ensure they meet these limits.
Testing is normally carried out using chromatographic techniques, requiring laboratory skills and food contact experience. Pira can work with you to decide what needs testing and then carry out the agreed programme.
Gaskets in metal lids
In the past, it was unclear whether plastics used in gaskets in metal lids were subject to the same legislation as other food contact plastics. This was clarified by the 4th amendment which stipulates that gaskets are to be treated in the same way as plastics, subject to the same authorisation processes for monomers and additives and to any migration limits that apply.
Additionally, some restrictions on plasticisers that are widely used in these gaskets have been modified. Epoxidised soybean oil (ESBO) now has a tighter specific migration limit when it is in contact with foods intended solely for
children.
Pira has test methods for measuring the specific migration of all gasket plasticisers. These tests can be carried out in food simulants, or in food itself.
Other changes
The 4th amendment contains a number of other changes, namely:
- Incorporation of the monomers and additives evaluated positively by EFSA since the 3rd amendment, Directive 2005/79/EC.
- Acceptance of the functional barrier concept and guidance on how to show that a barrier layer prevents migration. This will help promote the use of recycled materials in non-food contact layers of food packs.
- A fat consumption factor for checking migration of fat-soluble additives into foods and a listing of these additives.
- A new food simulant (50% ethanol) to simulate migration into milk and similar foods.
- A requirement to declare the use of 'dual use' plastics additives.
Directive 2008/39/EC - The 5th Amendment to 2002/72/EC
This sets a timetable for establishing a 'positive list' for additives in food contact plastics. Until recently, it has not been mandatory for additives to be listed, provided they were approved in one of the EU member states. After 1 January 2010, all such additives must be on the positive list. Food packaging manufacturers need to ask their suppliers to confirm their additives are on the provisional list, and, if necessary, switch materials before 2010.
In addition it incorporated the monomers and additives evaluated positively by EFSA since the 4th amendment.
Commission Regulation No 975/2009 - The 6th Amendment to 2002/72/EC
This came into force on 8th November 2009. It is straight forward and merely adds the monomers and additives evaluated positively by EFSA since the 5th amendment.
Other Recent Regulations
These have covered recycled plastics, the safety of printing inks and active and intelligent Packaging.
The EC has published a regulation on the use of recycled plastics, EC Regulation No 282/2008, which allows the European Food Safety Authority to authorise recycling processes and stimulate the use of these materials. It covers quality system requirements, identification of critical control points, an authorisation procedure for recycling processes and the split of responsibilities between process owners and licensees. In addition to this Regulation recycled plastics have to comply with all the requirements of Directive 2002/72/EC as amended. Pira has supported companies through the authorisation procedure and in quality control of recycled plastics in commercial circulation.
For printing inks some general principles have been introduced by the Good Manufacturing Practice Regulation (EC Regulation No 2023/2006). However, it does not contain a framework for risk assessment. A suitable method for this risk assessment is available from the European Printing Ink Association, and, although this has not been translated into formal legislation, Pira can help you make use of this to show that printing inks are safe.
Regulation No 450/2009 lays down additional requirements to those contained in the Framework Regulation, No 1935/2004, for active and intelligent materials and articles to ensure their safe use. It puts in place requirements for:
- A legal framework to establish a positive list of active and intelligent components;
- Biocides that extend shelf life. These are only allowed if they are approved food additives;
- Labeling, which must meet the requirements of Regulation 2004/1935, Directive 79/112/EEC (Framework Directive for Sale of Foods) and Directive 89/109/EEC (Labeling of Food Additives);
- Active packaging must not disguise poor quality food;
- Any substances released must not cause the overall migration limit to be exceeded.
- Active and intelligent systems to be incorporated into the pack structure if possible. However, where an insert is used it should be labeled "DO NOT EAT" and where technically possible carry a symbol reinforcing this message.
New Legislation to Come - The PIM
Early in 2010 all the current legislation on plastics will be replaced with a codified Regulation currently known as the Plastics Implementing Measure (PIM). Information on the extensive changes that this will bring about is contained in Nick Kernoghan's webinar which is also available as a download from our website.