FINAT, in a collaborative effort with its member UPM Raflatac EMEA, reports on the new EU 10/2011 regulation. This regulation on plastic materials and articles intended to come into contact with food was signed into law on January 1, 2013. It replaces Commission Directive 2002/72/EC and national legislation based on that directive. Its purpose is to support brand owners’ and retailers’ duty of care to their customers, and represents an important additional measure in ongoing endeavors to ensure the quality and safety of food. Label printers who supply to the EU food industry have a key role to play.  

Direct and indirect food contact
The new regulation applies the same principles as EC No 1935/2004 for materials and articles intended to come into contact with food. Such materials are required to be sufficiently inert to not transfer their constituents to food in quantities large enough to endanger human health, and to prevent unwanted changes to the composition of the food and how it looks, tastes or smells.  While EC No 1935/2004 applies to food packaging in general, the new EU 10/2011 specifically concerns all plastic materials and articles intended to come into contact with foodstuff, with labels considered an integral part of such packaging. EU10/2011 consolidates 2002/72/EC and seven amendments (these were previous regulations for plastics).The idea of the regulation is to harmonize the different legislation that has existed previously within individual member states. This should make it easier for different countries to deal with each other in terms of the shipping of goods.

Both direct food contact labels furnished with a plastic layer, as well as plastic labels applied to food packaging,  now require Declarations of Conformity (DoCs) stating which controlled but authorized substances are present in their make-up.

Only when the packaging material or any layer provides a functional barrier that prevents migration of substances from behind that barrier into food, are labels and other packaging components exempt from EU 10/2011. Material compositions that are purely combinations of paper and board continue to be covered by national legislation or recommendations such as those of the German BfR.  

Restricted and unrestricted substances
All authorized substances – both restricted and unrestricted — which may be used in packaging containing plastic in its layers are stipulated on the ‘Union List’ within EU 10/2011. Only  restricted substances need to be declared;  and as DoCs move downstream within the supply/manufacturing chain, such substances must be clearly identified and documented so that compliance can be optimally tested.

Final responsibility for conformance lies with the end user
It is the end user — packager or brand owner – who has final responsibility for checking that the packaging as a whole conforms to EU 10/2011 (in addition to any extant national legislation for papers, as well as to EC 1935/2004, the Framework regulation for all packaging materials), taking into account  the nature of the packaged food, its defined shelf life, and ambient conditions. Label printers are therefore required to provide DoCs for their labels to enable tests for restricted substance levels and migration behavior in specific environmental conditions to be carried out.  

Label printers:  responsibilities and risks
Food label printers supplying into the EU therefore need to be provided with DoCs both from their labelstock and ink suppliers to be able to compile their own DoCs, which must, of course, also incorporate conformance information about any curing processes used during label production.  

It should be noted that the enactment of these regulations means that printers unable to supply DoCs cannot now be accepted as part of the end user’s supply chain, and may also leave themselves open to the financial repercussions of a product recall.    It is therefore essential for label printers to be proactive in obtaining and supplying the necessary documentation if they are to retain their place as responsible and viable links in the broader professional packaging chain. 

The benefits of a secure supply chain
Finally, to summarize, all the above points underline the value of DoCs as a form of insurance for a label printer’s business, as a means of retaining existing customer contracts, and as an entry ticket to end users qualification processes for new business – with the ultimate aim of protecting the consumer.   Producing DoCs to a satisfactory standard creates a level playing field for all operations – however large or small.  

Detailed information on EU10/2011 is available on the FINAT website (www.finat.com).