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Guideline to the new EU food contact regulation

New plastic materials and additives have been developed in food packaging in order to improve the ranks of materials designed to be used for food contact packaging. The legislation so far referred to is the European Directive 2002/72/EC of 6 August 2002 relating to materials and articles made of plastics intended to come into contact with food. Over the years, this Directive has been amended and revised several times (7 amendments), in order to adapt to technological advances in the field. Following several amendments and massive developments, the European Commission has decided to establish a new regulation to replace, in part initially and then completely, the old Directive including its.Publication of a regulation in the Official Journal of the European automatically makes it active across Europe (member states) without requiring that it be implemented (by decree, for example).
Following the individual changes will be treated in the specific, and their dates of "activation". The new Regulation 10/2011 is a specific measure within the meaning of article 5 of Regulation 1935/2004 that fixes:
Materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could: (a) endanger human health; or (b) bring about an unacceptable change in the composition of the food; or (c) bring about a deterioration in the organoleptic characteristics thereof.
The new Regulation 10/2011 shall apply to:
(a) materials and articles and parts thereof consisting exclusively of plastics; (b) plastic multi-layer materials and articles held together by adhesives or by other means; (c) materials and articles referred to in points a) or b) that are printed and/or covered by a coating; (d) plastic layers or plastic coatings, forming gaskets in caps and closures, that together with those caps and closures compose a set of two or more layers of different types of materials; (e) plastic layers in multi-material multi-layer materials and articles.
It is important defining that all plastic materials, as explained above, can be printed or coated but adhesives, printing ink, coating are not covered by the new Regulation 10/2011. The Regulation also does not cover Ion exchange resins, rubber, silicones.
Simplifying, in order to put a plastic material or a finished article on the European market, the following points must be satisfied:
A) The articles must comply with Articles 3, 15 and 17 of Regulation (EC) 1935/2004
B) The articles must meet:
• the compositional requirements
• the specific rules for multi-layer (homogeneous and heterogeneous)
• must be manufactured in accordance with Regulation (EC) 2023 / 2006
C) The articles must be accompanied by the declaration of conformity (and supporting documentation)
The following substances, in example, can be used, also if not present in the list:
• Colorants and solvents covered by specific national legislations;
• PPA not present in the list can be used according to national legislations;
• Salts (including double salts and acid salts) of aluminium, ammonium, barium, calcium, cobalt, copper, iron, lithium, magnesium, manganese, potassium, sodium, and zinc of authorised acids, phenols or alcohols;
• mixtures obtained by mixing authorised substances without a chemical reaction of the components;
Specific Migration Limits of certain substances:
Barium = 1 mg/kg food or food simulant.
Cobalt = 0,05 mg/kg food or food simulant.
Copper = 5 mg/kg food or food simulant.
Iron = 48 mg/kg food or food simulant.
Lithium = 0,6 mg/kg food or food simulant.
Manganese = 0,6 mg/kg food or food simulant.
Zinc = 25 mg/kg food or food simulant.
The Overall Migration Limit (OML) is fixed to 10 mg/dm2
For plastic materials and articles designed for infants and small children foods (as defined in the European Commission Directives 2006/141/CE and 2006/125/CE, the limit is always 60 mg/Kg of food.There is a change from the old Directive, where the expression of result was in mg/Kg also for container with capacity between 500 ml and 10 Liters; Closures, Lid, Gasket and other closure devices;

At the marketing stages other than at the retail stage, a written declaration shall be available for plastic materials and articles, products from intermediate stages of their manufacturing as well as for the substances intended for the manufacturing of those materials and articles. Business operators are currently basing their declaration of compliance on supporting documentation following the requirements set out in Directive 2002/72/EC. Declaration of compliance need, in principle, only to be updated when substantial changes in the production bring about changes in the migration or when new scientific data are available. In order to limit the burden to business operators, materials which have been lawfully placed on the market based on the requirements set out in Directive 2002/72/EC should be able to be placed on the market with a declaration of compliance based on supporting documentation in accordance with Directive 2002/72/EC until 5 years after the adoption of the Regulation. The minimum requirements for a correct declaration are reported in the Annex IV of the Regulation.

The new Regulation esatblishes the possibility of using screening methods, in support or sostituting the traditional food contact tests. Example of screening appraches are:
• Evaluation of Global Migration Value for the respect of eventual Specific Migration Value;
• Calculation of Residual Content (QM) :calculation of theorical maximum migration, supposing a complete migration of a specific substance;
• Migration modelling: To screen for specific migration the migration potential can be calculated based on the residual content of the sub¬ stance in the material or article applying generally recognised diffusion models based on scientific evidence that are constructed such as to overestimate real migration.
• Food simulant substitutes: To screen for specific migration, food simulants can be replaced by substitute food simulants if it is based on scientific evidence that the substitute food simulants overestimate migration compared to the regulated food simulants.
1 January 2013 is the first deadline; 31 December 2015 is the second deadline. 1 January 2016 will be the final date when Regulation 10/2011 comes into effect completely.
(Source courtsey
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