END OF THE 3-YEAR TRANSITION PERIOD OF PLASTICS REGULATION (EC) NO.

10/2011

Regulation (EC) No 10/2011 on plastic materials and articles intended to come into contact with food came
into effect in May 2011. It replaced the older Directive 2002/72/EC on plastics. The Regulation applies to
plastic food packaging and other plastic food contact materials. For some of the changes introduced in the
Regulation for plastics, the Commission included a three-year transition period so as to reduce the burden on
industry and ensure a gradual move to the new rules. This transition period ends on 31 December 2015.

WHAT IS CHANGING?

With effect from 1 January 2016, there is a change to how plastics intended for use in contact with food must
be tested. There are tests carried out on all plastics to confirm that migration of substances is within the
specified or overall migration limits (SMLs or OML). These migration tests must be done in future under the
test conditions specified in Annex V and using the test simulants in Annex III to Regulation (EC) No 10/2011.

This applies to all plastics food contact materials such as plastic film, trays and bottles. The previous Directive
2002/72/EC on plastics specified that the migration tests were done in line with Council Directive 82/711/EEC,
using test simulants specified in Council Directive 85/572/EEC. (Test simulants are simple materials, usually
liquids, used in migration tests to represent different types of foods.) The old test simulants were:

Food Simulant, Directive 85/572/EEC Abbreviation Used for

Distilled water Food Simulant A Aqueous foods
Acetic acid 3 % (w/v) Food Simulant B Acidic foods
Ethanol 15 % (v/v) Food Simulant C Alcoholic foods
Ethanol 50 % (v/v) Food Simulant D1 Fatty foods
Rectified olive oil Food Simulant D2 Fatty foods

These are being replaced by:

Food Simulant, Regulation (EC) No 10/2011 Abbreviation Used for

Ethanol 10 % (v/v) Food Simulant A Aqueous foods
Acetic acid 3 % (w/v) Food Simulant B Acidic foods
Ethanol 20 % (v/v) Food Simulant C Alcoholic foods
Ethanol 50 % (v/v) Food Simulant D1 Fatty foods
Vegetable Oil Food Simulant D2 Fatty foods
Poly(2,6-diphenyl-p-phenylene oxide), also called Food Simulant E Dry foods
Tenax® or MPPO

The new test conditions are generally more severe than the old ones, and include a simulant to test for
migration into dry foods.

Two other changes are likely to have less impact, as they relate to two specialised types of plastic food contact
materials:

1. Plastic gaskets and coatings applied to metal lids used on glass jars
2. The sizing applied to glass fibres used as a structural component in some plastics (glass-fibre
reinforced plastics)

From 1 January 2016, these two materials will only be allowed to contain additives that are included in the list
of substances in Annex I to Regulation (EC) No 10/2011, in compliance with the restrictions therein.
WHAT DIFFERENCE DOES THIS MAKE?

Migration tests are done to check that food contact materials are only releasing safe amounts of chemicals
into the food. The new tests for plastic food contact materials are generally more severe than the older tests,
so it is possible that plastics which passed testing before may not comply with the migration test limits under
the new conditions. These plastics may no longer be supplied or used for food contact applications.

Plastic food contact materials must be accompanied by a declaration of compliance at all stages of their
distribution. The format for this declaration is specified in Annex IV of the Regulation. The declaration is based
on supporting documentation, including information on raw materials and migration test results. These tests
must be done in line with the new test conditions laid down in Regulation (EC) No 10/2011 so the declaration
of compliance gives more accurate information on migration, compared with the old test conditions laid down
in Council Directive 82/711/EEC. The declaration is particularly important for food manufacturers who
package their food in plastic packaging, as it provides them the information they need to use the packaging
safely. It is vital that the declarations they receive are based on the correct testing and refer to Regulation (EC)
No 10/2011 and not Council Directive 82/711/EEC.

The Food Safety Authority of Ireland (FSAI) is responsible for enforcement of the legislation on food contact
materials. Official controls on compliance with the legislation are carried out under service contracts with the
FSAI, by the National Standards Authority of Ireland (NSAI) in suppliers of food contact materials and by other
agencies in food businesses. From January 2016, inspections will check that plastic food contact materials are
compliant with the new rules.

WHAT SHOULD I DO?

Suppliers of plastic packaging and other plastic food contact materials should, before 1 January 2016, ensure:

 the migration tests they or their suppliers have conducted have been done under the conditions laid
down in Regulation (EC) No 10/2011;
 the declarations of compliance they issue (and that they receive from their suppliers) are based on
tests done under the conditions laid down in Regulation (EC) No 10/2011 and refer to the Regulation
and not Council Directives 82/711/EEC or 85/572/EEC;
 if they supply plastic coatings or gaskets on metal lids or glass-fibre reinforced plastics, that these
materials comply with the compositional requirements of Regulation (EC) No 10/2011.

Food business operators using food contact materials, particularly food manufacturers using plastic food
packaging, should, from 1 January 2016, ensure that the plastic food contact materials they use are
accompanied by declarations of compliance referring to tests done in accordance with Regulation (EC) No
10/2011 and not Council Directives 82/711/EEC or 85/572/EEC.

FURTHER INFORMATION

Information on the legislation on food contact materials: FSAI's page on legislation on food contact materials

Consolidated Regulation (EC) No 10/2011: Consolidated up to March 2014

European Commission’s Union Guidelines on Regulation (EU) No 10/2011 on plastic materials and articles
intended to come into contact with food: EU Guidelines