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Plastic materials intended to come into direct contact with food : What is the impact on laboratories of the recently adopted Regulation (EU) No 10/2011?

Els Van Hoeck, Tina N’Goy, Caroline Evrard and Fabien BolleWIV-ISP, Juliette Wytsmanstraat 14, 1050 Brussel

Packagings and materials intended to come into direct contact with food (Food contact materials, FCM) must comply with several requirements that have been laid down at the European level. Within that context, Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (“PIM” in short, “Plastics implementation measure”) was published on the 14th of January 2011 [1]. This regulation replaces the following documents:• the plastic materials directive (Directive 2002/72/EC) [2] • the directive laying down the basic rules for testing migration (Directive 82/711/EEC) [3] • the directive laying down the list of simulants to be used (Directive 85/572/EEC) [4] • the directive on the use of vinyl chloride monomer [5]However, this new regulation also includes some important amendments that may have a significant impact on laboratories performing migration tests in order to check the compliance of packagings. These amendments will be discussed further in this text.

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Scope of Regulation No 10/2011

Over the past few years, an increasing number of materials intended to come into contact with food have been used. These materials not only consist of plastic materials, but of multi-layer materials that are held together by adhesives. They may also be printed or covered by a coating or used as gaskets in caps and closures that together with those caps and closures compose a set of two or more layers of diff erent types of materials. Such materials are referred to as ‘multi-layer materials and objects’, composed of diff erent materials. Each of the layers of such materials must comply with the Regulation, except when there is a functional barrier between the plastic material and the food. This regulation does not apply to ion exchange resins, rubber and silicones. A number of materials to which the regulation applies are shown below.

Directive 2002/72/EC contains diff erent lists of monomers and other starting substances as well as additives categorized according to their authorization status. These lists have been assembled into one list, the so-called ‘EU list’. Only the substances mentioned on the ‘EU list’ may be used intentionally in the manufacturing of plastic materials and objects. Are included in this list :• monomers and other starting substances, • other additives than dyes, • other aids to polymerisation than solvents, • macromolecules obtained by microbial fermentation. Adhesives, inks and varnishes do not necessarily contain the same substances as plastic materials and are there-fore still regulated by other rules of the European Union or EU Member States. Another category of substances that are not covered by the Directive are dyes, solvents and non-intentional added substances (NIAS). The use of nanoparticles is forbidden except when the risk has been assessed by the EFSA and their use has been authorized.

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How to perform migration tests?

The migration of contaminants from packagings and other materials to foodstuff s is assessed by means of migra-tion tests. Migration can be assessed in two ways, i.e. by determining the specifi c migration or the overall migra-tion. Since it is hard to bring together the material and all foodstuff s it may come into contact with, migration testing is done by means of simulants. The way in which migration tests may be performed is shown below. Packagings may be tested using a migration cell. Plates, beakers, … are fi lled with the simulant and kitchen tools are sub-merged into the simulant.

A summary of the choice of simulants and of the amendments made by the new Regulation is given in the table below:

Type of food Simulant 2002/72/EEC EU No 10/2011

Watery (pH > 4,5) A Distilled H2O 10 % Ethanol (v/v)

Sour (pH < 4,5) B 3 % Acetic acid (m/v) 3 % Acetic acid (m/v)

Alcoholic C 15 % Ethanol (v/v) 20 % Ethanol (v/v)

Half fatty D (b) 50 % Ethanol (v/v) D1: 50 % Ethanol (v/v)

Fatty Olive oil D2: Plant oil

Dry E / MPPO (Tenax)

In addition the temperature and the duration of migration for real use circumstances, or according to the worst case scenario, are determined. These conditions have been laid down in previous directives but are now as-sembled and harmonized in the new Regulation 10/2011. A distinction is made between overall migration and specifi c migration. The new standard testing conditions for overall migration are mentioned in the table below:

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Test Expected contact with food Migration test conditions

OM1 Contact with frozen and cooled food 10 days @ 20°C

OM2Long storage at room temperature + short heat-ing

10 days @ 40°C

OM3 Short heating 2 hours @ 70°C

OM4 High temperature use 1 hour @ 100°C

OM5 High temperature use (up to 121°C)2 hours @ 100°C Or 1 hour refluxing @ 121°C

OM6Use of simulant A,B or C at a temperature of more than 40°C

4 hours @ 100°C or 4 hours refluxing

OM7 Use of fatty food at a high temperature 2 hours @ 175°C

As for specific migration, both the times and temperatures of contact have been laid down in Regulation No 10/2011. Both can be found in the table below (printed in red : changes when compared to the previous Directives).

Contact time in worst foreseeable use Contact time for migration test

t ≤ 5 min 5 min

5 min ≤ t ≤ 0,5 hour 0,5 hour

0,5 hour ≤ t ≤ 1 hour 1 hour

1 hour ≤ t ≤ 2 hours 2 hours

2 hours ≤ t ≤ 6 hours 6 hours

6 hours ≤ t ≤ 24 hours 24 hours

1 day ≤ t ≤ 3 days 3 days

3 days ≤ t ≤ 30 days 10 days

30 days ≤ t Specific conditions

Interpretation of results According to Regulation (EU) 10/2011 all results must be reported in mg/kg. There are, of course, certain exep-tions to that rule:• Materials that may be filled with a volume of 500 ml to 10 l and/or materials used for babies and young infants• > In that case the real surface/volume ratio should be taken into account. • Materials with a volume of less than 500 ml or more than 10 l and/or when calculating the surface of the material and the volume of food is not practical• > In that case the conventional surface/volume ratio of 6 dm² per kg food should be taken into account.

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Conclusion

This new Regulation, 10/2011, includes certain changes in the conditions/simulants to be used in migration test-ing for the assessment of plastic materials used for manufacturing packagings and other materials that come into direct contact with foodstuffs. A transition period had been provided for, but as of January 1st 2013, all laboratories have to use these new migration simulants and apply these new testing conditions.

References

[1] Commission Regulation No. 10/2011 on plastic materials and articles intended to come into contact with food.

[2] Council Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs.

[3] Council Directive 82/711/EEC laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs.

[4] Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constitu-ents of plastic materials and articles intended to come into contact with foodstuffs.

[5] Council Directive 78/142/EEC on the approximation of the laws of the member states relating to materials and articles which contain vinyl chloride monomer and are intended to come into contact with foodstuffs.

els.vanhoeck@wiv-isp.be