If a company places products on the market that come into contact with food, the materials and articles must comply with the requirements of Regulation (EC) 1935/2004 and the German Food, Commodities and Feed Code (LFGB). If a specific measure is laid down for the materials concerned, the requirements of this measure must also be complied with. One such specific measure for plastics is REGULATION (EU) No 10/2011, the latest update of which (M15) was brought into force by Regulation (EU) 2020/1245 on 24 March 2021. Such updates are usually carried out twice a year.
But what has changed now?
In the last update (M15), the stability test was introduced as an additional factor for articles with multiple uses. Up to now, migration was checked by means of three tests (e.g. 3 x 4 h 100 °C in acetic acid), whereby only compliance with the limit values was assessed. With the introduction of the stability test as an additional factor, all three tests are now also evaluated against each other, whereby the values for both specific migration (SML) and global migration (OML) must not increase in the course of the three tests.
REGULATION (EU) No 10/2011 is a specific measure for plastics and does not cover tests of non-stick coatings on metal surfaces. Therefore, for metal migration, Council of Europe Resolution CM/Res (2013)9 should be applied.
Why is REGULATION (EU) No. 10/2011 relevant to us at all?
However, due to the lack of harmonised European regulations for coatings, it has become common practice to apply the limit values of REGULATION (EU) No. 10/2011 to coating materials as well. However, this only refers to the limit values of the individual substances used as a reference. I.e. some test institutes have applied the test conditions of the regulation to other consumer goods such as baking tins pots and pans.
What do our customers have to do now?
Due to the different legal interpretations, sales territories, construction methods, materials, requirements and expectations of the various commodities, we recommend that the testing conditions be coordinated throughout the supply chain, taking into account the specific conditions, in order to produce both safe and economical products and to avoid delays due to duplicate testing.
Our basic recommendation in this regard is: Simulant
| Test | Abbreviation | Simulant | Test Condition |
Globalmigration | OML | Acetic acid 3 % | 3 x 4 h 100 °C, Valuation of the 3rd value |
Globalmigration | OML | Ethanol 95 % | 3 x 6 h 60 °C, Valuation of the 3rd value |
Globalmigration | OML | Isooctan | 3 x 4 h 60 °C, Valuation of the 3rd value |
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| Metal migration | SRL | Citric acid, 0,5 % | 3 x 2 h 100 °C Implementation and evaluation according to Council of Europe Resolution CM/Res(2013)9 |
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specific migration organic | SML | Acetic acid 3 % | 3 x 2 h 100 °C |
| specific migration organic | SML | dest. Wasser | 3 x 2 h 100 °C |
| specific migration organic | SML | vegetable oil with < 1% water saponfiable matter | 3 x 2 h 175 °C |
alternative Isooctan | 3 x 3 h 60 °C | ||
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| For specific migration, selection of simulants depending on the expected migration rates according to food contact declaration, values according to VO 10/2011 | |
Head of R&D
Phone: +49 6471 315 185
Fax: +49 6471 315 5185
E-Mail: f.pfeifer@weilburger.com
WEILBURGER Coatings GmbH
Ahäuser Weg 12-22
35781 Weilburg
Germany
