Date: October 2016
Plasticisers are added to plastics in particular, in order to give them the desired flexible properties. But they are also used in varnishes, paints and coating agents, in products made from rubber or elastic as well as in sealing compounds and textiles. The use of plasticisers can be divided into inner and outer plasticising. In inner plasticising, the plasticisiers are chemically bound, meaning that there is no or hardly any diffusion from the plastic. Where outer plasticisers are used, the plasticisers are not bound with the polymer chemically, but physically, and can therefore migrate out of the material. Particularly for foodstuffs, there are countless sources of contamination through migration during production (pipes and containers), closures (twist-off lids) as well as plastic packaging. What’s more, plasticisers enter packaging material via the paper recycling process, due to their use in printing inks and dispersion adhesives.
Many plasticisers are classified as being harmful to health, and have various effects on the organism. Some are classified as endocrine disruptors, which induce changes to the hormone system. Other plasticisers are suspected of being toxic to the liver and triggers for diabetes, cancer, infertility and obesity. Although there are indeed limit values for numerous plasticisers used in food packaging, people not only take in plasticisers via food, but also in the air they breathe in and from the environment around them. Due to their toxicological classification, the use of some plasticisers is forbidden in some products, such as toys, baby products, cosmetics or food packaging.
To date, toxicological classification has only been on the basis of individual plasticisers. However, to determine the effects of multiple plasticisers, in future the EU wants to determine threshold values for groups of them.
The legal basis for analysing phthalates in consumer goods is as is defined in Directive (EC) 1935/2004. As a special measure in this directive, plastics are covered separately in Directive (EU) 10/2011. In Appendix I, table 1, as well as the specific migration thresholds and group limitations for plasticisers, other limitations are specified, such as the use of certain plasticisers (eg DEHP) only in fat-free foodstuffs. The group limitation (no 32 in table 2 of Directive (EU) 10/2011) applies to all plasticisers named in this directive, and is a sum with a specific migration value of 60 mg/kg. For the phthalates DINP and DIDP, a group limitation (no 26 in table 2 of Directive (EU) 10/2011) of 9 mg/kg also applies.
In March 2016, the German Federal Association of Natural Food and Natural Products (BNN) updated its guidelines relating to plasticisers in organic oils and fats. To minimise the intake of plasticisers, good manufacturing practice now requires that objects made from soft PVC are not used at all in the entire process chain. The guidelines for DEHP and DPB were reduced to 1 mg/kg in each case. From analysis results of 1 mg/kg, research into the causes is recommended. If these guidelines are exceeded, oils or fats are no longer suitable for organic food product retail. For all other adipates and phthalates, a guideline of 5 mg/kg applies. These guidelines are stipulations set by the trade itself. All legal requirements continue to apply.
For determining plasticisers in foodstuffs and food packaging, our range of services covers a wide range of substances, such as phthalates, adipates, citrates and phosphates. The plasticisers are extracted from the homogenised sample with a cyclohexane/ethylacetate mixture. Depending on the matrix, the sample may undergo additional purification using gel permeation chromatography. Quantification is by methods of our internal standards, using GC-MS. Using the analysis methods established at the Institut Kirchhoff Berlin GmbH, we can analyse the following plasticisers: