Specific migration of plasticisers from food contact materials

Viviana Golja, MSc.

INSTITUTE OF PUBLIC HEALTH MARIBOR

Laboratory in Ljubljana, Grablovieva 44, 1000 LJUBLJANA SLOVENIA

Before the start

http://ec.europa.eu/food/food/chemicalsafety/foodcontact/legisl_list_en.htm

Overview
Plasticisers Legislation Coordinated European project Conclusion

Plasticisers
Additives Most are used in PVC Improve flexibility and durability of plastics: lowering the glass transition temperature making plastics softer

Legislation: PIM
group restriction no 32

PHTHALATES

Legislation
SML PM-no Substance Phthalic acid, benzyl butyl ester (BBP) Phthalic acid, bis(2ethylhexyl)ester (DEHP) Phthalic acid, dibutyl ester (DBP) Phthalic acid, diester with C8C10 (DiNP) Phthalic acid, diester with C9C11 (DiDP) (mg/kg food) 30 QM Parameter to control in single use Food Contact Material * Non-fatty food SML Parameter to control in repeated use Food Contact Material Fatty food Non-fatty Infant food food (non-fatty) SML Limit in fatty food simulant @ (mg/kg simulant D) 30-150 (% in the Fatty food Infant plastic) food 0.1 QM

74560

74640

1.5

0.1

QM

QM

SML

n.r.

74880

0.3

0.05 #

QM

QM

SML

n.r.

75100

9$

0.1

QM

SML

SML

9-45

75105

9&

0.1

QM

SML

SML

9-45

Packaging made from glasses with lid containing a plasticized gasket is usually considered as a single use material; @ Taking the simulant D reduction factor into consideration. When simulant D is 50% ethanol, no reduction factor is of relevance; # only permitted in polyolefins; $ SML(T) incl. DiDP; & SML(T) incl. DiNP n.r., not relevant; QM, maximum permitted quantity of the residual substance in the material; SML, specific migration limit

 Phthalates : note no. 7 on verification of compliance: If testing in food is performed, Annex V 1.4 shall be taken into account Annex V 1.4. Special cases
When contamination occurs from sources other than food contact materials this has to be taken into account when testing for compliance of the food contact materials, in particular for phthalates (FCM substance 157, 159, 283, 728, 729) referred to in Annex I.

Legislation: PIM
group restriction no 32
acetylated mono- and diglycerides of fatty acids polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C 12 -C 22 fatty acids

polyesters of 1,2-propanediol and/or 1,3and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, which may be end-capped with acetic acid or fatty acids C 12 - C 18 or n-octanol and/or ndecanol

tri-n-butyl acetyl citrate

citric acid, triethyl ester

Legislation: PIM
group restriction no 32
adipic acid, bis(2-ethylhexyl) ester sebacic acid, dibutyl ester ESBO glycerol monolaurate diacetate glycerides, castor-oil mono-, hydrogenated, acetates polyester of adipic acid with 1,3- butanediol, 1,2-propanediol and 2- ethyl-1-hexanol terephthalic acid, bis(2- ethylhexyl)ester

neopentyl glycol, diesters and monoesters with benzoic acid and 2-ethylhexanoic acid trimethylolpropane, mixed triesters and diesters with benzoic acid and 2-ethylhexanoic acid

Expression of migration test results

Article 17 PIM
3. for caps, gaskets, stoppers and similar sealing articles the specific migration value shall be expressed in: (a) mg/kg using the actual content of the container for which the closure is intended or in mg/dm 2 applying the total contact surface of sealing article and sealed container if the intended use of the article is known, while taking into account the provisions of paragraph 2; (b) mg/article if the intended use of the article is unknown.

Coordinated European project

In 2011 Official Food Control Authority of the Canton of Zrich, Switzerland Campaign was done with the Chemisches und Veterinruntersuchungsamt Stuttgart, Germany Products of interest:
Food in glass jars with free edible oil

Coordinated European project

Source: presentation G.McCombie, BTSF 2013

Coordinated European project

All EU countries invited Samples were stored in the countries for 6 months (with occasional shaking) to bring them closer to the end of the shelf life A test report was sent to the participating countries In Stuttgart, determination of plasticisers in the gaskets, in Zrich plasticisers quantified in the food (4 analytical methods) 410 samples from all over Europe

Coordinated European project

21 countries participated Source: presentation G.McCombie, BTSF 2013

Results
21 Countries sent in 410 samples 74 non compliant samples out of 307 relevant ones

ESBO; 40 times, up to 12 times over the limit Other individual authorised plasticisers; 23 times, up to 73 times over the limit Use of unauthorised plasticisers
7 times not authorised for given application 2 times not authorised at all for FCM

(some samples did not comply on multiple counts) Source: presentation G.McCombie, BTSF 2013

Coordinated European project

Paper published:
McCombie et al. European Food Research and Technology July 2012, Volume 235, Issue 1, pp 129-137 : Migration of plasticizers from the gaskets of lids into oily food in glass jars: a European enforcement campaign

More than 28 RASFF alerts Phase II

Conclusion

Testing is very difficult task Situation on the market has improved, but is still unacceptable