RASFF summary of 2005; Notifications concerning food contact materials

The following  issues were reported in RAFFS in relation to food contact materials:

2,6-dimethoxy-p-benzoquinone	1
2-ethyl-hexanoic acid	1
4,4-diaminodiphenylmethane	11
aniline	1
DEHP - di(2-ethylhexyl) phthalate	1
di(2-ethylhexyl)adipate (DEHA)	2
DIDP - diisodecyl phthalate - diisopropylnaphtalene isomers	1
epoxidised soybean oil (ESBO)	2
formaldehyde	3
hydroxy-3,5-dimethoxybenzaldehyde	1
isopropyl thioxanthone	61
primary aromatic amines	21
substances used for wood treatment	1
total migration	11
volatile organic constituents	1

1. Primary aromatic amines

Directive 2002/72/EC Annex V specifies that plastic materials and articles should not release any primary aromatic amines (PAA) into food or food simulant in detectable quantities. The detection limit is set at 0.02 mg of PAA expressed as aniline and already includes an analytical tolerance. Exempted are PAAs which are listed in the Directive.
PAAs are suspected human carcinogens. They can be formed primarily from isocyanates used in glues or adhesives in laminates and from azodyes used as colorants. Other sources for formation of PAAs may exist.
Rapid alerts on PAAs relate in most cases to the migration from kitchen utensils made of nylon imported from China. National enforcement campaigns on PAAs detected several non-compliances with the EU limit. A possible source for PAAs could be the black dye used in the manufacturing of the nylon. The Commission services have contacted the Chinese authorities concerning the increasing numbers of notifications on food contact materials imported from China also sending references of the legislation applicable.
The Commission’s Directorate General Health and Consumer Protection and the Chinese Agency for Quality Supervision Inspection and Quarantine (AQSIQ) signed a Memorandum of Understanding on product safety. It aims to establish better communication and co-operation between the responsible authorities on general product safety, food safety, and sanitary and phytosanitary (SPS) issues, with a view to boosting the overall protection of both EU and Chinese citizens. The Commission envisages a mission of the Food and Veterinary Office to China in 2006 with the aim of further increasing communication and co-operation in the area of control of food contact materials.

2. Migration of lead from ceramic ware

Directive 84/500/EEC lays down migration limits for lead and cadmium from ceramic ware into 3% acetic acid. The levels are the following:

Directive 2005/31/EC foresees a declaration of compliance for ceramic articles and appropriate documentation to demonstrate that the ceramic articles comply with the migration limits for lead and cadmium to be made available by the manufacturer or the importer into the Community to the national competent authorities on request. That documentation shall contain the results of the analysis carried out, the test conditions and the name and the address of the laboratory that performed the testing.
Adverse health effects to humans, caused by very high lead intakes from food, which has been stored for longer periods in ceramic articles with a high transfer rate of lead, cannot be completely ruled out today. The symptoms of mild lead poisoning tend to be rather non-specific like tiredness, headache and the onset of anaemia. Neurological disorders may also occur especially in developing organisms like foetuses, infants and small children. Chronic lead poisoning can manifest itself in a feeling of faintness, loss of appetite, nervousness, nausea and weight loss. The Provisional Tolerable Weekly Intake (PTWI) of lead is 25 µg/kg body weight. The Provisional Tolerable Weekly Intake (PTWI) of cadmium is 0.7 µg/kg body weight.

3. Heavy metals migrating from metal ware such as chromium, nickel

Metal ware is not specifically regulated at Community level. It is covered by the Framework Regulation (EC) N° 1935/2004 on materials and articles in contact with food according to which materials and articles should not transfer substances into food in concentrations that may endanger human health and/or change the composition, the taste or odour of the food in an unacceptable way.
Specific national legislation on metal ware exists in some Member States. The RASFF notifications originate all from the Member States that have national legislation in place. In these countries regular controls are carried out to verify if the levels present are in accordance with this legislation.

4. Migration of isopropylthioxanthone (ITX) from carton packaging

In September 2005, the Italian competent authorities informed the European Commission via a RASFF notification that some batches of liquid baby milk contained a substance called isopropylthioxanthone, in short ITX. It was present in the milk at levels of up to 250 parts per billion (ppb). ITX is a photoinitiator used in printing inks for offset printing on the outside of beverage cartons. Following the notification, the concerned business operators informed the Commission that this substance was accidentally present due to the manufacturing process in which the multilayer cardboard was rolled on reels and the substance was then transferred from the outer printed surface to the inner plastic surface prior to the construction of the individual cartons.
The Commission informed all Member States through the RASFF on all notifications and on information exchange between the Commission and the concerned business operators. In addition, on 6 October 2005, further information was provided at a meeting of Member States experts.
Industry provided its own risk assessment on ITX and indicated that there was no health risk. Nevertheless, the Commission asked industry to provide the toxicological dossier and sent this data to EFSA for advice. Following the withdrawal of concerned products from the Italian market on 22 November 2005 and a preliminary EFSA statement on ITX on 24 November 2005 indicating no immediate health concern, the Standing Committee on 30 November 2005 concluded that there was no need to take measures at EU level. This conclusion was supported by EFSA’s opinion of 9 December 2005 stating that the presence in food, whilst undesirable, does not raise health concerns at levels reported.
The major beverage carton producer committed to cease the use of ITX in packaging for all baby milk as from the end of September 2005, for fatty products by the end of December 2005 and for other concerned products by end of January 2006.
To date, no Member State other than Italy has taken measures. The Italian Ministry has intensified controls on products on the market, including milk products and fruit juices and continues to withdraw the batches where ITX was found.
Neither cartons nor printing inks are yet subject to detailed EU harmonisation. They are covered by the Framework Regulation (EC) N° 1935/2004 on materials and articles in contact with food according to which materials and articles shall not release substances into the food which endanger human health and/ or bring about unacceptable changes in the composition of the food or bring about a deterioration of the organoleptic properties of the food. As in all cases, the overall requirement that food must be safe applies under the primary responsibility of the food industry.
To avoid similar contamination incidents, the Commission will propose a measure detailing the requirements for good manufacturing practice which the packaging industry should apply. This measure will be proposed to the Member States as an implementing measure of the Regulation on food contact materials.

This page is a edited summary of the food contact materials part of the 2005 RAFFS report. The full document can be found here.