EFSA gives the nod to 10 more packaging chemicals

The opinions mark the 13th batch of food contact materials EFSA's scientific panel has evaluated for their potential effects on human health. The panel evaluated scientific studies on the chemicals, which were submitted for consideration by food packagers.

EU legislation requires that all materials that come into contact with food comply with healthstandards so that safe food remains safe. The main problem stems from chemicals that can migratefrom the packaging to the foods they contain.

Before a substance is authorised to be used in food contact materials and is included in a positive listof such substances, EFSA's opinion on its safety is required.

In its latest scientific opinion, EFSA evaluated 10 chemicals. Two of them, isophthalic aciddichloride and 9,10-dihydroxy stearic acid and its oligomers, were restricted to a migration levelof 5 mg/kg in food. Vinyltriethoxysilane was restricted to a 0.05 mg/kg migration limit in food andcan only be used as a surface treatment agent on packaging.

Meanwhile EFSA set a total daily intake limit of 0.1 mg/kg body weight on ethylene glycol bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate].

EFSA set no restrictions on hydrogenated homopolymers and/or copolymers made of 1-decene and/or 1-dodecene and/or 1-octene,and on petroleum hydrocarbon resins (hydrogenated).

The EFSA scientific panel set a migration limit of 0.05 mg/kg of food on polyethylene glycol (EO=1-30, typically 5) ether ofbutyl 2-cyano 3-(4-hydroxy-3-methoxyphenyl) acrylate, and on polyethyleneglycol (EO=1-30, typically 5) ether of butyl-2-cyano-3-(4-hydroxyphenyl)acrylate. The two chemicals may only be used with polyethylene terephthalate (PET), a plasticcommonly used to make beverage containers..

The EFSA panel put a restriction of 0.05 mg/kg on poly(ethylene propylene)glycol tridecyl etherand refined paraffinic waxes derived from petroleum based or synthetic hydrocarbon feedstocks.

The panel restricted the use of poly(ethylene propylene)glycol tridecyl ether to the manufactureof polytetrafluoroethylene (PTFE) containers sintered at high temperatures.

The paraffinic waxes studied by the panel cannot be used to contain fatty foods, the panel said.

Late last year the EU yesterday opened a commmunity reference lab for food packaging as part thebloc's plan to ensure the chemicals used in their manufacture do not affect human health.

The new lab, designed to test food contact materials, is based at the European Commission's jointresearch centre in Ispra, Italy. For food processors, the centre will serve as a resource they canrefer to when uncertain about the safety of specific packaging chemicals, such as those used in inksor for making the material.

The new EU reference laboratory will set standards for testing practices for food contactmaterials across the EU. It will also serve as a point of reference for issues relating to theenforcement of legislation on food contact materials. This will be achieved through a network ofnational reference laboratories set up by each member country.

Public and regulatory scrutiny became focused on packaging chemicals last November after Italy'sregulators confiscated millions of litres of Nestlé baby milk due to the discovery that a printingchemical from a Tetra Pak package had migrated into the product.

Nestlé subsequently was forced by court order in Italy to make a recall of about two millionlitres of its Nidina and Latte Mio brands, even thought the EU's food agency found at the chemicalposed no danger to human health at the levels found in the products.

The recall was extended to France, Spain and Portugal. Dutch group Numico was also involved inrecalling some of its products. The crisis subsequently exposed a loophole in food law, as there wasno EU-wide regulation setting limits on benign contact materials.

The issue over ITX also highlighted the uncertainty surrounding current legislation in the EUover the food industry's use of packaging chemicals, a problem that is meant to be fixed under aproposed directive on the registration, evaluation, authorisation and restriction of chemicals(Reach), which is due to come into force later this year.

Currently the EU relies on a negative list to regulate the use of chemicals. This means anychemical not on the European Food Safety Authority (EFSA) blacklist can normally be used forpackaging food.

Current EU regulation also requires that all food packaging materials shall be manufactured incompliance with what the law defines as "good manufacturing practice" (GMP). Proposed EUlegislation made after the Nestlé recall would define the manufacturing practices the bloc'sprocessors would have to take in ensuring that packaging materials do not migrate into foods.

In October a new law came into force, requiring processors to have a traceability system in placefor packaging materials.

The new requirement is a provision of EC Regulation 1935/2004, which deals with materials andarticles that may come into contact with foods. The law was adopted by the bloc last year to updatea previous EU directive on food contact materials.

The regulation entered into force on 3 December 2004, except for Article 17 on traceability,which enters into force on 27 October. The later implementation date was given to provide time forbusinesses to put traceability systems in place.

Traceability requires that processors must be able to provide records to regulators to allow themto follow a material or article through all stages of manufacture, processing and distribution. Therecords should allow the identification of businesses from which and to which packaging and otherfood contact materials originate from.

The regulation covers materials such as rubbers, ceramics, plastics, paper, glass, metals, inks,textiles, waxes, cork and wood.