EU opens comment period on draft BPA regulation


The European Commission has opened a comment period on draft regulation to crackdown on bisphenol A (BPA) limits.

It creates a new specific migration limit (SML) of 0.05 mg/kg food for BPA migrating from varnishes or coatings applied to materials or articles intended for food contact.

Current levels allow an SML of 0.6 mg of BPA per kg of food (mg/kg).

“[To] ensure that the business operators have sufficient time to adjust their manufacturing processes to comply with the restrictions and to reduce the administrative and financial burden that such adjustment may entail, it is appropriate to defer the application of this regulation and to permit materials and articles which have been lawfully placed on the market before the date of application of this regulation to remain on the market until the exhaustion of stocks,” said the Commission. 

Feedback is open until 20 September.

Scale of BPA use

The substance is used in the manufacture of polycarbonate plastic intended to come into contact with food and epoxy resins used in varnishes and coatings.

The Commission said the majority of food and beverage cans (around 80%) use BPA based epoxy-resin technology as a coating.

The EU canning industry has around 90 lines operational. Around 50 billion beverage and 20 billion food cans are produced there each year.

The metal can manufacturing industry has claimed switching to alternative substances would mean a decrease in the shelf life of canned food by one to two years which could lead to increase in food waste.

Use of BPA as a monomer in the production of plastic materials is authorised by Commission Regulation (EU) No 10/2011.

It cannot be used in the manufacture of polycarbonate infant feeding bottles on the basis of the precautionary principle.

Denmark and Belgium have national bans on use of BPA in food contact materials for infants and young children; Sweden has a ban only in coatings and varnishes for food contact materials for infants and young children and France banned BPA in all food packaging, containers and utensils.

“Differences between national laws, regulations and administrative provisions concerning the safety assessment and authorisation of substances used in the manufacture of materials and articles intended to come into contact with food can also hinder the free movement of those materials and articles, creating conditions of unequal and unfair competition,” said the Commission.

EFSA evaluations

The European Food Safety Authority (EFSA) has evaluated the substance numerous times saying in early 2015 that it poses no health risk to consumers of any age group.

A temporary Tolerable Daily Intake (t-TDI) of 4 μg/kg bw per day was set pending the outcome of a long-term toxicity study in rodents by the National Toxicology Program (NTP) and US Food and Drug Administration (FDA). Results are expected this year.

EFSA is re-evaluating the toxicity of BPA with assessment to start in 2018 by the Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) panel.

The review will include other relevant studies published since the December 2012 cut-off point for the last review of safety.

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