Industry expresses significant disappointment and concern at the French Senate proposal to restrict Bisphenol A (BPA) in food packaging and in medical devices. The proposal has no safety benefit for consumers and disregards existing European law and risk assessment while disturbing the internal market. The French Senate´s adoption, on 9 October 2012, of a law proposal to impose a use restriction on all BPA-based food contact packaging in France from July 2015 is not supported by the current weight of scientific evidence. It is in conflict with European Union (EU) food contact regulation and the opinions of the European Food Safety Authority (EFSA), and threatens to create a significant distortion of the internal market for food contact goods in the EU. Furthermore, an additional last minute proposal to restrict certain substances (including BPA) crucial in medical devices used by certain parts of the population may actually cause more harm than good for patients. The move is not based on any scientific consideration, has not been risk assessed and fails to take into account the impact of withdrawing critical medical device applications from the marketplace.
The proposed provision to label food packaging containing BPA with a health warning against its use by pregnant women, breastfeeding women and children below three, would add little to consumer choice and would not contribute to increased safety of consumers. Products on the European market are tested and approved for their uses; if compliant with existing legislation, there is no need for a label. The sole effect of such a label would therefore be to discredit and question the suitability of a product that is safe for use and fulfills all legal and regulatory requirements, and would cause
incalculable added costs and complexity for business operators. In compliance with relevant European law, BPA has repeatedly been assessed and confirmed safe for its intended use:
BPA-based materials in food contact comply with strict EU safety rules. There is no evidence that the exposure of consumers or workers to products made from materials based on BPA could cause a safety risk to human health. There is no scientific reason to replace a well-tested, authority-assessed and confirmed as safe product.
EFSA assessed BPA safety in food contact materials in 2006, 2007, 2008, 2010, and 2011 – on each occasion it was concluded that BPA can be safely used in its current food contact applications, including products for newborns and small children. After review of the 2011 French Food Safety Agency (ANSES) report on BPA, EFSA and the European Commission concluded there was no need for any risk reduction measures further to those already in place.
On 27 September 2012, Health Canada released its updated “Assessment of BPA Exposure from Food Sources” and once again confirms that BPA is safe for use in food contact materials. The experts conclude: ‘that current dietary exposure to BPA through food packaging uses is not expected to pose a health risk to the general population, including newborns and young children.”
Strictly concerning medical devices, BPA is used because of its specific properties which allow medical devices to properly function in a complex environment.
The members of the PC/BPA and ERC groups therefore express severe disappointment and concern regarding the potential consequences of the vote of the French Senate on 9 October. By “reversing” the roles between EU and Member States regarding decisions on food safety and rules on medical devices, a dangerous precedent is set whereby established EU risk management processes are ignored, the integrity and credibility of EFSA and other EU risk assessment bodies are undermined and the functioning of the internal market of the EU is severely threatened. The text adopted yesterday in the Senate is different from the one adopted by the National Assembly and will now have to go back to agree on a common text. The new full EFSA reassessment is expected in May 2013 and Member States should hold any national initiatives until this expert opinion is available.
Industry therefore strongly requests that the French government respects the existing EU rules and regulations for food safety and medical devices which are in place and indeed valid and implemented for BPA.
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