22-02-13Regulatory situation of bisphenol A as well as materials and articles containing bisphenol A in the European Union and France
Bisphenol A (BPA) is a chemical constituent obtained from the reaction of phenol and acetone. It is used for two third in the polymerization of plastics (polycarbonate) and for one third in the manufacturing of epoxy varnishes. BPA is widely used in industry (automotive, electrical equipments, leisure facilities, buildings) and, in the sector of materials and objects in contact with food, it is mainly used for:
- Polycarbonate culinary utensils;
- Polycarbonate carboys for water fountains;
- Metal packaging coated with epoxy varnishes and used for the packaging of foodstuffs (metallic boxes, metallic caps for glass jars or containers, metallic lid for glass bottles).
As regard to the packaging of foodstuffs, epoxy varnishes for metallic packaging are manufactured by using BADGE (Bisphenol A diglycidyl ether) as a monomer. BAGDE is obtained from BPA, which can be found in the coating as a residual substance.
In accordance with EC regulation n°1935/2004 and specific measures for plastic materials intended to come in contact with foodstuffs, BPA was submitted for a risk assessment regarding its presence in human food to the European health authorities. This assessment resulted in the authorization of BPA as a monomer or original substance with a specific migration limit initially set at 3 mg/kg of food (amended Directive n°90/128/CEE) and then brought back to 0,6 mg/kg of food in 2004 after the European Food Safety Authority “EFSA” conducted a reassessment (Directive n°2002/72/CE modified by Directive n°2004/19/CE). In 2011, the new EU regulation n°10/2011 on plastic materials was amended after the European Commission decided to ban the use of BPA in the manufacturing of polycarbonate baby bottles (UE regulation n°321/2011).
BADGE was also submitted for a risk assessment to the European health authorities. In 2005, it was authorized in the European Union, along with its hydrolyzed derivatives, with a specific migration limit set at 9 mg/kg of food. Its chlorinated derivatives were authorized with a specific migration limit set at 1 mg/kg of food (EC regulation n°1895/2005).
At the beginning of 2013, the harmonized European regulatory situation is as follows:
- BPA is authorized in the manufacturing of plastic materials intended to come in contact with food, except for polycarbonate baby bottles;
- BADGE is authorized in the manufacturing of epoxy varnishes mainly used on metallic packaging intended for foodstuffs.
The situation in France is more complex. After the publication of scientific data that challenge previous studies on BPA toxicity, especially regarding low dose and long term effects, French authorities recently decided to implement safeguard measures allowed, under certain conditions, by article 18 of EC regulation n°1935/2004. By issuing the law n°2012-1442 on December 26th, 2012, France aims at suspending the manufacturing, importation, exportation and placing on the market of all packaging containing bisphenol A intended to come in contact with food. This law modifies the 30/06/2010 law n°2010-729 which had suspended the trade of baby bottles made from bisphenol A and extends its scope to other types of foodstuffs packaging containing BPA. These are mostly metallic packaging coated with epoxy varnishes likely to contain BPA residues. All foodstuffs packaged in metal cans as well as canned drinks are thus covered by this new law.
This suspension occurred on the 1st of January 2013 for objects in direct contact with food intended for infants, within the meaning of Directive n°2006/141/CE. The suspension will take place on the 1st of January 2015 for all other packaging in direct contact with food.
Meanwhile, the government will submit a report on the assessment of potential substitutes for bisphenol A before the 1st of July 2014.
Finally, this law includes additional provisions concerning medical devices and some childcare articles and toys. The use of baby bottles and shields of teats and soothers and teethers containing BPA is strictly forbidden, which will then be followed by a ban on tubings containing DEHP (di-ethylhexyl phthalate) from the 1st of July 2015. In addition, the government will submit a report on endocrine disruptors within a year. The aim of this report is to establish an overview of current knowledge regarding the health consequences of the presence of these substances in food, in the environment, in medical devices and in the human body.
To address these public health challenges, LNE assists industrial players in the health safety assessment of their food contact materials (FCM) by proposing:
- Compliance tests for food contact materials, especially test services regarding the specific and overall migrations of specific constituents, such as bisphenol A.
- Regulatory analyses as well as characteristics and performances analyses of materials to demonstrate their compliance when they come in contact with food and obtain the necessary evidence.
- Assistance or counseling in R&D regarding the design of safer food contact packaging.
- Trainings, technical and regulatory support or else regulatory and scientific monitoring to help industrial players identify the regulations applicable to their food contact materials, understand the regulatory requirements or their interpretations.
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