The French Government has decided to extend an existing ban on use of Bisphenol A (BPA) in baby bottles to cover the manufacture, importation, exportation and placing on the market of any food packaging containing BPA as from 1 January 2015. BPA is a chemical that is mainly used in combination with other chemicals to manufacture plastics and resins. For example, BPA is used in polycarbonate, a high performance transparent, rigid plastic. Polycarbonate is used to make food containers, such as returnable beverage bottles, infant feeding (baby) bottles, tableware (plates and mugs) and storage containers. Residues of BPA are also present in epoxy resins used to make protective coatings and linings for food and beverage cans and vats. It is understood that BPA can migrate in small amounts into food and beverages stored in materials containing the substance.
FRENCH LAW ON BISPHENOL A AND ITS WIDER IMPLICATIONS
Since 2 July 2010, France has banned the sales of baby bottles containing BPA (Law no. 2010-729 dated 30 June 2010). The French Law no. 2012-1442 adopted on 24 December 2012 extends this prohibition by suspending the manufacture, importation, exportation and placing on the market of any food packaging containing BPA. This prohibition will become effective on 1 January 2015.
Prior to the implementation of an outright ban, the Law seeks to introduce a labelling obligation for food packaging containing BPA, aimed at discouraging the consumption of such packaged food by pregnant women, nursing mothers and young children. The details of this labelling obligation are currently being debated and would be set out in an implementing Decree, which is yet to be adopted, notably due to an obligatory notification procedure at EU level. It seems that the French Government would like this labelling obligation to be applied to all food packaging containing BPA immediately as from the time of adoption of the implementing Decree (possibly in the autumn of 2013) and thus ahead of the formal entry into force of the formal prohibition provided for under the Law of 1 January 2015.
Health issues potentially caused by BPA are taken very seriously by the French Government, which is encouraging manufacturers to start replacing BPA immediately by another substance ahead of the entry into force of the prohibition. This position was clearly confirmed in an official press release published in April 2013, in which the former French Minister for Ecology, Environment, Sustainable Development and Energy, Ms Delphine Batho, stated the following: "From now on, without waiting for the entry into force of the measure, it is essential that manufacturers start replacing this substance, by paying great attention to the innocuousness of the substitutes they will use. Anses' report, indeed, underlines the uncertainties and lack of data on the substitutes of Bisphenol A that the Agency has examined". "Anses" refers to the French Health and Safety Agency.
The French Law prohibiting the use of BPA in food packaging is due to apply not only to food packaging intended for the French market but also to any food packaging manufactured in France and intended to be exported abroad. Indeed, the French law makers are of the opinion that it is neither ethical nor consistent to consider on the one hand, that BPA is dangerous to health and to prohibit its use for French users but, on the other hand, to knowingly allow exports of packaging containing this substance. Thus, during the debates in the French Parliament, Mr Christian Hutin, who is a Member of the National Assembly as well as the Vice-President of the Commission in charge of Social Affairs explained this idea as follows: "With respect to the issue of exportation, I believe it is difficult to prohibit a substance in our territory but authorise its exportation. This is an ethical and moral problem. The French Members of Parliament cannot protect their population while authorising the poisoning of others. The fact remains that exports is a real issue, all the more so when it concerns between 30 and 40% of production, as is the case in the region of Dunkirk."
In EU legislation, the use of BPA is prohibited (in application of the precautionary principle) in infant feeding bottles (Directive 2011/8/EU). However, BPA is permitted for use in food contact materials in the European Union (EU) under Regulation 10/2011/EU, relating to plastic materials and articles intended to come into contact with foodstuffs. BPA is also permitted for food contact use in other countries such as the USA and Japan.
The European Food Safety Authority (EFSA) has carried out a thorough review of BPA on several occasions. Following its first full risk assessment of BPA in 2006, EFSA set a Tolerable Daily Intake (TDI) of 0.05 mg/kg body weight/day for this substance. EFSA updated its advice on BPA in September 2010 following a detailed review of additional scientific literature and studies on the toxicity of BPA at low doses, however, the Panel concluded they could not identify any new evidence which would lead them to revise the TDI for BPA of 0.05 mg/kg body weight set by EFSA in its 2006 opinion.
Nevertheless, EFSA took the initiative in February 2013 to fully re evaluate human risks associated with exposure to BPA through the diet but also through non dietary sources. On 2 July 2013, it announced that it will launch a public consultation on its draft updated and extended assessment of exposure to BPA in Europe. The consultation will be opened from mid July to mid September 2013. This would be followed in early 2014 by a public consultation on the human health aspects of its risk assessment prior to finalising its scientific opinion. For more information, please click here.
In a parallel development, Plastics Europe, the EU trade association of EU plastic manufacturers, lodged a complaint with the EU Commission on 25 March 2013, against the French Law imposing a total ban on BPA. It asks the Commission to initiate infringement proceedings against France under Article 258 TFEU (Treaty on the Functioning of the European Union) for breach of EU (and supposedly WTO) law.
The European Commission seems to be reluctant to take any action before the opinion of EFSA is finalised which may not happen until sometime in 2014. Should EFSA conclude that there are indeed reasons for concern, the European Commission may conclude, similarly to France, that regulatory action is necessary by way of increased use restrictions or even a ban. Should EFSA on the other hand, reconfirm its earlier opinion, the European Commission would need to consider whether to "pursue" France for breach of EU law. This could prove to be an interesting test case for the EU risk regulation model.
Either way, companies directly affected by this measure should follow developments in France and at EU level closely in order to understand to what extent products currently legally on the market may face restrictions going forward. It looks like producers and users of BPA containing food contact materials will be faced with a period of legal uncertainty where French legislation will de facto force them to abide by stricter standards than currently are required under EU legislation.
In view of the public consultations launched by EFSA, companies affected would have an interest in participating and submitting relevant data to EFSA and the European Commission soonest. With France taking such a strong position in their wish to ban BPA, it would appear all the more important for companies producing or using BPA containing food contact materials who are convinced that their products are safe, to have their voice heard now.