As published in EU Food Law To date, Bisphenol A (BPA) remains a source of concern for authorities on both national and European level. To ensure the protection of human health on their territory, individual Member States - that do not consider BPA to be safe - have introduced restrictions on BPA, of which the French restrictions are the most far reaching. The legitimacy of these measures is being questioned. Beyond dispute, however, is that the lack of uniform national rules on BPA creates a lack of legal certainty for the industry and poses a threat to the objectives of the single market, writes Katia Merten-Lentz of international law firm, Keller & Heckman.

Bisphenol A (BPA) is a chemical that is mainly used to manufacture plastics and resins, which in turn are extensively used in food contact applications.

At EU level, the use of BPA is regulated by the general rules on food contact materials, which are laid down in Regulation (EC) 1935/2004.

This Regulation provides the legal basis for setting specific measures for certain types of food contact materials, including the use of BPA. In addition, the use of Bisphenol A as a monomer in the production of plastic materials and articles, intended to come into contact with food, is authorised by Commission Regulation (EU) No. 10/2011 subject to a Specific Migration Limit (SML).

French restrictions

Article 18 (1) of Regulation (EC) No 1935/2004 foresees that as a result of new information or a reassessment of existing information, an EU Member State can conclude, on detailed grounds, that the use of a material or article endangers human health. Consequently, such Member State can undertake safeguard measures, i.e. temporarily suspend or restrict the application of specific provisions.

Using this provision as a legal basis, some EU Member States have introduced national bans on the use of BPA in both plastic food contact materials and other materials, such as coatings.

Most notable in this regard is France, which in its restrictions on BPA has gone even further than other EU Member States. Having based its reasoning on the Opinion of the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), France adopted, on 24 December 2012, Act 2012-1442 aimed at suspending the manufacture, import, export and placing on the market of any packaging, container or utensil containing Bisphenol A and which are intended to come into direct contact with food.

EFSA assessment

These measures seem to contradict the opinion of European Food Safety Authority (EFSA), which was published shortly after 1 January 2015, when the French law banning Bisphenol A in food contact materials entered into force.

EFSA’s comprehensive re-evaluation of the substance in terms of exposure and toxicity concluded that ‘Bisphenol A poses no health risk to consumers because current exposure to the chemical is too low to cause harm’.

Amendment to the French law

The industry strongly opposed the French BPA restrictions. At the request of a trade association representing the plastics industry, the French Constitutional Court was questioned to review the law which banned BPA.

As a result, the Constitutional Court has partially overturned the French restrictive measure for the manufacture and the export of the substance (Decision No 2015-480).

The French Constitutional Court considered that as the marketing of packaging, containers or utensils, which contain BPA and intended to come into direct contact with food, is allowed in many countries, the suspension of the manufacture and the export from France do not affect the marketing of these products in those countries.

Therefore, while it is currently prohibited to export Bisphenol A in food packaging to France, it remains legal for French companies to manufacture and export it to the rest of the EU.

EU regulation of BPA

Following the risk assessment provided by EFSA in its 2015 re-evaluation of BPA, the European Commission proposed to lower Specific Migration Limit (SML), applicable to plastics, coatings, and varnishes for metals and other food contact sources of BPA, from 0.06 mg/kg to 0.05 mg/kg. This value is well below an SML (0.24 mg/kg food) based on the temporary Tolerable Daily Intake (TDI) of 4 µg/kg body weight/day which had been set by the European Food Safety Authority (EFSA) in 2015.

The European Commission aims to introduce these changes in 2017, although the progress of the draft measure on Bisphenol A has been slowed down by the adoption of the endocrine disruptors’ criteria. Once a lower limit for Bisphenol A is in place, the Commission indicated that as a next step it would address current national restrictions against BPA in food contact materials, including the ban in France.

In the wake of a review of national restrictions, it is also important to mention the position of the European Parliament, which in October 2016 called for a ban on the use of BPA in all food contact materials. The latter does not create an obligation for the Commission to act, but adds to the overall uncertainty regarding the future of this substance.

Legitimacy of restrictions

France continues to be blamed for a ‘very broad application of the precautionary principle’. The industry claims that with the scientific opinion of EFSA confirming there is no risk regarding BPA exposure for consumers, the French BPA ban is a disproportionate measure.

Indeed, having recently reviewed two studies concerning the possible effects of BPA on the immune system of animals, EFSA reiterated last October its original position that the substance poses no risk to consumers.

However, on 16 June 2017, following the proposal of French ANSES, Member State Committee (MSC) of the European Chemicals Agency (ECHA) unanimously agreed to identify BP as a “substance of very high concern” besides its previous classification as toxic to reproduction substance and endocrine disruptor. Concretely, in the future, this could lead to the obligation for the industries to notify the ECHA about every product containing BPA they produce or import.

To have the chemical reviewed by EFSA again in light of new scientific data, including the recent opinion of the ECHA, the Commission mandated EFSA to conduct a new re-evaluation of BPA with a final scientific opinion scheduled for 2018. Incidentally, and for the first time, EFSA has done a public consultation on it scientific protocol for this next re-evaluation, opened until the 3rd September 2017.

Consequences

French restrictions on BPA have far-reaching consequences for the industry. While contributing to the loss of consumers’ trust, divergent national rules on BPA also lead to a lack of legal certainty for EU food business operators.

Already in March 2013, PlasticsEurope alleged that the French Act 2012-1442 is not in conformity with the EU legislation on food contact materials and filed a formal complaint to the European Commission.

The Commission is now under the obligation to analysethe French measure and decide whether it was necessary and justified and consequently take action by either adopting or declining it.

In case the Commission initiates formal infringement proceedings for breach of the EU law, it could result in a heavy financial penalty for France. In addition, business operators whose rights were violated by the ban on BPA could bring multiple actions against the state.