NOTIFICATION 2013/230/F BY FRANCE CONCERNING THE PROPOSED DECREE ON LABELLING OF FOOD
CONTACT MATERIALS CONTAINING BISPHENOL A (BPA)
On 2 May 2013, France notified the European Commission of its intention to adopt a decree laying out
the conditions for a health warning to be added to all BPA-based food packaging and objects coming
into contact with food and marketed to the final consumer. The label would caution against
consumption by breastfeeding and pregnant women, and children up to the age of 3 years. The
standstill period, as per the notification procedure laid out in Directive 98/34/EC, ends on 5 August
FoodDrinkEurope, the food packaging value chain (EMPAC) and the raw material producers (PC/BPA
Group and Epoxy Resin Committee of PlasticsEurope) make the following comments about the proposal
to label BPA-based food packaging: The labelling
will create a distortion of the free movement of goods in the European Single market as well
as in the global food market
will cause disproportionate costs for businesses, in particular SMEs, not only in France, but in
all EU Member States and countries globally importing food to the EU
will create unjustified concern and add little to no choice for consumers rather than enhance
is not justified nor proportionate based on existing safety assessment of BPA-based food
contact, including the most recent one from the European Food Safety Authority (EFSA, 2011)
undermines the existing EU food contact regulation and its institutions.
The European joint value chain industries affected by this proposed French measure therefore strongly
call on the European Commission and the Member States to submit reasoned objections to the
proposed French measure by filing a “detailed opinion”, as per European Union Directive 98/34/EC
laying down a procedure for the provision of information in the field of technical standards and
Detailed comments about the proposal to label BPA-based food packaging
A. The proposed labelling will create a distortion of the free movement of goods in the European
Single market as well as for the global food market
The notified decree defines the implementation conditions of a national law which can only apply to its
territory. Therefore, “market” can only be understood as applying to the French market. The obligation
to apply a label on BPA-based food contact materials marketed in France imposes a specific additional
requirement on products that are legal in all other Member States. Producers and manufacturers based
outside France will not be allowed to sell their products on the French market due to such a
requirement from the date the proposed national law would become enforced. This would seriously
affect the functioning of the EU Single market. Similarly, producers and manufacturers outside the EU
would encounter barriers to the import of their products to France which would translate in a disruption
of the international market.
The labelling decree exempts from labeling products which have been put on the French market before
the enforcement date. This means that a can which was produced in, or was imported to France before
the enforcement date is exempted from labeling, while if the can was produced outside France, put on
the European market but not on the French market and is only imported after the enforcement date, it
is not exempted.
Products intended to be put on the market around 1.10.2013 are already produced and ready for
shipment to their destinations since several months. Imported fruit and vegetables, for example, are
largely delivered to the EU via the ports in Rotterdam and Antwerp. These products have already
entered the EU, but not yet their destination countries.
In practice, for a can imported to France, this means: The food or beverage can which is legal for sale in
France if crossing the French border on the 30th of September will become illegal if entering France on
the 1st of October, while still continuing to be legal in all other EU countries. Products are thus not
equally treated in the EU, which is a clear distortion of the Single EU Market.
B. Labelling would cause disproportionate costs for businesses, in particular SMEs, not only in
France, but in all EU Member States and countries globally importing food to the EU
The labelling of BPA-based food contact materials is intended to be a short term measure in France, to
be applied until the entry into force of a total restriction on BPA in food contact materials starting on 1
January 2015. Requiring a label will incur significant additional costs for producers and manufacturers
and in particular SMEs. Business and economic impact of labelling is disproportionate given the short
time spam of application, i.e. potentially 14 months.
In many cases, food packaging manufacturers have already produced packaging which will be sold on
the EU market after October 2013, the enforcement date currently foreseen by France. In addition, since
the draft decree on labelling is not finalised and may be adopted potentially only in early August 2013,
manufacturers would only have two months to adapt their packaging and add the label. It is impossible
for manufacturers and importers of food products to change the packaging/add a French market
labelling to their products within such a short timeframe. Realistically, such a transition requires a
minimum of 6 months, but generally it is at least 12 months.
For a business outside France that has a proportion of output from a given production site which is
exported to France, the practical choices are to either stop exporting and loose that volume, or move
the whole production to comply with French law at an additional cost across that entire volume.
Separate stocks of packaging articles in the same production location would add complexity and costs
due to specific line switching to produce for France.
In practice, this means for example: canned tomatoes from Italy, or canned Spanish fish, if they are
already produced, may not be delivered to France after 1.10.2013, and for several further months.
Because of their seasonality, this may result in a shortage of supply for French consumers. SME´s will
lose considerable business.
C. The proposed measure would create unjustified concern and add little to no choice for consumers
rather than enhance their protection
BPA-based materials in food contact comply with strict EU safety rules. There is no validated evidence
that the exposure of consumers food packaging made from materials based on BPA could cause a safety
risk to human health. The proposed labelling of BPA-based food packaging would only cause unjustified
concern for consumers.
Furthermore, to date, for a number of BPA-based food contact materials such as cans, there are no
equally proven alternatives. The French measure requires ANSES to report to Parliament on the safety of
alternatives and to-date industry does not know the criteria which will be used to make that
Moreover, for some segments of packed food, there are currently no options for packages without
intentionally added BPA. Therefore, labelling of these products would not encourage an informed
consumer choice and would only entail avoidance of the products by consumers.
For a range of products the mandatory labelling will be inappropriate since they are not intended to be
consumed by children, pregnant or breastfeeding women, anyway (i.e alcoholic beverages)i
In addition, for certain packaging, suppliers have noted that technically unavoidable trace amounts of
BPA can be detected even though BPA is not intentionally used in the packaging. Therefore there may
be packaging which could contain trace amounts of BPA but which are not be labelled as they are not
BPA-based. The French labelling requirement is not – and far from it – a guarantee that there is no BPA
present in the product, and therefore the claim is misleading, regardless of wording, because the
presence of BPA in the final product is not only from packaging. The consequent assumption by
consumers that the absence of a label implies that the packaging is BPA-free would actually be
D. The proposed labelling is not justified nor proportionate based on existing safety assessments of
BPA-based food contact materials, including the most recent one from the European Food Safety
Authority (EFSA, 2011).
There is no evidence that the exposure to food contact products made from BPA-based materials causes
a risk to human health, including for newborns, children, breastfeeding or pregnant women.
EU and authorities around the Globe repeatedly risk assessed the use of BPA in such applications and
confirmed its safety. Since 2006 the European Food Safety Authority (EFSA) alone has undertaken four
thorough assessments of BPA; these assessments corroborated that BPA is safe for use in products
coming in contact with food. 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.
In April 2013, the US Food and Drug Administration (FDA) published an interim update of an ongoing
evaluation of the most recent science on BPA1
. The FDA reconfirmed the safety of the substance: “FDA’s
current assessment is that BPA is safe at the very low levels that occur in some foods. This assessment is
based on review by FDA scientists of hundreds of studies including the latest findings from new studies
initiated by the agency.”
Already in April, the Government of Canada released the results of the second Canadian Health
Measures Survey (CHMS) covering the period 2009-20112
. These results showed that typical BPA intake
is more than 1,000 times below safe intake level and they reconfirmed Health Canada´s statement from
2012 “that current dietary exposure to BPA through food packaging uses is not expected to pose a
health risk to the general population”.
Most importantly, EFSA is performing a new assessment on BPA to be released in early 2014
Authority is reviewing a new report4
on BPA released by ANSES on 9 April 2013 and new data from lowdose studies ongoing in the United States of America. EFSA will particularly focus on exposure of
vulnerable groups, including children, assessing dietary exposure but also the contribution of nondietary sources.
The labelling proposed by France is unjustified as the studies upon which the proposed measure is based
have either been dismissed or will be further assessed in reasonable delays, i.e. in early 2014.
In addition, as EU and other authorities (US FDA, Health Canada, FSANZ) repeatedly risk assessed the use
of BPA in food contact applications and confirmed its safety for consumer in its current uses, a labelling
obligation would be disproportionate.
The mandatory mention will be misleading for alcoholic beverages which are not intended for any of the target
consumers (children, breastfeeding and pregnant women). Such mention will also be disproportionate and
superfluous with current law already prohibiting distribution of alcoholic beverages to minors and a health warning
for pregnant women affixed on them.
US Food and Drug Administration http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm064437.htm
Government of Canada http://www.statcan.gc.ca/pub/82-625-x/82-625-x2013001-eng.htm
European Food Safety Agency (EFSA) update,