Dr Nikhil Gokani, Lecturer in Consumer Protection and Public Health Law at the University of Essex, Chair of the Alcohol Labelling and Health Warning International Expert Group at the European Alcohol Policy Alliance, Vice President of the Law Section at the European Public Health Association, and member of the Technical Advisory Group on Alcohol Labelling at WHO.
Alcohol and the
need for effective alcohol labelling
Alcohol is a causal factor in more than 200 diseases, injuries and disabilities. Even at lower levels of consumption, alcohol is associated with increased risks of heart diseases and stroke, liver cirrhosis, cancers and foetal alcohol disorders. In the EU, alcohol consumption causes between 255,000 and 290,000 deaths per year. Beyond health, alcohol results in significant social and economic losses to individuals and society at large.
Despite negative consequences of drinking alcohol, consumer awareness of its harms is low. The World Health Organization (‘WHO’) has repeatedly called on States to provide consumers with essential information through alcohol labelling. The EU has itself acknowledged the importance of consumer alcohol information, reflecting the foundation of EU consumer protection policy that consumers can be empowered through becoming well informed.
EU level regulation of alcohol labelling
Current EU rules in Regulation 1169/2011 on the provision of food information to consumers (‘FIC Regulation’) require alcoholic beverages with a content over 1.2% alcohol by volume (‘ABV’) to include alcohol strength on the label. Other health-related information, including ingredients list and a nutrition declaration, which are required on the labels of most food products, are exempt for alcoholic beverages above 1.2% ABV. EU law does not require any other health-related information to appear on the label.
Member State developments on alcohol labelling
Health-related warnings are not explicitly addressed under EU law and several Member States have introduced national mandatory labelling rules. These have focused on two forms on messaging: mandatory labelling relating to the age of consumption, and messaging against drinking during pregnancy.
In October 2018, Ireland signed into law its Public
Health (Alcohol) Act 2018. In May 2023, Ireland signed into law as its Public
Health (Alcohol) (Labelling) Regulations 2023. From May 2026, non-reusable
alcohol containers will be required to include the following labelling.
While feedback from civil society organisations representing public health and consumer protection expressed strong support, industry bodies from across the globe responded opposing the measure. The feedback questioned the compatibility of the Irish Regulations, and warning labelling in general, with EU law in three key ways, which are addressed in turn below.
Legal objection 1: The Irish rules constitute a discriminatory barrier to free movement
National labelling rules fall within the scope of the FIC Regulation, adopted under the competence the EU shares with Member States in the internal market.
In respect of matters not “specifically harmonised” by the FIC Regulation, there appears to be minimum harmonisation: Article 38(2) permits Member States to adopt certain national measures. Health warnings are not explicitly mentioned in the FIC Regulation, which might suggest health warning labelling is not “specifically harmonised”. Therefore, Member States may introduce national measures providing these do not undermine the protection in the FIC Regulation and are not contrary to general Treaty provisions.
In respect of matters which are “specifically harmonised” by the FIC Regulation, there appears to be maximum harmonisation: a declared desire to create uniform protection; an exclusivity clause, which prohibits the sale of non-compliant goods; and a market access clause which precludes national measures unless authorised by EU law. The mandatory particulars have been fully considered and listed, suggesting that mandatory labelling particulars have been “specifically harmonised” and therefore subject to maximum harmonisation. If alcohol health warning labelling is “specifically harmonised”, Member States may not undermine the protection in the FIC but may exceed it subject to general Treaty rules where the FIC Regulation itself allows. In this respect, the FIC Regulation includes a derogation which could allow Member States to exceed the standards under Article 39(1) to adopt rules requiring additional mandatory particulars justified on public health or consumer protection grounds.
Therefore, irrespective of whether health warnings labelling is specifically harmonised or not, under existing harmonisation, Member States are able to move forward with national warning labelling.
Legal objection 2: That the Irish rules are not consistent with existing EU harmonisation
The base protections set out in the FIC Regulation, which Member States may not undermine, are set out in Article 7 FIC as “fair information practices”. Food information shall be “accurate”, “clear and easy to understand”, and “not be misleading” particularly as to the “characteristics of the food” or “by attributing to the food effects or properties which it does not possess”.
Accurate: The Irish labelling is accurate when assessed against ordinary principle of scientific consensus. The evidence that “Drinking alcohol causes liver disease” is well-established, even with relatively lower levels of consumption and increasing with higher consumption. The evidence on the dangers of drinking during pregnancy is also clear. Alcohol intake can affect ability to conceive; brings about pregnancy complications; and interferes with foetal development known as foetal alcohol spectrum disorders, including low birth weight, small for gestational age and preterm birth. No amount of alcohol is considered safe during pregnancy. There is also well-established evidence that “There is a direct link between alcohol and fatal cancers”. Alcohol is classified as a group 1 carcinogen by the WHO International Agency for Research on Cancer as there is a proven causal link between alcohol and at least seven cancers. The risks arise irrespective of the type of alcohol consumed, exist at lower levels and increase with higher consumption.
Clear: The requirement that information is “clear” relates to legibility and visibility. The Irish warnings are likely to meet this requirement not least as they appear against a white background, are within a black box and have a minimum size.
Not misleading: The Irish labelling is also not misleading. In line with broader consumer protection in the internal market, compliance with information rules is assessed against the behaviour of the “average consumer who is reasonably well informed and reasonably observant and circumspect taking into account social, cultural and linguistic factors”. This notional average is an active player in the market who reads information, has background knowledge, is critical towards information, does not take information literally, and will not be misled easily if sufficient information is available. This average consumer is likely to understand the meaning in the labelling. Indeed, the pregnancy warning simply advises women not to drink during pregnancy as per national health guidance. The message that “There is a direct link between alcohol and fatal cancers” communicates association with fatal cancers but does not go as far as communicating a direct causal relationship notwithstanding the well-established evidence on causation. The warning that “Drinking alcohol causes liver disease” is not misleading as liver disease occurs with even relatively lower levels of consumption.
Legal objection 3: That the Irish rules are not proportionate
National alcohol labelling must also be proportionate, which it is when it is suitable and necessary to achieve its objective.
Legitimate objective: The primary objective for health messaging labelling is to inform consumers. While informing consumers appears to be the primary objective, this is part of a broader, secondary objective of reducing consumption. As the Irish Regulations have been introduced under the Article 39 derogation, the objectives are limited to “the protection of public health” and “the protection of consumers”. Alcohol control clearly falls within these broad grounds as the CJEU has consistently held that combating alcohol-related harm is an important and valid goal.
Suitability: Under the suitability limb of proportionality, it is necessary to determine whether the proposed labelling can attain its objectives of informing consumers and contributing to reduction in consumption as part of a broader suite of measures. In respect of the primary objective, evidence demonstrates that there is a deficit of knowledge about the health consequences of alcohol consumption and labelling informs consumers. Studies show that alcohol health warnings specifically lead to increased knowledge of health risks, including cancer, liver disease and pregnancy. Indeed, EU law already requires certain food products to be labelled with health warnings. As regards the secondary objective, there is also evidence supporting the contribution of labelling to reduction in harms and consumption.
Necessity: Under the necessity limb of proportionality, it must be determined whether a less intrusive measure can be equally effective as the proposed labelling to attain the objectives. Other measures are not equally effective. Labelling is available at both the point of purchase and point of consumption. Labelling is available on every container. It is targeted so that everyone can see the label when they see alcohol. It mitigates the effect of promotional marketing messaging on labelling. Ongoing costs are minimal. Moreover, the CJEU has consistently held that labelling is less restrictive than other interventions.
Moving towards effective alcohol health warning labelling
The objections raised by industry, that EU food law is a barrier to national rules on alcohol health warning labelling, are legally unsustainable. Therefore, in the absence of EU level action, Member States must take responsibility for moving forward independently. Let us hope the rest of the EU follows Ireland’s lead.
Nevertheless, EU institutions must also support Member States to tackle alcohol-related harm. Tides appeared to be turning with Europe’s Beating Cancer Plan, in which the Commission committed to introduce proposals on alcohol health warning labelling by the end of 2023, but the deadline has passed with no formal action. Let us also hope the EU decides to prioritise the health of consumers over the interests of economic actors.
Arguably a MS must still respect the procedural requirements set in Art's 39 and 45.
ReplyDeletePlus, bc of the free movement clause in the Reg, CIA-Securities type of legal consequence might be attached to the breach of those provisions.