'On-hold' botanical claims - EU challenge

Last month, the Court of Justice of the European Union (CJEU) delivered a judgment in case C 386/23 on the approach of the European Commission in relation to ‘on-hold’ health claims on botanical substances under the Nutrition and Health Claims Regulation 1924/2006 (NHCR). The full judgment is available here.

This case challenged the European Commission’s lack of movement on ‘on-hold’ botanical claims and whether NHCR Article 10, which permits the use of only authorised health claims, would strictly apply. Article 10(1) NHCR requires that only specific authorised claims may be used, Article 10(3) NHCR provides that any reference to general, non-specific health benefits of a nutrient or food must be accompanied by a specific authorised health claim.

The NHCR sets the legal framework for nutrition and health claims made on foods within the European Union (EU) and is retained EU legislation in the UK and amended by the Nutrition (Amendment etc) (EU Exit) Regulations 2019 and the Nutrition (Amendment etc) (EU Exit) Regulations 2020 that transferred responsibilities from EU organisations involved in the risk assessment and risk management processes covered by nutrition legislation to bodies in Great Britain (GB).

The Article 13.1 On-Hold Register lists claims for botanicals in foods that have neither been authorised, nor rejected, hence they are called ‘on-hold claims’. In 2012, the European Commission created an ‘on-hold’ list of pending health claims and allowed their use in the EU under the transitional provisions from Article 28(5) of Regulation 1924/200, until a final assessment.

‘On-hold’ claims are still under consideration in the EU. However, from 1 January 2021 GB has its own system for authorising claims separate from the EU authorisation system. Despite a call for evidence in the UK, there’s been limited progress by both Europe and the UK in progressing to approval or refusal of these ‘on-hold’ claims.

Details of case

The German company Novel Nutriology GmbH advertised a food supplement containing saffron and melon juice extracts, with health claims indicating that the product could improve mood and reduce fatigue and stress due to the presence of these botanicals. A German association, the Verband Sozialer Wettbewerb eV (VSW), challenged the legality of these claims before the German courts, arguing they violated Article 10 of Regulation 1924/2006, as the claims weren't authorised at EU level.

Proportionate?

The question was raised as to whether this prolonged suspension could effectively prevent companies from obtaining specific authorised health claims for botanical substances and whether this might constitute a disproportionate restriction on the freedom to conduct a business, (Article 16 of the Charter of Fundamental Rights of the European Union). Companies marketing botanicals could arguably face uncertainty and potential competitive disadvantages.

The CJEU held the prohibition of using unauthorised health claims did not disproportionately restrict the freedom to conduct a business. According to the CJEU, this prohibition doesn’t prevent companies from placing foods containing botanicals on the EU market, but it only prohibits their advertising with unauthorised and unassessed health claims.

Justified?

It was queried if there was an 'unjustified difference' in treatment of companies marketing botanical substances who couldn't get new health claims authorisation, compared to the companies whose health claims applications were evaluated and authorised and who can use them in advertising; also, those who submitted an application for a health claim before 19 January 2008 under Article 28 ‘transition’ provisions. Under that provision, health claims which hadn't been the subject of an evaluation and authorisation in a Member State may continue to be used provided that an application was submitted before 19 January 2008, hence the ‘on-hold’ list.

The CJEU didn’t really address this stalemate but rather simply referenced the primary objectives of public health and consumer protection. Furthermore, all health claims, including those relating to botanicals, must undergo the same assessment procedure to make sure they’re scientifically verified.

Conclusion

A challenge of this sort is well overdue. There's been a systematic regulatory impasse and lack of flexibility in authorisation and approvals of claims for some time and the impression is of a more entrenched prescriptive and precautionary approach being taken in Europe. The ruling was not unexpected in that the failure of the EC to make any real progress in evaluating health claims for botanical substances still didn't allow companies to use unauthorised claims. However, it's hoped that the UK whilst aligning with European markets might be more progressive in relation to the authorisation and application of claims and new product development. 

UK - How to use an ‘on-hold’ botanicals health claim?

In the UK, the Department of Health and Social Care oversees the 'on-hold' register. The register is updated periodically to reflect the latest status of health claims under review. 

‘On-hold’ claims do not provide legal certainty, but they provide the ability to use the claim whilst it is being considered by the regulator; this means food manufacturers must stay updated on the status of these claims and be prepared to adjust their marketing if the claim is eventually rejected.

There are certain conditions that must be met if you decide to use an ‘on-hold’ claim:

• The claim must be on the on hold register - (A Nelson & Co Ltd t/a rescueremedy.co.uk, 11 March 2015 - there were no ‘on-hold’ claims for the relevant ingredients).
• The claim must be supported by scientific evidence demonstrating its validity, which must be robust, credible, and not misleading to consumers (Pharma Nord (UK) Ltd, 10 December 2014, New Nordic Ltd, 14 October 2015, provided insufficiently robust evidence to substantiate the claim).
• As with other claims, the use of an ‘on-hold’ botanic health claim would need to comply with applicable NHCR requirements. Claims must have the same meaning for consumers as that of the on hold claim. (Pharma Nord (UK) Ltd, 10 December 2014, New Nordic Ltd, 14 October 2015 sought to change the wording of an “on hold claim” in advertising which changed its meaning; (ARJS Holding Ltd, 11 May 2022) an over-flex of the on-hold claim and lack of substantiating evidence).
• The claim must not mislead consumers about the health benefits of the food product, so should be clear, accurate and not exaggerate the potential effects. Care should be taken not to delete or change the word “normal” if it’s used in claim wording for one that might change the meaning of any claim.
• The claim must comply with the guidance on nutrition and health claims provided by the DHSC, which includes adhering to any specific conditions outlined for the use of 'on-hold' claims.
• Hold evidence that the product contains the amount required of a nutrient or ingredient to meet the conditions of use of the relevant authorised claim. Equally, if there’s a portion requirement, to make clear the quantity that must be consumed ( (LA Muscle Ltd, 31 October 2012) the ASA ruled that ads for a chewing gum didn’t make clear that four pieces of the product were required to be consumed in order to achieve the intake of thiamine necessary to make the relevant claim).
• The claim must be made in relation to the relevant nutrient or food for which it has been authorised, rather than for the product as a whole.
• Be aware of the effect of any visual claims - using before and after photographs in marketing communications for food or food supplements is likely to be problematic if the visual claims implied by the photos go beyond the meaning of an authorised or ‘on-hold’ claim. Also, changes to font to change emphasis can equally change the way a claim may be interpreted by the consumer.
• Provide any additional information as required by the conditions referenced by the claim.

Making unauthorised health claims can lead legal action, fines, and damage to brand reputation.  

If in doubt please get in touch with our food team here at Mills & Reeve to advise you.