Protein & Amino Acid Claims: What's legal in the world of Food Law?

Protein is now the panacea for all health related foods. Yet despite its global growth showing no sign of a slow down and research publications up over 300%,^[1] for those of us within the EU we have a number of limitations in what we can communicate to the consumer. This article written by Dr Mark Tallon provides an overview of what can be written about protein and its constituent amino acids on-pack following the repeal of PARNUTS.

Market boom

The growth of protein fortification within functional and lifestyle food categories have never been greater. According to Euromonitor protein fortified foods have a global value of $93.5bn in 2016, which is almost 60% of the total fortified and function food market.^[2] One of the most valued segments of that category is the Global Whey Protein Market was valued at $6.1 billion in 2016 and is projected to reach $9 billion by 2022, at a CAGR of 7.6% during the forecast period from 2017 to 2022.^[3]

One of the drivers of protein fortification is the acceptance of protein as a means to impact weight management (both weight loss and muscle gain). This health halo has been applied to everything from Weetabix to Water to Tea’s with its marketing reaching everything from satiety, sports performance and anti-ageing. So given the reach is across generations and market segments what can we legally say on-pack about protein and amino acids in the EU?

PARNUTS

PARNUTS the historical parlance for the foodstuffs for particular nutrition uses (Regulation 2009/39/ec)^[4] provided a framework for a number of specific categories of foods that due to a special composition or manufacturing process distinguished them from normal (ordinary) foods. Some categories such as ‘sports foods for intense muscular effort’ had no specific legislative rules over their composition, labelling, advertising etc. However, others such as are infant and follow-on formulae, processed cereal-based foods, baby foods for infants and young children, food intended for use in energy-restricted diets for weight reduction, foods for special medical purposes and gluten-free foods did.

However, Regulation (EU) 609/2013,^[5] known as the Food for Specific Groups Regulation (FSG) repealed PARNUTS thereby abolishing the concept of dietetic foods other than foods for infants and children, medical foods and total diet replacements for weight control. 

One of the issues following the repeal of PARNUTS is that products such as Sports Foods which want to provide an indication of what gives it its special characteristics, and this for example may include its protein and or amino acid composition. In addition a suitability statement for the group of consumers the product is directed at. Because we cannot rely on PARNUTS for highlighting its special characteristics^[6] or giving a suitability statement^[7]

Lets using the following example to examine the current legislative framework:  ‘Sports Food for Athletes with Whey protein containing L-Leucine’.

Taking this ‘ON LABEL’ statement let us consider the impact of 2 major regulations that as of 20^th July 2016 (repeal of PARNUTS) control such wording (other than the exemptions above e.g. infant foods).

Health claims

The health claim regulation (EC 1924/2006) (HCR)^[8] controls not only claims about the impact of a nutrient/food on a function of health but also nutrition claims such as high protein, low fat, low sugar, contains or high in vitamin x etc. The requirements (dose) for making nutrition claims are contained within the Annex of the regulation.

So if we look at our example wording, ‘Sports Food for Athletes with Whey protein containing L-Leucine’ – It is made up of highlighting a product type (Sport food), consumer group (athletes), nutrition claims (whey protein, L-Leucine).

The calling out of whey protein on-pack would not be an issue under HCR providing the condition of use for a source/contains claim are delivered. The problem here is that in the Annex there are no conditions of use for making a source of/contains amino acid claim. Therefore calling out the Amino Acid on pack could be viewed as an illegal nutrition claim. However, there are some options to be considered before accepting its not possible.

Firstly, to be a nutrition claim, the claim must be considered as implying the food has ‘beneficial’ properties. ^[9]  As such this opens up an issue of legal certainty of when or not a claim is a nutrition claim. Stating on pack wording such as, ‘great source of Amino Acids’ is likely to be perceived to a beneficial effect by the consumer, but is ‘Amino Acids’ a beneficial term? or merely providing information to the consumer in a factual, non-beneficial manner? This is important as recital 4 of the HCR specifically excludes non-beneficial nutrition claims from the scope of the regulation.

Secondly, the HCR does not cover claims that are mandatory under Community or National (Member State) legislation.^[10] Therefore, it would be possible to integrate the term ‘Amino Acids’ and for that matter ‘Protein’ into the legal name (descriptive name) of the food to fall outside of the scope of the HCR.

So despite some restrictions post PARNUTS repeal it remains possible to still call out Protein and its Amino Acid content or indeed Amino Acids levels.

Protein vs. Amino Acids - What Impact of the FIRs                  

If a product is a fortified food, the wording above would fall under the umbrella of the Food Information Regulation (EC No 1169/2011).^[11] As such there are restrictions on the repeating of mandatory information. This typically relates to information within the ‘Nutrition declaration’, and as such should only impact the repeating of the word ‘Protein’, as this macronutrient not listed as a substance that can be repeated under the FIRs. Therefore, under the FIRs protein would only be allowed to be stated in the ingredients list, name of the food and in the nutrition declaration. In order to state ‘Protein’ elsewhere on pack it would need to meet the requirements of a nutrition claim in accordance with the HCR.

Amino Acids are not part of the mandatory nutrition declaration as defined in Article 30(1) as such under the FIRs could only be stated on pack in the ingredients list, a warning under Community or Member State law or within the name of the food. As such the challenges for communicating any information regarding the contents of amino acids and protein (voluntarily) are primarily under the control of the HCR. Therefore, we would have to consider if such a nutrition claim in the case of amino acids are beneficial before declaring on pack. In the case of calling out protein its contents must meet the requirement of a source or high in claim irrespective of the wording being viewed as beneficial or not.

The future

Of course the interpretation of these issues and related regulations differ from Member State to Member State and in the absence of a judgement of the courts based on the facts of each case then a commercial decision is to be made. Given the current BREXIT negations it is unlikely than any case would find its way to the EU courts in relation to UK enforcement action.

However, the aim of this article is not only to highlight the potential restrictions for discussing protein (or its amino acid content) or amino acids since the repeal of PARNUTS but also potential legal arguments against such restrictions. Therefore, there still remains scope under EU food law to discuss and inform consumers about the contents of protein and amino acids but the way such messaging is communicated on-pack and related labelling will be key regarding what legislation applies.

Mark Tallon LLM MA PhD FIFST

Dr Tallon is Managing Director of the food law consultancy Legal Foods Ltd and past chairman of the IFSTs Food Law group. He can be reached at www.legalfoods.com

*The article and its content do not represent legal advice and guidance and food businesses should seek legal council prior to placing products on the market.

References

1. Based on Publications on pubmed.com over the year 2000 -2001 (402 published papers) versus Publications in the year 2015-2016 1624 (Publications in 2000) [search limits Human, Protein Supplementation]

2 Mascaraque, M. Ripe Opportunities for the Global Functional Foods Market: An aging population and growing demand for naturally functional products continue to drive a healthy industry. Accessed online 30^th May 2017 at: http://www.nutraceuticalsworld.com/issues/2016-11/view_features/ripe-opp...