Update on EU evaluation of health claims
By Gemma Mainland (FoodLegal Consultant)
FoodLegal Lawyers and Consultants
© Lawmedia Pty Ltd, November 2015
On 7 October 2015, the European Commission published a Roadmap update on an ongoing evaluation of the EU Nutrition and Health Claims Regulation. The evaluation focuses on two key aspects of the regulation: nutrient profiles and health claims on plants and their preparations added to foods. This article discusses the evaluation progress and draws some analogies between the Australian and European regulations.
The EU Regulation
Regulation (EC) No 1924/2006 (the EU Regulation) has many similarities with Standard 1.2.7 (and new Schedule 4) of the Australia New Zealand Food Standards Code (the Food Standards Code).
Both the Australian and the European regulations divide claims into health claims and nutrition content claims, with each setting requirements which must be met in order to make claims.
For a more comprehensive discussion of the differences and similarities between the Australian and European systems, see our June 2015 article “Comparing permitted health claims in Australia and the European Union”.
The EU Regulation was introduced in 2006 in a bid to harmonise a claims system throughout the EU.
The original objectives of the regulation were set out as follows:
For Regulation on health and nutrition claims in general:
- “To ensure a high level of consumer protection and to facilitate healthier food choices;
- To improve the free movement of foods with nutrition and health claims within the internal market and to increase legal certainty for economic operators; and
- To ensure fair competition when nutrition and health claims are being used and to promote and protect innovation in the area of foods.”
For regulating plants and their preparations:
- "To ensure that consumers are correctly informed on nutritional/health value of plants and their preparations contained in food and to allow them to make an informed choice on a healthy diet;
- To ensure that foods containing plants and their preparations that are placed on the market are safe; and
- To ensure the free movement of foods containing plants and their preparations within the internal market.”
Scope of evaluation
The Roadmap sets out the purposes and goals behind the evaluation and the next stages of the project, which is planned to commence in January 2016 and be completed by June 2017.
While the evaluation will touch on other regulatory aspects as necessary (such as safety requirements), the EC has intentionally excluded from the evaluations scope other aspects of the health claims regulation, beyond the two aspects above (nutrition profiles and health claims for plants). This is because the list of authorised health claims came into application in December 2012, resulting in a full evaluation being seen as “premature”.
Both of the key areas featured in the evaluation are ones which have diversified the regulatory scope beyond the original remit.
As well as regulating claims, and requiring claims to be based on scientific evidence, the EU Regulation compels the EC to set nutrient profiles.
These nutrient profiles would specify maximum levels in foods of nutrients such as sugar, salt and fat. If a food product contains levels above these maximums, it would be prohibited from making health claims, and limited in which nutrition claims could be made.
They are intended to ensure consumers are not misled as to the overall nutrition quality of products displaying health and nutrition claims.
However, despite an original deadline of 2009 for the introduction of nutrition profiles, these have yet to be introduced.
Nutrition profiles are similar to the Nutrient Profiling Scoring Criterion (NSPC) contained in Standard 1.2.7 of the Food Standards Code – for more discussion on the NPSC, see previous FoodLegal Bulletin articles:
- Five tips that might help with the Nutrient Profiling Scoring Criterion (April 2015)
- Is the NPSC that bad? A case study demonstrating how the NPSC works (March 2013)
In June 2015, the European Parliament’s Legal Affairs committee voted against an amendment that would abandon the introduction of nutrition profiles. However, the European Commission’s evaluation commencing in January 2016 will consider the following issues regarding nutrition profiles:
- The impact of the delay in introducing the nutrient profiles (including on nutrition and health claims, other health initiatives and the trade of food);
- Alternatives to introducing nutrient profiles;
- Whether updates are needed to the nutrient profiles scheme to account for regulatory changes since 2006 (including the new EU Regulation of Food Information to Consumers); and
- The approaches taken by Member States to make up for the lack of EU level nutrient profiles.
Plants and their preparations used in foods
The second key area considered in the evaluation comes from a lack of EU-wide harmonisation on legislation relating to plants and their preparations used in foods.
The EU Regulation requires scientific evidence “at the highest possible standard” to substantiate any health claim sought to be used on a food product. This must include human studies – evidence from traditional use (that is, evidence gained over time based on actual consumption) alone is considered insufficient.
However, evidence of traditional use can be used in establishing claims for herbal medicinal products.
The classification of a product as a food or as a medicine occurs by Member States on a case-by-case basis. As a result, the same product can be classified as a foodstuff in one Member State and a medicinal product in another.
A second issue highlighted in the update report comes from the fact that a health claim must be substantiated before any safety consideration is conducted by EFSA, leading to concern among Member States that health claims are being authorised prior to safety aspects being assessed.
The evaluation notes that while a list of EU permitted health claims for plants and their preparations exists, not list of permitted plants and plant preparations for use in food exists.
The European Commission evaluation, commencing in January 2016, will consider the following issues regarding plants and their preparations:
- How well the objectives of 2006 Regulation are being met;
- Costs of authorisation procedures for small and medium size enterprises;
- Alternatives to the current provisions;
- How relevant is the 2006 framework to current needs, trends and market evolution;
- How coherent is the 2006 Regulation to other EU legislation on plants and their preparations (including use with traditional herbal medicinal products);
- The merits and disadvantages of the current governance; and
- The merits and disadvantages if the introduction of list of plants and their preparations.
The evaluation will take place from January 2016 and is intended to be completed by June 2017, with the following anticipated timeline:
- External study – to occur in first half of 2016
- Open public consultation – intended in second half of 2016
- Stakeholders consultation – also towards second half of 2016.
This is general information rather than legal advice and is current as of 11 Nov 2015. We therefore recommend you seek legal advice for your particular circumstances if you want to rely on advice or information to be a basis for any commercial decision-making by you or your business.