EU releases update on evaluation of health claims regulations
The evaluation considers two specific areas of the EU’s regulatory system: nutrient profiles, and health claims on plants and their preparations added to foods.
Both areas form part of the Regulation (EC) No 1924/2006 (the EU Regulation) which governs nutrition and health claims throughout the EU.
Both of the key areas are ones which have diversified the regulatory scope beyond the original remit.
The EU Regulation
The EU Regulation is similar to Australian legal requirements for health and nutrition content claims set out in Standard 1.2.7 of the Australia New Zealand Food Standards Code (the Food Standards Code).
The EU Regulation was introduced in 2006 in a bid to harmonise the claims system for food products throughout the EU, in order to protect consumers, prevent misleading information and ensure a level playing field for businesses.
On its introduction, the EU Regulation compelled 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 what nutrition claims could be made.
The purpose of the nutrition profiles is to prevent consumers from being misled about the overall nutritional quality of a food.
While the EU Regulation set an original deadline of 2009 for the nutrition profiles to be introduced by the EC, they have still not been set.
The EC stated that the delay has been due to “the complexity of the discussions in relation to scientific issues and potential economic impacts”
The evaluation seeks to 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 evaluation seeks to 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 is planned to commence in January 2016 and be completed by June 2017, with the following steps anticipated to occur throughout the year:
– 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.