EU – Breaking news on allergens labelling

Last week we had great movement around this topic.

DG Sanco opened a public consultation on Guidelines relating to the provision of information on substances or products causing allergies or intolerances as listed in Annex II of Regulation (EU) No 1169/2011 on the provision of food information to consumers.

The consultation aim is to gather opinions from consumers and stakeholders about the draft document. The consultation will be closed on 4th January 2015.

For the pre-packed foods the rules are quite clear and the main topic is around gluten: the Commission suggest to emphasize not the word “gluten” but the name of the cereal (i.e. wheat, barley, …).

For non pre-packed food, the following Q&A give an idea of what is the line of the Commission and the space given to Member States legislation (see 44.2 FIC Reg.).

Can Member States allow, through national measures, the provision of information on substances or products causing allergies or intolerances used in the manufacture or preparation of a non-prepacked food, only and simply upon request by the consumer?

The provision of allergen information “upon request” is not to be considered as a “means of providing information’. However, in a spirit of a pragmatic approach, indicatively, national measures may stipulate that detailed allergen/intolerance information regarding the manufacture or preparation of a non-prepacked food may be given upon request by the consumer, provided that the food business operator indicates in a conspicuous place and in such a way as to be easily visible, 11 clearly legible and, where appropriate, indelible, that such information can be obtained upon request. This combination would already indicate to the consumer that the non-prepacked food
concerned raises issues relating to allergen/intolerances and that such information is available and easily accessible.

The guidelines should be read in conjunction with the legislation itself. The examples it contains are given for illustration only. The guidelines and examples given in the document cannot be regarded as official interpretation of
the legislation, this being the exclusive reserve of the Court of Justice of the European Union. Moreover it is not a final document, but is better than nothing for our food business operators  in light of the fact that in a week from now the FIC Regulation will enter in application.

Few days before the European Food Safety Authority (EFSA) released a Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes.

The Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) updated its previous opinions relative to food ingredients or substances with known allergenic potential listed in Annex IIIa of 2003/89/EC, as amended. These include cereals containing gluten, milk and dairy products, eggs, nuts, peanuts, soy, fish, crustaceans, molluscs, celery, lupin, sesame, mustard and sulphites. The opinion relates to immunoglobulin (Ig)E- and non-IgE-mediated food allergy, to coeliac disease and to adverse reactions to sulphites in food, and it does not address non-immune-mediated adverse reactions to food. It includes information on the prevalence of food allergy in unselected populations, proteins identified as food allergens, cross-reactivities, the effects of food processing on the allergenicity of foods and ingredients, methods for the detection of allergens and allergenic foods, doses observed to trigger adverse reactions in sensitive individuals and risk assessment methodologies that have been used to derive individual and population thresholds for selected allergenic foods.

The huge opinion (286 pages) has many interesting point, but cannot cut clear two of the main issues linked to the possibility to establish thresholds for labelling purposes: which doses trigger adverse reactions (too many variables) and which methods use to detect allergens.

 

FSA UK – Survey on allergen advisory labeling

The survey examined the type of allergen advisory labelling present on pre-packed processed foods sold in the UK, and aimed to quantify the level of allergens resulting from cross-contamination and establish whether the type of advisory labelling used related to the level of allergen present.

The current regulatory framework within the European Union mandates the declaration of 14 allergens as constituent ingredients (i.e. peanuts, nuts, soybeans, mustard, eggs, lupin, milk, fish, cereals containing gluten, sesame, celery, sulphur dioxide, molluscs and crustaceans) in pre-packed foods. This legislation does not cover unintentional cross-contamination with allergens or the resultant use of advisory labelling.

The FSA introduced ‘best practice’ guidance on managing food allergens in 2006 to assist the food industry in the use of advisory labelling. However, due to the lack of standardisation in allergen risk assessment methodology and inconsistencies in allergen management practices, the application of advisory labelling varies in the way it is presented to consumers.

These variations have led some allergic consumers to believe that different types of advisory statements convey different levels of risk (i.e. ‘made in a factory that also handles X allergen’, versus ‘made on a line that also handles X’ allergen).

It was anticipated that the results of this survey will help to inform the development of proportionate risk based allergen management thresholds (known as action levels). It was envisaged that action levels will be used by the food industry as well as by regulatory and enforcement bodies to inform decisions about allergen management, and enable the appropriate use of allergen advisory statements, such as ‘not suitable for those with X allergy’ on pre-packed foods. Furthermore, it was anticipated that action levels will help food businesses make evidence-based decisions on the use of factual statements about whether or not a food is suitable for consumption by someone with a food allergy.

Five hundred and eight pre-packed processed foods were purchased in duplicate (two samples with identical batch/production codes giving a total of 1,016 products) from a range of retail outlets across the UK, including major and smaller national supermarkets as well as independent retailers. Products with allergen advisory statements and an equal number of comparable products without such statements were purchased.

Samples were tested for the unintentional presence and quantity of one or more of the following four major food allergens: milk, gluten, peanut and hazelnut. These allergens were chosen due to the large number of incidents the FSA received over the past few years and because of their importance to public health.

The survey examined the different types of advisory statements used on pre-packed foods and compared the use of these phrases to the levels of allergens present. It was anticipated this may help to establish whether the use of certain advisory statements are linked to the level of allergen present and indicate whether different types of statements convey different levels of risk to the consumer. In addition, the survey examined whether the suggested advisory labelling statements set out in the FSA’s Best Practice Guidance were being used by industry.

The snapshot nature of this survey and sampling methodology means that it may not be representative of the entire UK retail market; it is therefore difficult to extrapolate findings to the UK retail market as a whole. The main findings are as follows:

Undeclared allergen cross-contamination in the UK is lower than previously found in studies in other countries, notably Ireland and the USA.

The percentage of samples with detectable allergen (both with and without advisory labelling) and where that allergen was not present as an intentional ingredient, were as follows: gluten – 6.1% (33/542); milk – 8.2% (39/474); hazelnut – 2.9% (29/988); peanut – 0.21% (2/950).

The percentage of samples with detectable allergen, where that allergen was not present as an intentional ingredient and which did not carry an advisory label were as follows: gluten 3.3% (18/542); milk – 2.1% (10/474); hazelnut – 0% (0/988); peanut – 0% (0/950).

The percentage of samples in which no allergen was detected but carried an advisory label were as follows: gluten – 19% (97/509); milk – 18% (77/435); hazelnut – 44% (427/959); and peanut – 45% (430/948).

The wording of the advisory label did not reflect the level of cross contamination found (for any of the four allergens across any product category).

A wide variety of different statements were used across the product categories. The most frequently used advisory label was ‘may contain traces’ (38% (418/1106)). The second most frequently used was ‘may contain’ (20.6% (228/1106)).

FSA guidance recommends the use of ‘may contain X’ or ‘not suitable for someone with X allergy’. These two statements were found on 20.6% and 7.2% (80/1106) of products, respectively.

The survey is available here.

(Source: FSA website)