Brief overview on the Reg. (EU) n. 1169/2011, also known as FIC (“Food information to consumers”).

Following the requests of many of my “non-EU” readers, I publish a brief recap of the new provisions of the Regulation…and some links to useful resources.

As of 13 December 2014, new EU food labeling rules are in force: from this date became applicable the Regulation (EU) n. 1169/2011 on food information to consumers, also known as FIC or FIR Regulation. The aim of the new rules is to ensure that consumers receive clearer, more comprehensive and accurate information on food content, helping them to make informed choices about what they eat. The new Regulation replaces the old Directive 2000/13/EU, which is now repealed.

Some of the key changes to the labeling rules are outlined below:

  • Improved legibility of the information (minimum font size for mandatory information, now 1,2 mm in the most of cases);

  • Clearer and harmonised presentation of allergens (e.g. soy, nuts, gluten, lactose) for prepacked foods (emphasised by font, style or background colour) in the list of ingredients;

  • Mandatory allergen information for non-prepacked food, including those sold in restaurants and cafes;

  • Requirement of certain nutrition information for majority of prepacked processed foods (applicable from 13th December 2016);

  • Mandatory origin information for fresh meat from pigs, sheep, goats and poultry (Reg. (EU) n. 1337/2014);

  • Same labeling requirements for online, distance-selling or buying in a shop;

  • List of engineered nanomaterials in the ingredients.

  • Specific information on the vegetable origin of refined oils and fats;

  • Strengthened rules to prevent misleading practices;

  • Indication of substitute ingredient for ‘Imitation’ foods;

  • Clear indication of “formed meat” or “formed fish”;

  • Clear indication of defrosted products;

  • Clear indication of added water, especially in meat and fish products.

The Regulation was published three years ago and provides a transitional period for exhaustion of stocks for foods placed on the market or labeled before 13 December 2014 (but this does not includes labels).

Despite food business operators have been given three years to ensure a smooth transition towards the new labeling regime for prepacked and non-prepacked foods, the situation is quite to be clear, especially for non-prepacked foods, where there is not a full harmonization and the EU Commission left space to national legislation.

On this side, there is also an ongoing study on the feasibility of a EU database to facilitate the identification of all EU and national mandatory labeling rules in a simple way. This should offer a user-friendly tool for all food business operators and for SME’s, but it will not be ready at least until the second part of 2015.

Recently, on the DG SANCO website, were published Guidelines related to the indication of the presence of certain substances or products causing allergies or intolerances as described in Article 9.1(c) and listed in Annex II of the Regulation. The document is the subject of a public consultation that will end on 4th January 2015 and it covers also some aspects related to non-prepacked foods.

On 31st January 2013, the EU Commission published the first – and until now unique – document of clarification of some specific provisions: Questions and Answers on the application of the Regulation (EU) N° 1169/2011 on the provision of food information to consumers. More Q&A and guidelines documents are expected to be published in the next few months: they will cover different topics, in particular general labeling, nutrition labeling, the QUID (Quantitative Ingredients Declaration) and specific products’ type (i.e. meat and fish).

Warning labels on plant sterols and stanols products

Phytosterol
Phytosterol (Photo credit: Wikipedia)

According to Art. 1 of the EU Regulation No. 718/2013, amending Regulation (EC) No. 608/2004 concerning the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters,

“Article 2 of Regulation (EC) No 608/2004, point 3 is replaced by the following:

‘3. there shall be a statement that the product is not intended for people who do not need to control their blood cholesterol level.’

The precedent form of expression of the statement was positive. Now the European legislator intends to reinforce the provision with the strongest negative expression “the product is not intended for people who do not need to control their blood cholesterol level”.

Basically, it’s more a rewording than a real modification.

The rationale of the decision, is strictly related to the approval of Art. 13 and 14 claims for

” (3)The voluntary inclusion of nutrition or health claims on food labels is governed by Regulation (EC) No. 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (4). Accordingly, Commission Regulation (EC) No. 983/2009 of 21 October 2009 on the authorisation and refusal of authorisation of certain health claims made on food and referring to the reduction of disease risk and to children’s development and health (5), Commission Regulation (EU) No. 384/2010 of 5 May 2010 on the authorisation and refusal of authorisation of certain health claims made on foods and referring to the reduction of disease risk and to children’s development and health (6) and Commission Regulation (EU) No. 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health (7) have authorised health claims relating to the reduction and maintenance of blood cholesterol with respect to foods containing plant sterols and plant stanols, subject to certain conditions of use.

(4) Regulation (EC) No 983/2009 authorised, under certain conditions of use, the following health claims: ‘Plant sterols have been shown to lower/reduce blood choles­terol. High cholesterol is a risk factor in the development of coronary heart disease’ and ‘Plant stanol esters have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease’.

(5) Regulation (EU) No 384/2010 authorised, under certain conditions of use, the following health claim: ‘Plant sterols and plant stanol esters have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.’
(6) Regulation (EU) No 432/2012 authorised, under certain conditions of use, the following health claim: ‘Plant
sterols/stanols contribute to the maintenance of normal blood cholesterol levels’.

(7) The wording of the authorised health claims in combination with the mandatory statement relating to the target group laid down in Regulation (EC) No. 
608/2004 could potentially lead consumers who do not need to control their blood cholesterol level to use the product. Therefore, with a view to ensure consistency of the information provided on the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters, it is appro­priate to amend the mandatory statement laid down in Regulation (EC) No 608/2004 while ensuring that its wording serves adequately the informative purpose for which it was initially introduced.”

About the transitional measures, should be enlightened the Art. 2:

“Food and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters placed on the market or labelled prior to 15 February 2014 which do not comply with the requirements of this Regulation may be marketed until the stocks of the foods are exhausted”