Q&A EU Commission – Allergens – Special labelling provision for rapeseed protein as novel food

Question for written answer
to the Commission 
Rule 117
James Nicholson (ECR) (2nd April 2014)

Subject:  Special labelling provision for rapeseed protein as a novel food

I welcome the forthcoming authorisation of rapeseed protein as a novel food; however, the draft Commission implementing decision contains an unprecedented labelling provision according to which ‘any foodstuff containing rapeseed protein shall bear an easily visible and legible statement that the product containing “rapeseed protein” as a food ingredient may cause allergic reaction to consumers who are allergic to mustard and products thereof’.

If rapeseed protein is considered an allergen, then it should be listed in Annex II to Regulation (EU) No 1169/2011 on the provision of food information to consumers. If rapeseed protein is not an allergen, it should not be subject to a special labelling requirement.

Will the Commission explain why it has proposed a labelling requirement for allergic cross-reaction as opposed to the traditional professional information channels to inform consumers?

Can the Commission confirm that such a labelling requirement has a legal basis in the current novel foods regulation?

Will the Commission take into consideration the European Food Safety Authority’s anticipated report on the occurrence of food allergies in the EU before imposing unprecedented labelling requirements?

Answer given by Mr Borg on behalf of the Commission (29th April 2014)

The European Food Safety Authority (EFSA) considered in its ‘Scientific Opinion on the safety of “rapeseed protein isolate” as a Novel Food ingredient’, adopted on 10 October 2013, that the risk of sensitisation to rapeseed cannot be excluded and that it is likely that rapeseed can trigger allergic reactions in mustard allergic subjects.

Mustard allergens can cause serious and potentially life-threatening reactions in affected individuals. Potentially exposure to the rapeseed protein is much higher than to mustard as it may replace other protein-rich ingredients in a wide range of foods. This change of protein source will not be immediately evident to the consumer. Rapeseed protein, due to its ‘novel nature’, cannot be considered today as a ‘common allergen’. People with mustard allergies have no reason to avoid the wide range of foods that could contain this novel food ingredient, and they will not be checking the detailed ingredient lists. Therefore, the Commission considers that the most appropriate risk management tool is to provide for a specific labelling requirement instead of using the traditional information channels or the labelling regime applicable to common allergens. The legal basis of such labelling is Article 7(2) in conjunction with Article 8(1)(b) of Regulation (EC) No 258/97.

EFSA is currently reviewing and assessing scientific data on allergenicity in Europe, including the evaluation of the Union list of ‘common allergens’. Once available, the Commission will assess the outcome as well the need for updating the Union legislation accordingly. In this regard, the appropriateness of the inclusion of rapeseed protein in Annex II to Regulation (EU) No 1169/2011 could be considered.

(Source: European Parliament website)

Q&A to EU Commission – Labelling of nanomaterials and food additives – Which future for this indication?

The following Q&A is of great interest because enlightens the core of the discussion about nanomaterials. How they will be defined? Will the food additives be exempted from the labelling requirements provided by the FIC Regulation or not?

The two questions are strictly connected, because the definition of nanomaterial and the quantification of what is intended for “nano”, is the necessary premise of the exemption.

Nanotechnologies at the moment are not so used in “food”: most of the applications are in the food additives and in the food contact materials sectors. That is why the debate is so important and is so difficult to find an agreement about the definition of “nano”.

By the way, the definition at the moment  included in the FIC Regulation (n. 1169/2011, art. 2, par. 1, lett. t ) is the following:

“engineered nanomaterial’ means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale.

Properties that are characteristic of the nanoscale include:

(i) those related to the large specific surface area of the materials considered; and/or

(ii) specific physico-chemical properties that are different from those of the non-nanoform of the same material;”

Question for written answer
to the Commission 
Rule 117
Marc Tarabella (S&D) (20th March 2014)

Subject:  Labelling of nanomaterials

Parliament rejected by 402 votes to 258, with 14 abstentions, the draft regulation proposed by the Commission on the labelling of nanomaterials in food products. Why? Because the Commission had excluded food additives from the labelling requirements.

Parliament has thus confirmed the vote of the Committee on the Environment, Public Health and Food Safety (ENVI).

This rejection is a vote in favour of consumers, so that they can be informed of all the nanomaterials in the foods they consume, including food additives.

What is the Commission’s reaction to this and what does it intend to do now?

Answer given by Mr Borg on behalf of the Commission (28th April 2014)

The new requirements on the labelling of ‘engineered nanomaterials’ present in food apply from 13 December 2014 on the basis of the definition laid down in Regulation (EU) No 1169/2011.

The Commission has taken good note of the Resolution of the European Parliament and of the discussions in the Council regarding the draft delegated Regulation on the definition of ‘engineered nanomaterial’. The Commission is currently discussing the options and reflecting on the best way forward so as to adapt the definition in the light of new scientific and technological developments whilst addressing the concerns expressed by the Parliament.

(Source: European Parliament website)