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The European Food Safety Authority (EFSA) is the agency of the European Union (EU) that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain. EFSA was established in February 2002, is based in Parma, Italy and had a budget for 2008 of €65.9 million.

The work of EFSA covers all matters with a direct or indirect impact on food and feed safety, including animal health and welfare, plant protection and plant health and nutrition. EFSA supports the European Commission, the European Parliament and EU member states in taking effective and timely risk management decisions that ensure the protection of the healthof European consumers and the safety of the food and feed chain. EFSA also communicates to the public in an open and transparent way on all matters within its remit.

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Published on: 24 April 2018

EFSA-Q-number: EFSA-Q-2018-00317

Background

According to Regulation (EC) No 1333/2008[1], food additives which were permitted for use in the European Union before 20 January 2009 need to be re-evaluated by the European Food Safety Authority (EFSA). The programme for this re-evaluation is defined by Regulation (EU) No 257/2010[2].

EFSA is currently issuing scientific opinions on the safety of these food additives when used in food as per Annexes II to Regulation (EC) No 1333/2008. The risk assessment approach followed until now by the ANS Panel in the re-evaluation of food additives does not cover their use in food for infants below 12 weeks of age[3]. The ANS Panel has, therefore, issued scientific opinions on food additives (listed in table 1) excluding the re-evaluation of uses for this particular age.

On 31 May 2017, EFSA published a guidance document[4] on the risk assessment of substances present in food intended for infants below 16 weeks of age, enabling the ANS Panel to assess the safety of food additives uses for this population.

In addition, in the ANS Panel opinions on the food additives listed in table 1, there are conclusions and recommendations on data gaps in the risk assessment, concerning food categories for all population groups. These will need to be addressed by additional data to be provided and will need additional evaluation in accordance with the European Commission’s (EC) approach for the follow-up of EFSA’s scientific opinions on the re-evaluation of the safety of permitted food additives[5]. For the sake of efficiency, EC asked EFSA to address the above lack of data in the EFSA calls for data to be launched during its assessment for infants below 16 weeks of age.

In order to ensure efficiency in the process for the completion of the re-evaluation, it is important that EFSA retrieves from interested parties all relevant data for the re-evaluation of these food additives regarding the specific uses. To this end, and in accordance with article 6(3) of Regulation (EU) No 257/2010, EFSA is launching public calls for data.

As a first step interested parties should confirm their interest for the use of the food additives indicated in the table 1 in foods for infants below 16 weeks of age.

As a second step, EFSA will communicate the information needed for each additive and the final deadline to provide the data through specific calls for data for the individual additives.

According to Article 6(5) of Regulation (EU) No 257/2010 where the requested information has not been submitted to EFSA within the set deadlines, the food additive may be removed from the Union list in accordance with the procedure laid down in Article 10.3 of Regulation (EC) No 1333/2008.

Overall objective

The purpose of this call is to offer interested parties (IPs) the opportunity to express their interest to use the food additives listed in table 1 in foods for infants below 16 weeks of age.

Deadline for registering an interest

By 22/05/2018 please send a confirmation in writing to EFSA that you are registering your interest on one or more of the food additives listed in Table 1 for uses in foods for infants below 16 weeks of age. By registering an interest you are confirming that the food additive is in use in food category 13.1.1 or 13.1.5.1 or section B of part 5 of Annex III;

Table 1. List of food additives to be re-evaluated for use in foods for their use in foods for infants below 16 weeks of age.

 

E-number

Name of the food additive

E 170

Calcium carbonate

E 304i

Ascorbyl palmitate

E 306

Tocopherol-rich extract

E 307

α-Tocopherol

E 308

γ-Tocopherol

E 309

δ-Tocopherol

E 322

Lecithins

E 407

Carrageenan

E 410

Locust bean gum

E 412

Guar gum

E 415

Xanthan gum

E 440

Pectins

E 466

Sodium carboxy methyl cellulose, Cellulose gum

E 471

Mono-and diglycerides of fatty acids

E 472c

Citric acid esters of mono- and diglycerides of fatty acids

E 473

Sucrose esters of fatty acids

E 1450

Starch sodium octenyl succinate

 

Submission of information

The confirmation that these additives are in use mentioning the respective category(ies) shall be submitted to EFSA in electronic form and paper version, by letter containing:

  • Reference to the current call and its specific EFSA question number: EFSA-Q-2018-00317
  • Name and E number of the food additive(s) for which you are registering an interest
  • Contact details[6] (name of contact person, name of company/organisation, postal address, e-mail address and telephone number) of the person responsible for the data submission and,
  • if applicable, the list of interested business operators and/or interested parties represented together with their contact details;

Correspondence

Please send all electronic correspondence, including enquiries to: fip [at] efsa.europa.eu

Submissions should be sent to the following address:

European Food Safety Authority

FIP Unit

Via Carlo Magno 1/a

I-43126 Parma

Italy

 

[1] Regulation (EC) No 1333/2008 on food additives, OJ L 354, 31.12.2008

[2] Regulation (EU) No 257/2010, setting up a programme for the re-evaluation of approved food additives in

accordance with regulation (EC) No 1333/2008, OJ L 80, 26.03.2010. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010R0257&from=EN

[3] Opinion of the Scientific Committee on Food on the applicability of the ADI (Acceptable Daily Intake) for food additives to infants (expressed on 17/09/1998)

[4] EFSA Scientific Committee. Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age. EFSA Journal 2017;15(5):4849, 58 pp.  https://doi.org/10.2903/j.efsa.2017.4849

[6] The interested parties shall notify EFSA of any change in the contact details by sending an e-mail to the FIP mailbox (fip [at] efsa.europa.eu).


Call for expression of interest to use certain food additives in foods for infants below 16 weeks of age


Published on: 24 April 2018

A total of 11 enzymes were assessed including alpha‐amylase, endo‐1,4‐beta‐glucanase, endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase as silage additives for all animal species. These enzymes are obtained by fermentation of bacterial or fungi non‐genetically modified production strains. Throughout information regarding the production strains of each product were provided, including the origin and history of modifications and allowing their identification. The identification was conclusive for 8 of 10 production strains. For three of the strains, more information/data would still be required in order to conclude. Three of the amylases are produced by bacterial strains that belong to a species that is considered by EFSA to be suitable for the Qualified Presumption of Safety approach to safety assessment. The identity of the strains has been established and the qualifications were met, and consequently, those products were regarded as safe. For the products derived from fungal strains, the strains or resulting products were tested for the presence of secondary metabolites which could be of toxicological concern. These were found to be below the limits of detection or the strain not capable of producing them. Considering all the information provided by the applicant, the Panel concluded that these products can be regarded as safe for the target species, consumer and the environment. In the absence of data, the Panel could not conclude on the skin and eye irritancy or skin sensitisation potential of the products under evaluation. These products should be considered to have the potential to be a respiratory sensitiser. For some of the products under evaluation, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that they have a potential to improve the characteristic of the silage material; for some other products, the Panel could not conclude on their efficacy.


© European Food Safety Authority, 2015

Enzymes as silage additives


Published on: 23 April 2018

In accordance with Article 6 of Regulation (EC) No 396/2005, Syngenta France SAS submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRLs) for the active substance emamectin in leafy brassica and beans and peas with pods. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the crops under consideration. An adequate analytical method for enforcement is available to control the residues of emamectin in the commodities under consideration. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of emamectin benzoate according to the reported agricultural practices is unlikely to present a risk to consumer health. The reliable end points, appropriate for use in regulatory risk assessment are presented.


© European Food Safety Authority, 2015

Modification of the existing maximum residue levels for emamectin in leafy brassica and beans and peas with pods


Published on: 23 April 2018

The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for extract from tea tree are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State Latvia and presents EFSA's scientific views and conclusions on the individual comments received.


© European Food Safety Authority, 2015

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for extract from tea tree in light of confirmatory data


Published on: 23 April 2018

The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No. 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for isofetamid are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State Belgium and presents EFSA's scientific views and conclusions on the individual comments received.


© European Food Safety Authority, 2015

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for isofetamid in light of confirmatory data