EUROPEAN FOOD SAFETY AUTHORITY

Transcription

1 EUROPEAN FOOD SAFETY AUTHORITY Call for scientific data on food additives permitted in the EU and belonging to the functional classes of emulsifiers, stabilisers and gelling agents Published: 23 November 2009 modified on 05 February 2010 Deadline for step 1: 23 May 2010 No general deadline is defined for step 2 as step 2 will take place at different points in time following the selection by EFSA of the relevant data. Deadline for informing EFSA about additional documents/data, which may become available after the deadline defined for step 1 of this call for data: 31 December Background The Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) has been asked in 2003 by the European Commission to re evaluate all currently permitted food additives in the EU and issue related scientific opinions. Article 32 of Regulation (EC) No 1333/2008 on food additives 2 specifies that all food additives permitted before 20 January 2009 should be subject to a new risk assessment by EFSA. A new Regulation setting the re evaluation programme in accordance with Regulation (EC) No 1333/2008 will be adopted by the European Commission in This Regulation will specify the priorities and the deadlines for the re evaluation. After the food colours, which are currently being re evaluated, another group of food additives to be re evaluated is comprised of the emulsifiers, stabilisers and gelling agents (see table in Annex). In preparation for their re evaluation, existing information on the permitted emulsifiers, stabilisers and gelling agents needs to be collected, collated and summarised. Evaluation of the technical requirements and use of food additives is outside the remit of EFSA and will be undertaken by the European Commission and EU Member States. Overall objective The purpose of this call for data is to offer interested parties the opportunity to submit any available documented information, published or unpublished, relevant to the specific areas indicated below. These submissions will be done in a 2 step process and should be as comprehensive as possible: Step 1: Registration 3 of the contact details of the interested party and description of the information available The interested parties need to register their contact details and provide a list of 1 In the case of invertase, in view of the deadline for the re-evaluation of this enzyme foreseen in the forthcoming Commission Regulation setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives, the deadline for informing EFSA about additional documents/data, which may become available after the deadline defined for step 1 of this call for data is set to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. 3 Any personal data is processed pursuant to Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000, on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data. Personal data will be collected in an internal EFSA database and concern contact references and affiliation information of representatives of organisations submitting information relevant to the safety of the food additives under consideration in this call. The Head of the Unit for Food additives and nutrient sources added to food (ANS Unit) is identified as the controller of the personal data processing. Applicants are able to modify at any time personal data submitted in EFSA s internal database by contacting directly the ANS Unit (foodadditives@efsa.europa.eu). Personal data contained in this system are only accessible by the authorised users of the ANS Unit and the IT Unit of EFSA. Personal data will be erased from the system as soon as these are no longer relevant for the purpose of this call. Concerning the processing of personal data, applicants have the right to have recourse at any time to the European Data Protection Supervisor.

2 documents/data available at the time of this call for a given group of food additives (as defined by EFSA). This information needs to be submitted electronically, using the excel file template defined by EFSA, to the following e mail address: foodadditives@efsa.europa.eu Please provide one excel file per defined group of food additives (the groups are predefined by EFSA as shown in the Annex and can be selected in the excel file from a drop down menu). Therefore, if an interested party wants to submit information related to different groups of food additives, several excel files should be provided. N.B.: some groups can consist of only one food additive and the deadline of the call for data applies only to step 1 Step 2: Submission to EFSA of the data selected by EFSA Following the screening of all submissions received, EFSA will request hard and/or electronic copies of selected documents only. This request by EFSA will not necessarily take place immediately after the receipt of the information provided during the step 1. Timely receipt of such information is important in ensuring that appropriate sciencebased evaluations will be taken into account for the re evaluation of these food additives. Therefore the submission of the selected data should take place within 20 working days following EFSA s request. N.B.: Interested parties can inform EFSA about additional documents/data, which may become available after the deadline defined for step 1 of this call for data, before at the latest. This information needs to be submitted electronically, to the e mail address: foodadditives@efsa.europa.eu. During the re evaluation process, EFSA may request additional information considered to be relevant for the re evaluation of a particular food additives or group of food additives by a new call for data. Information required EFSA kindly ask governments, interested organisations, universities, research institutions, companies and other EFSA stakeholders to submit information on the food additives under consideration relevant to the specific areas indicated below. Safety in use (including the scientific data not previously reviewed in the scientific opinions by the SCF and JECFA, as well as the original study reports evaluated by the SCF and JECFA; safety in use should be understood in the widest possible sense and the relevance of any biological data should be considered); Specifications presently in use, including purity and, when relevant, particle size and relevant physicochemical characteristics and properties; Production methods; Analytical methods available for determination in food; Present use and use patterns (i.e. which food categories and subcategories, proportion of foods within categories/subcategories in which it is used, actual use levels (typical and maximum use levels), especially for those uses which are only limited by quantum satis); 3 In the case of invertase, in view of the deadline for the re-evaluation of this enzyme foreseen in the forthcoming Commission Regulation setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives, the deadline for informing EFSA about additional documents/data, which may become available after the deadline defined for step 1 of this call for data is set to

3 Confidentiality and unpublished data Specific issues relating to confidentiality of unpublished data should be discussed between the owners of the data and EFSA and the Commission shall decide on a proposal from EFSA which information may remain confidential. Contact details All correspondence should be sent only electronically to: foodadditives@efsa.europa.eu

4 ANNEX EU Permitted Food Additives E number E322 E400 E401 E402 E403 E404 E405 E406 E407 E407a E410 E412 E413 E414 E415 E416 E417 E418 E425 E426 Emulsifiers, Stabilisers, Gelling agents Lecithins Alginic acid Sodium alginate Potassium alginate Ammonium alginate Calcium alginate Propane 1,2 diol alginate Agar Carrageenan Processed eucheuma seaweed Locust bean gum Guar gum Tragacanth Acacia gum (gum arabic) Xanthan gum Karaya gum Tara gum Gellan gum Konjac Soybean hemicellulose E432 Polyoxyethylene sorbitan monolaurate (polysorbate 20) E433 Polyoxyethylene sorbitan monooleate (polysorbate 80) E434 Polyoxyethylene sorbitan monopalmitate (polysorbate 40) E435 Polyoxyethylene sorbitan monostearate (polysorbate 60) E436 Polyoxyethylene sorbitan tristearate (polysorbate 65) E440 E442 E444 E445 E460 E461 E462 E463 E464 E465 E466 Pectins Ammonium phosphatides Sucrose acetate isobutyrate Glycerol esters of wood rosins Cellulose Methyl cellulose Ethyl cellulose Hydroxypropyl cellulose Hydroxypropyl methyl cellulose Ethyl methyl cellulose Carboxy methyl cellulose Sodium carboxy methyl cellulose

5 E468 E469 E470a E470b E471 E472a E472b E472c E472d E472e E472f E473 E474 E475 E476 E477 E479b E481 E482 E483 E491 E492 E493 E494 E495 E1103 Cross linked sodium carboxy methyl cellulose Enzymatically hydrolysed carboxy methyl cellulose Sodium, potassium and calcium salts of fatty acids Magnesium salts of fatty acids Mono and diglycerides of fatty acids Acetic acid esters of mono and diglycerides of fatty acids Lactic acid esters of mono and diglycerides of fatty acids Citric acid esters of mono and diglycerides of fatty acids Tartaric acid esters of mono and diglycerides of fatty acids Mono and diacetyl tartaric acid esters of mono and diglycerides of fatty acids Mixed acetic and tartaric acid esters of mono and diglycerides of fatty acids Sucrose esters of fatty acids Sucroglycerides Polyglycerol esters of fatty acids Polyglycerol polyricinoleate Propane 1,2 diol esters of fatty acids Thermally oxidised soya bean oil interacted with mono and diglycerides of fatty acids Sodium stearoyl 2 lactylate Calcium stearoyl 2 lactylate Stearyl tartrate Sorbitan monostearate Sorbitan tristearate Sorbitan monolaurate Sorbitan monooleate Sorbitan monopalmitate Invertase