According to Article 32 of Regulation (EC) No 1333/2008 all food additives permitted before 20 January 2009 should be subject to a new risk assessment by the European Food Safety Authority (EFSA). The programme for the re-evaluation of approved food additives has been set up by Commission Regulation (EU) 257/2010.
Silver (E 174) and Gold (E 175) are included in the programme for the re-evaluation of food additives. In order to ensure an effective re-evaluation of Silver (E174) and Gold (E175), it is important that EFSA acquires from interested parties all necessary data (published, unpublished or newly generated).
The purpose of this call for data is to offer all interested parties and stakeholders the opportunity to submit any available documented information, published or unpublished, on Silver (E 174) and Gold (E 175) used as food additives relevant to the specific areas indicated below in accordance with the Guidance on submission of food additive evaluations by the Scientific Committee on Food.
EFSA kindly asks governments, interested organisations, universities, research institutions, companies and other interested parties to submit information on Silver (E 174) and Gold (E 175) relevant to the specific areas indicated below.
- Specifications of the finished food additive (including particle size and particle size distribution);
- Information on the manufacturing process, including purification and preparation of the product to be commercialised and analytical/production controls, relevant to their uses (tiny sheets, powder, flakes for edible purposes);
- Information of analytical methods for determination in food and drinks;
- Information on the human exposure to the food additive from the different types of food these are permitted (e.g. consumption pattern and uses, actual use levels and maximum use levels, frequency of consumption and other factors influencing exposure);
- Data on toxicokinetics / ADME (Absorption, Distribution, Metabolism, Excretion) and toxicity;
- Data on allergenicity or hypersensitivity (e.g. pruritic eruption, etc) that can result from the use of the food additive (e.g. consumption of gold-containing liquors, silver-coated confectionery, etc).
Process of the call for data
The above information needs to be submitted electronically to EFSA by 24 August 2011 at the latest. The interested parties are invited to contact EFSA for further clarification, if required.
Confidentiality and unpublished data
Specific issues relating to confidentiality of the data provided should be discussed between the owners and EFSA. In application of the Article 8.4 of Regulation 257/2010, following a proposal from EFSA, the Commission will decide after consulting the interested business operator and/or the other interested parties which information may remain confidential and shall notify EFSA and the Member States accordingly.
Please forward all electronic correspondence, including enquiries to the following e-mail address: foodadditives [at] efsa.europa.eu
Hard copies can also be sent to the address below:
ANS Unit, Food Additives
European Food Safety Authority
Largo N. Palli 5/A