EFSA Committees

In the EU until 2003, the European Commission s Scientific Committee for Food (SCF) performed safety evaluations of food additives and contaminants. This task has now been taken over by the EFSA. EFSA s risk assessments and other scientific work are undertaken by its Scientific Committee and nine scientific Panels, each responsible for a different aspect of food and feed safety. The scientific work is also supported by external Scientific Expert Working Groups, each specializing in a specific subject (EFSA 2006). 

Panel on food additives, flavorings, processing aids, and materials in contact with food Panel on animal health and welfare 

Toxicological Risk Assessments of Chemicals A Practical Guide 

Panel on additives and products or substances used in animal feed 

A review of risk assessment in European traditional food has recently been published (Larsen 2006). 

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The TDI values settle by the EFSA in 2005 (Table 3) were different from those calculated by the Scientific Committee for Toxicity, Ecotoxicity and the Environment (CSTEE) in 1998 [134] based on the phthalate migration from soft PVC toys and child care articles, and the available toxicity studies on animals at that time [117, 122, 135], with the following values DBP (TDI of 100 pg/kg b.w./day), BBP (TDI of 200 pg/kg b.w./day), and DiDP (TDI of 200 pg/kg b.w./day), but they... 

The stmcmre-based, tiered TTC approach as outlined by Munro et al. (1996, 1999) is used by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in a procedure for the evaluation of flavoring substances in food, including an acceptance of the general TTC of 1.5 pg/person/day, i.e., the US-FDA Threshold of Regulation (Section 4.13.1). The European Food Safety Authority (EFSA) also uses this approach for evaluation of flavoring substances, except that the general TTC of 1.5 pg/person/day is not accepted (Larsen 2006). 

Similarly, in order to avoid any quantitative estimate, an MOE approach has been recommended by, e.g., JECFA (the Joint FAO/WHO Expert Committee on Food Additives) and EFSA (the European Food Safety Authority) in the assessment of compounds that are both genotoxic and carcinogenic by using a benchmark dose (BMD) approach to estimate the BMDLio (benchmark dose lower limit) representing the lower bound of a 95% confidence interval on the BMD corresponding to a 10% tumor incidence (see Section 6.4). 

EFSA. 2005. Draft opinion on a harmonized approach for risk assessment of compounds which are both genotoxic and carcinogenic. Request No EFSA-Q-2004-020, EFSA Scientific Committee, The European Food Safety Authority, 7 April 2005. Brussels EFSA. http /www.efsa.eu.int/en/... 

EFSA (2006) Guidance of the Scientific Committee on a request from EFSA related to uncertainties in dietary exposure assessment. The EFSA Journal, 438 1-54... 

EFS A (2005) Opinion of the scientific committee on a request from EFSA related to a harmonised approach for risk assessment of substances which are both genotoxic and carcinogenic. The EFSA Journal 282 1-31. http //www.efsa.eu.int/science/sc commitee/sc opinions/1201/... 

EN 1186 Parts 1-15, Materials and articles in contact with foodsmffs - Plastics. Guidelines of the Scientific Committee on Food for an application for safety assessment of a substance to be used in food contact materials prior to its authorisation. Note for Guidance, Chapter II, updated on 13 December 2001. http //www.efsa.eu.int/science/ afc/afc guidance/722/noteforguidancel.pdf... 

In 2004, the European Commission reorganized its nonfood scientific committees following the creation of the European Food Safety Authority (EFSA) and the transfer to the Authority of responsibilities for risk assessment on food-related issues previously carried out by some of the scientific committees. The Commission reviewed and refocused the work of its three remaining nonfood scientific committees and created three new committees Scientific Committee on Consumer Products (SCCP), Scientific Committee... 

As mentioned before, the regulatory evaluation of plant protection products in the EU is carried out by EU-authorities and member states together. The active substances are evaluated on the EU-level whereas the authorization of products falls imder the responsibility of member states. At the EU-level, the European Food and Safety Authority (EFSA) organizes the risk assessment process in close connection with experts from member states and a committee of independent scientists mainly from academia. Based on the outcome of this risk assessment, the European Commission together with representatives from member states... 

Detailed lists of the data required to be evaluated to satisfy inclusion in Annex I of the Directive, or the authorization of a plant protection product are set out in the Directive (Annexes II and III). Annex II data relate to the active substance and Annex III to the plant protection product. These data are submitted to one or more Member States for evaluation. A report of the evaluation is submitted to the European Food Safety Authority (EFSA). Following peer review of the report the EFSA makes a recommendation to the European Commission on whether Annex I inclusion is acceptable. This recommendation is then discussed by all Member States in the framework of the Standing Committee on the Food Chain and Animal Health (SCFA), previously the Standing Committee on Plant Health (SCPH). Where necessary, the Scientific Panel is consulted before the SCFA can deliver an opinion on whether an active substance should be included in Annex I of 91/414/EEC. 

AFL occurrence and concentration data, submitted from 22 European Union (EU) Member States for the European Food Safety Authority (EFSA) risk assessment requested by the European Commission (EC) in 2006, were available for this evaluation. Australia, Brazil, the Islamic Republic of Iran, Japan, Turkey, United Arab Emirates and the United States of America (USA) also submitted data on AFL contamination. In total, the Committee had access to over 100 000 data points for its analyses. Other data on contamination by these toxins have been taken from published literature, but they were not used to calculate dietary exposure because the disaggregated data were not available. Rather, they were used to reinforce the analysis made in the document. 

The Islamic Republic of Iran submitted the results of 6187 AFL monitoring data for 1849 pistachio nut lots (ready-to-eat) consigned to be exported from July 2004 to March 2007 (Secretariat of Iran Codex Committee on Contaminants in Food, 2007). The sensitivity of the analytical method was reported with an LOD of 0.2 pg/kg for AFBi and 0.4 pg/kg for AFT, with 24% of the data reported below the LOD. A linear regression coefficient of 1.13 (similar to the number reported in the EFSA opinion) was applied to estimate the level of AFT in a low number of samples (around 4%) in which AFBi data only were submitted. 

For this evaluation, the Committee considered new toxicological studies that had become available since the last evaluation these included further studies on developmental toxicity, neurotoxicity, immunotoxicity, nephrotoxicity and geno-toxicity and studies on the mode of action of ochratoxin A in the kidney. The Committee also considered the opinion on ochratoxin A in human food published by the European Food Safety Authority (EFSA) in 2006 (European Food Safety Authority, 2006). New data on analytical methods, sampling protocols and the effects of processing were also considered, together with methods of prevention and control and levels and patterns of food contamination. A new dietary exposure assessment was conducted, and the impact of different MLs for cereals was considered. 

The short-term toxicity of ochratoxin A has been extensively reviewed previously by this Committee (Annex 1, reference 153) and by EFSA (European Food Safety Authority, 2006). In summary, the kidney is the major target organ for the adverse effeots of ochratoxin A, and short-term toxicity studies in mice, rats, dogs and pigs have shown dose-dependent and time-dependent development of progressive nephropathy. There are significant sex and species differences in sensitivity of the kidney to the toxic effects of ochratoxin A. Most of the recent shortterm studies on oohratoxin A-induced kidney toxicity have focused on the possible mechanism(s) for its toxio effeots, and these are described below in section 2.2.5. 

The long-term toxicity and carcinogenicity of ochratoxin A have been extensively reviewed previously by this Committee (Annex 1, reference 153 and by EFSA (European Food Safety Authority, 2006). Ochratoxin A produces renal tumours in mice and rats, and, as is the case for short-term toxicity to the kidney, there are marked sex and species differences. Male animals are more sensitive than females, and rats are considerably more sensitive than mice. The Committee previously noted that the long-term effects in rats were preceded by evidence of renal toxicity in 16-day and 13-week studies and that it was unclear whether the malignancy and aggressive nature of the tumours were a secure indication that the mechanism of induction is via deoxyribonucleic acid (DNA) reactivity (Annex 1, reference 153). 

Ochratoxin A is immunotoxic in vitro and in vivo, as described previously by this Committee (Annex 1, reference 153). More recent studies have been described by EFSA (European Food Safety Authority, 2006) and are briefly summarized... 

EFSA (2007) Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA. Opinion of the Scientific Committee. EFSA /., 587, 1-16. 

Several scientific institutions have derived TDIs from toxicological end points by applying an uncertainty factor. The Scientific Panel on Contaminants in the Food Chain (CONTAM) established a TDI for PFOS of 150 and for PFOA of 1.5 pg/kg bwt/day (EFSA 2008). The UK Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) proposed a TDI for PFOS and PFOA of, respectively, 300 and 3,000 ng/kg bwt/day (COT 2006a,b). Furthermore, the German Federal Institute for Risk Assessment proposed a TDI of 100 ng/kg bwt/day for both PFOS and PFOA (BfR 2006). 

Since 1999, the Scienti c Committee on Food (SCF) and the European Food Safety Authority (EFSA) have expressed their opinions on a number of substances found naturally in source materials for avorings and food ingredients with avoring properties, for example, some herbs and spices. According to the Committee of Experts on Flavoring Substances (CEFS) of the Council of Europe (CoE),w these substances may raise toxicological concern. Although these substances... 

European Food and Safety Authority, 2009. Scientific Opinion The Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety—Scientific Opinion of the Scientific Committee (Question No EFSA-Q-2007-124a). EFSA, Brussels. 

Preservatives are one of the 26 major additives categories that are used in the food processing. To ensure that preservatives really do help make foodstuffs safer, their use is subject to premarket safety assessment and authorization procedures. At the European level, the bodies responsible for the safety assessment, authorization, control, and labeling of preservatives and other additives are the European Food Safety Authority (EFSA) and the European Commission Parliament and Council. At the international level, there is a Joint Expert Committee from the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) Joint Expert Committee for Food Additives (JECFA) [2]. 

Alkyl gallates are mainly used to protect fats, oils, and fat-containing food from rancidity that results from the formation of peroxides. Their use as antioxidant additives is regulated by legal authorities in a limited number of foods, with maximum limits in each case. The acceptable PG daily intake (ADI) recommended by the joint FAO/WHO Expert Committee on Food Additives (JECFA) is 0-1.4 mg of additive per kilogram body weight, and the maximum level recommended in foodstuffs is 200 mg/kg [1]. A recent reevaluation by the European Food Safety Authority (EFSA) of PG as food additive has concluded that it is not of safety concern at the current uses and use levels [2]. 

European Food Safety Authority (EFSA) Scientific Committee (2009) The potential risks arising from nanoscience and nanotechnologies on food and feed safety. EFSA J 958 1-39. doi 10. 2903/j.efsa.2009.958, http //www.efsa.europa.eu/en/efsajournal/pub/958.htm. Accessed 24 Oct 2013... 

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