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Tribulus terrestris L. is a plant from the Zygophyllaceae family whose use in food supplements is authorised in various countries of the European Union. In its natural form, it contains various active substances, the most notable of which are steroidal saponins, b-carboline alkaloids, flavonoids and lignanamides. Tribulus terrestris' toxicity to animals has been widely documented throughout its history as a medicinal plant and it has been reported to have negative neuronal, muscular, hepatic and renal effects. Some countries consider using parts of the Tribulus terrestris plant to produce food supplements to be unsafe, so they do not allow such supplements to be sold. This is reported through the European Rapid Alert System for Food and Feed (RASFF). The Scientific Committee has conducted a risk assessment with the aim of determining whether consuming fruit, plant shoots and extracts from Tribulus terrestris in food supplements is safe, concluding that there is insufficient toxicological data to assess how safe using parts from the Tribulus terrestris plant in food supplements is. In any case, the maximum daily quantity of Tribulus terrestris in food supplements should not exceed the dose used for pharmacological purposes. The part of the plant used, whether it was extracted or prepared in some other way, as well as its saponin content, should all be made clear on the supplement itself. ; ES; en; pfefsa@msssi.es

The company Seprox Biotech S.L. has applied for authorisation to market synthetic hydroxytyrosol in the European Union, for addition, as an ingredient, to oils, fats and fruit and vegetable juices. This ingredient has no history of use in the European Union prior to 1997 and therefore comes within the scope of Regulation (EC) No 258/97 concerning novel foods and novel food ingredients. The Scientific Committee of the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) is of the view that, on the basis of the information provided, there is no indication that the consumption of synthetic hydroxytyrosol under the conditions proposed by the applicant (involving its addition, as an ingredient, to oils and fats to be consumed uncooked and to fruit and vegetable juices) can have adverse effects on health. The Committee therefore concludes that the novel food presented by Seprox Biotech S.L. for assessment fulfils the criteria for acceptance laid down in Regulation (EC) No 258/97 concerning novel foods and novel food ingredients. ; ES: en: pfefsa@msssi.es

Article 9.3 of Directive 2009/54/EC of the European Parliament and the Council, of 18 June 2009, on the exploitation and marketing of natural mineral waters establishes that Member States may adopt provisions that regulate the use –both on packaging or labels and in advertising– of indications referring to the suitability of a natural mineral water for infant food. However, Royal Decree 1798/2010 of 30 December, which regulates the exploitation and marketing of natural mineral waters and spring waters bottled for human consumption, and transposes the Directive, has not developed the criteria under which the indication "Suitable for the preparation of infant food" set out in Annex III can be used for natural mineral waters from the national territory. The Executive Director of the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) has requested that the Scientific Committee establish the criteria necessary to apply the indication "Suitable for the preparation of infant food" to natural mineral waters. In the proposal of the criteria to use the special indication "Suitable for the preparation of infant food" for natural mineral waters, note was taken mostly of the following: (.) (.) (.) 1. Natural mineral waters using the special indication "Suitable for the preparation of infant food" must meet the specifications on the chemical parameters laid out in Annex IV, Paragraph 1, Part B of Royal Decree 1798/2010 and Regulation (EU) No 115/2010. 2.They must also meet the organoleptic and purity conditions specified in Annex I of Royal Decree 1798/2010. 3.In addition to that established in Points 1 and 2, natural mineral waters using the special indication(.) ; ES; en; pfefsa@msssi.es

In recent years, the number of events of Genetically Modified Organisms (GMO) authorised in the European Union to be used as food or feed has notably increased, particularly in the case of genetically modified soya. The number has grown from September 2008, when t here was only one authorisation, Mons anto Company's Roundup Ready® soya, to seven different events currently authorised: 40- 3-2 soya, MON89788 soya, MON87701 soya, A2704-12 soya, A5547-127 soya, 356043 soya and MON87701 x MON89788 soya. In order to know the possible presence of these varieties of soya in products on the market and to test the degree of compliance with the regulations in force, the National Food Centre (CNA) under the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN), has conducted a study on 28 product samples acquired on the Spanish market. The complete GMO analysis process consisted of the homogenisation of the sample, the extraction and purification of DNA by means of the CTAB method (cetri monium bromide), in order to subsequently carry out the detection, identification and quantification of the genetically modified soya content by means of the polymerase chain reaction (PCR) technique and real time PCR (RT-PCR). The results obtained showed the presence of trans genic sequences in 25 % of the samples analysed. The presence of 40-3-2 soya was identified in three of them, and one simultaneously contained 40-3-2 soya and MON89788 soya. The results have shown that no type of infringement has been revealed since in no case were the levels of genetically modified soya found to be above the legal limit of 0.9 %. ; ES; en; pfefsa@msssi.es

Phenylbutazone is a veterinary medicine belonging to the family of non-steroidal anti-inflammatory drugs (NSAID), and is not authorised to be used in the treatment of animals destined for the human food chain. Following the recent identification in the European Union of horsemeat in processed products which, according to the label, only contained beef meat, the European Commission published Recommendation 2013/99/EU on a coordinated control plan with a view to establish the prevalence of fraudulent practices in the marketing of certain foods. In addition to the control of the presence of horsemeat in food products marketed or labelled as containing beef (Action I), the recommendation includes the control of phenylbutazone in horsemeat destined for human consumption (Action II). To respond to this Recommendation, the National Centre for Food (CNA) of the Spanish Agency for Food Safety and Nutrition (AESAN) has set up and validated in accordance with Commission Decision 2002/657/EC an analytical method of confirmation based on LC-MS/MS, with a Decision Limit (CCa) of 2 μg/kg. The method developed is based on an acidic acetonitrile extraction, followed by a liquid-liquid extraction and subsequent solid phase extraction (SPE) with C18 cartridges. Lastly the determination is made using LC-MS/MS with an electrospray probe in negative mode (ESI-). Quantification uses an external calibration curve without matrix. In accordance with Recommendation 2013/99/EU, a total of 108 samples were taken from horse muscle in ten different Autonomous Regions in Spain during March. The samples were all analysed at the CNA and no traces of phenylbutazone were detected in any case. ; ES; en; pfefsa@msssi.es

Campylobacteriosis is a foodborne disease that affects humans mainly due to manipulation and consumption of broiler meat contaminated with different species of Campylobacter. The infection can also be acquired through contact with carriers and environmental exposure. The main reservoir for Campylobacter spp. are birds, along with cattle, sheep, pigs, rodents, cats and dogs and wild mammals and birds. The reservoir spectrum varies according to the species: C. jejuni is widely spread whilst C. coli is more frequently isolated from pigs. Primary acquisition of Campylobacter spp. from animals occurs after birth and although it can be a cause of morbi-mortality in these animals, in most cases colonization leads to a state of permanent carrier. The last European Food Safety Authority report on zoonosis, zoonotic agents and foodborne outbreaks registered in 2010 shows that Campylobacter spp. is still the foodborne pathogen responsible for the largest number of cases. In the European Union (EU), the notification rate increased from 45.6 per 100,000 in 2009 to 48.6 per 100,000 in 2010. Remarkably the notification rate of confirmed campylobacteriosis has shown a growing trend in the last five years (2006-2010), especially since 2008. Campylobacteriosis causes acute enterocolitis with discomfort, fever, severe abdominal pain aand aqueous and/or bloody diarrhea. The incubation period varies from 1 to 11 days (usually 1-3 days). In most cases, the diarrhea is self-limiting. Bacteraemia occurs in less than 1% of the patients with enteritis and provoke after-effects like rheumatoid disorders or peripheral neuropathies (Guillain-Barré syndrome). Control strategies to reduce the burden of Campylobacter spp. in broiler meat must be based on the strict implementation of Good Hygiene Practices (GHP) and the Hazard Analysis and Critical Control Points (HACCP) system along the whole food chain. ; ES; en; pfefsa@msssi.es

In the EU, food irradiation is regulated by two Directives. Directive 1999/2/EC regulates general and technical aspects for carrying out the process, labeling of irradiated foods and the conditions for authorizing food irradiation and Directive 1999/3/EC provides a positive Community list of foods and food ingredients authorized for treatment with ionizing radiation. So far, this list contains a single food category: dried aromatic herbs, spices and vegetable seasonings, and the authorized maximum absorbed dose is 10 kGy. In Spain, the specific regulation for the treatment of food with ionizing radiation, Royal Decree 348/2001, does not authorize the processing of foodstuffs of animal origin and only allows the treatment of dried aromatic herbs, spices and vegetable seasonings. Nevertheless, taking into account different documents published by the FDA (Food and Drug Administration) and the EFSA (European Food Safety Authority), it can be concluded that meat irradiation might be an effective tool to reduce the content of pathogenic and spoilage microorganisms not considered by Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs. In regard to potential toxicological considerations, foods irradiated in the range established by the legislation seem to be safe and nutritionally suitable. However an increase in quantity and variety of irradiated foodstuffs in the European Union is bound to predictably increase their daily intake in all population ranges and therefore it would be necessary to review the current studies to determine the actual risk due to a larger and ampler intake of radiolytic compounds. ; ES; en; pfefsa@msssi.es

Aflatoxins are toxic metabolites produced by some species of molds belonging to the genus Aspergillus which grow on plants and vegetable-origin foods. Among the aflatoxins that can be found (B1, B2, G1, G2, M1 and M2), from a food safety point of view the most remarkable is aflatoxin B1, because it is the most prevalent in foods and toxic for humans. Due to the toxicity of these substances and to protect consumers' health, the European Union has stated maximum residue limits (MRL) for aflatoxins in foods, in the Regulations (EC) No 1881/2006 and (EU) No 165/2010. MRL have been established for aflatoxin B1 and the sum of B1, B2, G1 and G2 in different foods, including those in which contamination with these kind of toxins is more frequent and can be more dangerous for human health. The Spanish Royal Decree 475/1988 (Real Decreto, 1988), approved before the Regulation (EC) No 1881/2006, sets MRL for the aflatoxins in food for human consumption; 5 mg/kg for aflatoxin B1 and 10 mg/kg for the sum of aflatoxin B1, B2, G1 and G2. Despite the Regulation (EC) No 1881/2006 includes food which most could usually pose a risk for human health, specific papers have demonstrated the presence of total aflatoxins and aflatoxin B1 in foods not included in the Regulations (EC) No 1881/2006 and (EU) No 165/2010, even at higher concentrations than those set up by the Spanish Royal Decree 475/1988. For this reason, notwithstanding the management measures that are pertinent, the Scientific Committee considers that, while there are no more data about maximum limits for these substances other food samples different than those included in the previously mentioned legislations (as tiger nuts or other doubtful foods regarding their producing conditions) the Royal Decree 475/1988 offers a significant protection for consumers. ; ES; en; pfefsa@msssi.es

The current study evaluates the possibility of increasing the use of hydrogen peroxide (oxygenated water-H2O2) as a processing aid in the processing of hemoderivatives and cephalopods. Hydrogen peroxide is considered to be GRAS (Generally Recognized as Safe) by the FDA (Food and Drug Administration) and non-carcinogenic by the International Agency for Research on Cancer (IARC). In addition, the Scientific Committee on Consumer Products (SCCP) of the European Commission considers its use, up to 6%, in toothpaste to be safe. In various countries, including some of the European Union, the use of this agent in foods has already been authorised, such as in the decontamination of water for human consumption and as a processing aid in intestines. In this report it has been proposed to increase its use in the bleaching of blood, and its fractions, and also on cephalopods due to bacteriostatic effect. Regarding the use of hydrogen peroxide for the processing of cephalopods and hemoderivatives under the conditions proposed by the AFCA (Association of Manufacturers and Distributors of Food Additives and Supplements) and based on the data from the different studies that are brought together in this report, such as the absence of residues and the non-modification of lipid oxidation or proteins, the Scientific Committee concludes that hydrogen peroxide poses no risk to the consumer and can be used, always following the conditions included in this reported. ; ES; en; pfefsa@msssi.es

In fish and shellfish, mercury (Hg) is mostly found in the form of methyl mercury (MeHg), its most toxic form. The highest contents are present in predators. The FAO/WHO (2003) has provisionally established a tolerable weekly intake (PTWI) for MeHg of 1.6 μg/kg of bodyweight. Women of child-bearing age, during pregnancy or breastfeeding, and children are the most vulnerable groups. In view of the impossibility of establishing stricter Hg contents in fish, the European Commission (2008) has urged Member States to draft recommendations in order to protect these groups. Thus, attempts have been made to estimate the portion sizes and consumption frequencies that would provide intakes in consumed fish in Spain lower than the PTWI and therefore can be considered as safe. The available data on Hg and MeHg contents, the estimated intakes and the assessments of exposure to Hg, particularly among consumers belonging to the risk groups, do not recommend any increase in the maximum Hg limits established by the European Union (EU, 2006) for fish. ; ES; es; pfefsa@msssi.es

Food irradiation is authorized in many countries but with different restrictions on the type of food, absorbed dose, etc. The European Union (EU) only authorizes the irradiation of dried aromatic herbs, spices and vegetable seasonings to a maximum overall average absorbed radiation dose of 10 kGy. Some Member States authorize in their respective national legislations the irradiation of other types of foods or food ingredients. Most foodstuffs are irradiated after being packaged. The irradiation of plastic packaging gives rise to free radicals and ions, which affect the polymer as well as the low molecular weight compounds present in the material. The magnitude of the changes that happen, both chemical and physical, depends on the nature of the material, radiation absorbed dose, the surrounding atmosphere, dose rate, temperature, time after irradiation and contact with food simulants. Chemical compounds formed as a result of the irradiation process are called radiolysis products (PRs), which can migrate from the packaging to the food and affect its safety and organoleptic characteristics. In USA, a limited number of food contact materials are authorized, which must meet certain specifications in its legal framework. In the EU, specific measures regarding the conditions to be met by these materials are not developed yet. Pending the development of a specific regulation, this Committee recommends that materials intended to be irradiated should have been subjected to extensive experimental evidence, showing that after the irradiation process no products were formed that may migrate to food and pose a hazard to human health. ; ES; es; pfefsa@msssi.es

In view of the current potential for the application of nanotechnology in the food industry, this report refers to the use of nanomaterials deliberately produced in the laboratory or at an industrial level and known as "engineered nanomaterials" (ENM) for their intentional introduction into the food chain and, therefore, potentially consumed. There is already a great variety of ENM, in particular nanoparticles, nanofibres, nanoemulsions and nanoclays. In the food industry, three main areas have been identified as having potential for nanotechnology to make a positive contribution: primary production, processing and food packaging. Due to their size, ENM often present unique physical and chemical properties, significantly different from those corresponding to the same material at a larger scale, implying that it is not possible to infer their toxicokinetics and toxicity profile by extrapolation from data on their non-nanostructured equivalents. These studies are essential for a correct risk assessment, which can be done using the conventional model, but bearing in mind the specific properties of the ENM. There are many limitations on the completion of the process, particularly the need to have information available about the characterization of the ENM, their bioaccumulation, the possible toxic effects after intake or absorption through other routes, in particular chronically, their long-term repercussions on public health, the application of adequate analytical techniques for this kind of material, etc. In addition, there are no databases with information on ENM in current use or the products containing them. For all these reasons, it is considered necessary to go deeper into all these aspects in order to establish specific legislation to protect consumers from the toxic risks derived from exposure to ENM. ; ES; es; pfefsa@msssi.es

Regulations (EC) No. 853/2004 and No. 854/2004 of the European Parliament and of the Council lay down specific rules for the hygiene and inspection of domestic rabbits for human consumption. Royal Decree 640/2006 lays down the conditions applicable in Spain to the production and sale of food products. For technical, planning and economic reasons, the rabbit production sector has proposed a modification in Royal Decree 640/2006 to allow viscera, other than the stomach and intestine, anatomically connected to the carcase to remain. This would mean an exception to the obligation of their removal as established by Regulation (EC) No. 853/2004, "unless the competent authority authorises otherwise." The conditions for this exception would include full examination (including viscera) of a percentage of animals, to be determined by the official veterinarian according to the food chain information avaible, ante mortem inspection and any other relevant considerations, and, should any abnormalities be detected, a full inspection of all carcases in the lot would be carried out. Despite the existence of health risks, the AESAN Scientific Committee considers that, based on the scientific and technical information available, within the current conditions of rabbit production and as long as the uniformity of the slaughtered lots is guaranteed, inspection through sample-taking is effective and the thoracic viscera and liver remaining in the carcase do not have a significant impact on risk, provided that: 1) the risks associated with carcase and viscera contamination are included in the HACCP plan of each slaughterhouse; 2) the uniformity in terms of health of the lots and traceability of health information is guaranteed and 3) full inspection (carcase and viscera) of about a 5% of the animals slaughtered in each lot, and of all the animals if lesions are detected repeatedly, is guaranteed. ; ES; es; pfefsa@msssi.es