Newsletter. Upon quality commitments JANUARY 2015

Transcription

1 Newsletter JANUARY 2015 In November 2013, Sylvain Tuller, R&D engineer, joined the SAFE team. One of his objectives is to enhance the results derived from effective past efforts. Several lines of research and in-depth analysis have been undertaken. In the first instance, a retrospective analysis of all the available data has been initiated with an aim to show the long term effectiveness of our commitments. Dominique Martel and Sylvain Tuller are going to outline for you just a few of these results. Upon quality commitments It s my pleasure to introduce this SAFE Newsletter which, as always, sets itself off by concentrating on the concept of quality. You all know what commitment and energy we put into accomplishing our goals and reducing the diet factor. Your questions and your ever more defined expectations allow us to carry on making progresses. On the industrial side of things, several improvements have been brought to completion, in particular, regarding the autoclavable products and in the vacuum packing process (an improved cardboard which will allow you to test product quality while still in its vacuum seal). On the packaging side, we shall be presenting the design of our new bags to you, to be implemented over the course of The range of beddings and enrichementenjoyed a great success in 2014, something which confirms the wisdom of our choices. We are now perfecting our offer by proposing, for example, an improved packaging for the beddings used in isolators. I wish all of you an excellent 2015, full of health and happiness. I hope you woken up on Christmas Day to find a stocking filled with plans and projects that you will go on to achieve. SAFE team For more informations, please conctat us Route de Saint Bris 89290, Augy France T: +33(0) info@safe-diets.com

2 Which controls and what are the results? SAFE s will and purpose to master Quality in its products requires a considerable control programme and numerous samples taken. In 2013, SAFE analysed more than 35,000 physical, chemical and bacteriological criteria related to these raw materials and finished products. This commitment to Quality amounts to the simple fact that, on average, each batch of SAFE diet is assessed on the basis of more than 145 analytical parameters. This same analytical control is performed in continuous manner and/or at random; it is carried out in partnership with leading laboratories, each in their respective field (nutritional chemistry, nitrate contaminants, etc.) with authorisation issued by COFRAC [The French Certification body]. It should be said that this important analytical programme is completed by: chemical or bacteriological checks to assess the metrological compliance of the production processes, and by tailor-made studies aimed at assessing innovations that might improve the quality of the products, sometimes conducted in partnership with others. THE ANALYSES The reliability of the tools of research is fundamental to the way biomedical and biological studies should be conducted. Stemming from this, mastering control of the living conditions for animals bred for experimentation and their diet constitutes one of the key links in this chain of control. In order to ensure Stability and Quality in the diets distributed to the laboratory animals, SAFE produces diets that implement important procedures to ensure Food Quality and Safety: the training of personnel, the choice of suppliers, hygiene, the standardisation of processes, Quality Control, Quality Assurance. Analytical Control represents a major and permanent tool for monitoring the finished products. In order to guarantee the Quality of its products, SAFE controls all the diet batches produced and does this at various stages of the process. This monitoring consists, first and foremost, in checking the production information regarding the batch. Each time ingredients are weighed, this is recorded and validated. A direct online check is also made on the physical quality of the product by the operator. A sampling programme makes it possible to collect samples at different stages of the process and at several points. These multiple samples are recorded and kept (in a vacuum seal) by Quality Control for a period of 2 years. SAFE commits itself to a long-term working relationship with its suppliers, mainly French, and this with an aim to preventing or anticipating health and food-safety issues. Nonetheless, the action of controlling ingredients remains a key step in maintaining control over the Quality of the products. Selecting and controlling the ingredients incorporated in the diets constitutes an important factor in managing the quality of the finished products. Monitoring is assured by effecting controls on receipt of the raw materials, which comes down to performing physico-chemical checks as to: the absence of impurities or any foreign bodies, respect for nutritional values: proteins, starch, fats, calcium, phosphor, vitamin values, etc. the level of biological or chemical contaminants present: microbiological analyses, heavy metals, mycotoxins, dioxins, melamines, etc. All this data allows us to establish with certainty the compliance of SAFE products with regulations and with the specific requirements of the animal facilities. This Quality commitment leads to the identification of any possible non compliance. These products are subjected to an organised and specialised type of processing. MASTERING QUALITY This surveillance data on the raw materials allows us to anticipate any non-compliance in the finished products, to continually improve the quality of the ingredients and to set up a strict monitoring process with the suppliers. And this control is completed by our taking an active part in the Food Quality and Safety networks developed by the European Union (such as RASFF Rapid Alert System For Food and Feed) or else by liaising with National bodies. At the end of this Newsletter, you will find examples of recent alerts that might concern the diets for laboratory animals. Added to this monitoring of the ingredients, one should not forget the systematic checks carried out on all the SAFE diets batches. These are performed, in particular, by the QUALITY CONTROL department: Measurements of the granulation of the flours, which is an indicator of a grinding process having been fully mastered and is necessary for there to be constant digestibility of the products. Measurements of the hardness, resistance to abrasion, weights and sizes of the granules, since these parameters allow one to objectively assess the working methods of the granulation process. They also provide information as to how the granules behave during the various stages of being kept in the animal section, as well as at the moment of distributing the granules to the animals. Measurements of the humidity levels and water activity (AW): these criteria allow one to assess the quality of the drying-cooling process. They also contribute to the quality of the finished product during storage and use. This data is all the more important at SAFE since we prohibit the use of preservatives. A systematic chemical control of the products by spectrophotometry. These, then, are the objective indicators of the stability and control exercised over our processes. The constant results obtained are themselves proof of the quality of SAFE products. The latest synthesis in the Nutritional and Contaminants levels shows that all the analyses and products comply with the control programme as it was drawn up, with regulations and with the SAFE norms. They demonstrate the constancy of the nutritional levels and the reduced weight of contaminants. This data brings with it a guarantee of our control of health risks to animals and users alike, who come into contact with the diets. With respect to the nutritional content, the monitoring of protein and fat levels shows a good degree of stability in these nutriments over the course of time. The variations observed are lower than analytical uncertainty and reproducibility. They re of course lower than the variations admitted by regulations and lowoer than the ones promoted by GV-SOLAS. Controlling the sources of the ingredients, the choice of raw materials with low biochemical variations, the design of the formulation and the diversification of the ingredients it is made of, all go to explain these observations. Rigorousness in dosing the ingredients, the process capacity, metrology and the level of tolerance in non-compliance in production also contribute to the low levels of variation in the nutritional values of the finished products. This data illustrates the complying of fixed diet formula concept to the biochemical contraints of raw materials and meet the need for a constantly reliable tool to be deployed in the experimental protocols. The scientific procedures constitute a very considerable investment in both human and technical terms. Acquiring full control over the diets requires regular vigilance and perfect traceability. The source of the ingredients and the implementation of the processes meet these requirements, the analytical information available making it possible to control and to confidently confirm the respect of these requirements. Collaboration with the analytical laboratories is essential in defining the quality of the SAFE finished products. This partnership allows us to innovate in terms of nutritional know-how and in diet quality: it constitutes an essential commitment on our part in order to bring you the best possible guarantees. ANALYTICAL CRITERIA Samples* average* 20 AVERAGE VALUES AND TYPICAL DIVERGENCES Variation Coefficient (%) Analytical Uncertaincy (+/- or %) GV SOLAS limits** EU Regulations Limits*** A03 Proteins % 2 +/- 0.6 [19.5 ;24.5]% [18.81 ;24.19]% A03 Fat 5.15% 0, [4.35 ;6.35]% [4.15 ;7.15]% A03 Potassium 8582ppm % [7295 ;513]ppm [6582 ;12582]ppm A04 Proteins % 2.7 +/-0.6 [14.31 ;18.29]% [14.1 ;18.1]% A04 Fat % 0, [2.26 ;4.26]% [2.06 ;5.06]% A04 Potassium ppm % [5172 ;7672]ppm [4172 ;172]ppm * Sources SAFE **threshold calculated in accordance with GV-SOLAS, Guidelines for the Quality - Assured Production of Laboratory Animal Diets, EN A ***threshold calculated in accordance with RÈGLEMENT (CE) No 767/2009 from EUROPEAN PARLEMENT AND CONSEIL of july 13th in the raw protein in diets A03 and A04 over time. A04 A03 5 The recommendations made by FDA and GV-Solas regarding contaminants provide an initial framework for controlling the chemical and bacteriological risks to do with laboratory animal diets. It does not, however, take into account the identification of new risks. SAFE, which committed itself very early on to Quality in its products, is pursuing this work of assessing food risks. Under this head, we monitor a whole expanded list of pesticides which includes controlling new phytosanitary processes. The same analytical control procedure is also carried out on the list of nitrosamines: their concentrations are close to the thresholds of quantification. The quality of the protein sources and of fish protein especially, goes to explain the complete control exercised over this family of contaminants. In the case of Mycotoxins, monitoring now covers almost 19 molecules. An in-depth study on the subject of Mycotoxins and Phytoestrogens is available on our website at ON A03 AND A04 / REGULATORY REQUIREMENTS, LABORATORY UNCERTAINTIES/ GV-SOLAS REQUIREMENTS Standard deviation* 25 % SAFE s technical service department remains at your disposal for any more information or clarification you may need on these subjects, simply by contacting: info@safe-diets.com REINFORCED CONTROLS ON THE INSTALLATIONS AND A BETTER INTEGRATION OF THE PRINCIPLE OF TRACEABILITY SAFE IS ABLE TO AVAIL ITSELF OF AN ALERT NETWORK FOR CONTROLLING AND PREVENTING RISKS TO THE FOOD SAFETY OF YOUR DIETS The surveillance networks are an essential support and back-up for controlling the Quality of SAFE s finished products. It allows us to transmit information very quickly regarding chemical and bacteriological contaminants linked to the ingredients imported into Europe or else in transit within the European Community. The list given below corresponds to recent alerts that might affect the diets for laboratory animals: SAFE is not affected by any of these. Italy signalled a level of arsenic which was too high (253 ppm) in the manganese oxide coming from India. Germany signalled the presence of metalaxyl (0.4 ppm) and thiamethoxam (2.3 ppm) in Organic sunflower cakes coming from the Netherlands.. Finland and the United Kingdom detected the presence of Chloramphenicol (440 ppb) in enzymatic preparations coming from India and aimed at human consumption. Following the publication of the decree of 27 November 2014 raising the risk level in the highly pathogenic Asian bird flu to moderate over all of Metropolitan France, the Ministry published two safety notices on 4 December 2014 stating the applicable measures to be taken in terms of surveillance and prevention. Since it is not at all present in the farm livestock s or in natural reserves or zoos, SAFE is not affected by this alert. Route de Saint Bris 89290, Augy France T: +33(0) The last stage of the manufacturing process, bagging the diets, requires very special care, focussed on controlling that the product remains intact and the information as to its traceability, which you will have access to. In order to improve these two points even more, we have implemented an investment programme around the twin axes of mechanical and software development. All of the diets storage silos, prior to the bagging stage, have been fitted with control and cleaning hatches in their lower sections. This allows the operators to ensure a complete and perfect emptying of the silos as well as the cleanliness of the installations before they are used again for storing new batches of diets. This new working procedure, performed systematically with each emptying of the silo, is also controlled and safeguarded by the production software system (e.g. data on the cleaning operations). These advances have also made it possible for us to put four new silos into service for storing finished products, whilst ensuring the greatest possible flexibility and protection for the instrument itself and its operation. Parallel to this new installation, the computerisation of the bagging production line has meant, in addition, the automatic transfer of the traceability data for the operating system to the various machines and printers along the production line, thus avoiding the need for different types of information to be entered manually, such as the name of the diet, the shelf life and the batch number. For more informations, please conctat us info@safe-diets.com

3 Which controls and what are the results? SAFE s will and purpose to master Quality in its products requires a considerable control programme and numerous samples taken. In 2013, SAFE analysed more than 35,000 physical, chemical and bacteriological criteria related to these raw materials and finished products. This commitment to Quality amounts to the simple fact that, on average, each batch of SAFE diet is assessed on the basis of more than 145 analytical parameters. This same analytical control is performed in continuous manner and/or at random; it is carried out in partnership with leading laboratories, each in their respective field (nutritional chemistry, nitrate contaminants, etc.) with authorisation issued by COFRAC [The French Certification body]. It should be said that this important analytical programme is completed by: chemical or bacteriological checks to assess the metrological compliance of the production processes, and by tailor-made studies aimed at assessing innovations that might improve the quality of the products, sometimes conducted in partnership with others. THE ANALYSES The reliability of the tools of research is fundamental to the way biomedical and biological studies should be conducted. Stemming from this, mastering control of the living conditions for animals bred for experimentation and their diet constitutes one of the key links in this chain of control. In order to ensure Stability and Quality in the diets distributed to the laboratory animals, SAFE produces diets that implement important procedures to ensure Food Quality and Safety: the training of personnel, the choice of suppliers, hygiene, the standardisation of processes, Quality Control, Quality Assurance. Analytical Control represents a major and permanent tool for monitoring the finished products. In order to guarantee the Quality of its products, SAFE controls all the diet batches produced and does this at various stages of the process. This monitoring consists, first and foremost, in checking the production information regarding the batch. Each time ingredients are weighed, this is recorded and validated. A direct online check is also made on the physical quality of the product by the operator. A sampling programme makes it possible to collect samples at different stages of the process and at several points. These multiple samples are recorded and kept (in a vacuum seal) by Quality Control for a period of 2 years. SAFE commits itself to a long-term working relationship with its suppliers, mainly French, and this with an aim to preventing or anticipating health and food-safety issues. Nonetheless, the action of controlling ingredients remains a key step in maintaining control over the Quality of the products. Selecting and controlling the ingredients incorporated in the diets constitutes an important factor in managing the quality of the finished products. Monitoring is assured by effecting controls on receipt of the raw materials, which comes down to performing physico-chemical checks as to: the absence of impurities or any foreign bodies, respect for nutritional values: proteins, starch, fats, calcium, phosphor, vitamin values, etc. the level of biological or chemical contaminants present: microbiological analyses, heavy metals, mycotoxins, dioxins, melamines, etc. All this data allows us to establish with certainty the compliance of SAFE products with regulations and with the specific requirements of the animal facilities. This Quality commitment leads to the identification of any possible non compliance. These products are subjected to an organised and specialised type of processing. MASTERING QUALITY This surveillance data on the raw materials allows us to anticipate any non-compliance in the finished products, to continually improve the quality of the ingredients and to set up a strict monitoring process with the suppliers. And this control is completed by our taking an active part in the Food Quality and Safety networks developed by the European Union (such as RASFF Rapid Alert System For Food and Feed) or else by liaising with National bodies. At the end of this Newsletter, you will find examples of recent alerts that might concern the diets for laboratory animals. Added to this monitoring of the ingredients, one should not forget the systematic checks carried out on all the SAFE diets batches. These are performed, in particular, by the QUALITY CONTROL department: Measurements of the granulation of the flours, which is an indicator of a grinding process having been fully mastered and is necessary for there to be constant digestibility of the products. Measurements of the hardness, resistance to abrasion, weights and sizes of the granules, since these parameters allow one to objectively assess the working methods of the granulation process. They also provide information as to how the granules behave during the various stages of being kept in the animal section, as well as at the moment of distributing the granules to the animals. Measurements of the humidity levels and water activity (AW): these criteria allow one to assess the quality of the drying-cooling process. They also contribute to the quality of the finished product during storage and use. This data is all the more important at SAFE since we prohibit the use of preservatives. A systematic chemical control of the products by spectrophotometry. These, then, are the objective indicators of the stability and control exercised over our processes. The constant results obtained are themselves proof of the quality of SAFE products. The latest synthesis in the Nutritional and Contaminants levels shows that all the analyses and products comply with the control programme as it was drawn up, with regulations and with the SAFE norms. They demonstrate the constancy of the nutritional levels and the reduced weight of contaminants. This data brings with it a guarantee of our control of health risks to animals and users alike, who come into contact with the diets. With respect to the nutritional content, the monitoring of protein and fat levels shows a good degree of stability in these nutriments over the course of time. The variations observed are lower than analytical uncertainty and reproducibility. They re of course lower than the variations admitted by regulations and lowoer than the ones promoted by GV-SOLAS. Controlling the sources of the ingredients, the choice of raw materials with low biochemical variations, the design of the formulation and the diversification of the ingredients it is made of, all go to explain these observations. Rigorousness in dosing the ingredients, the process capacity, metrology and the level of tolerance in non-compliance in production also contribute to the low levels of variation in the nutritional values of the finished products. This data illustrates the complying of fixed diet formula concept to the biochemical contraints of raw materials and meet the need for a constantly reliable tool to be deployed in the experimental protocols. The scientific procedures constitute a very considerable investment in both human and technical terms. Acquiring full control over the diets requires regular vigilance and perfect traceability. The source of the ingredients and the implementation of the processes meet these requirements, the analytical information available making it possible to control and to confidently confirm the respect of these requirements. Collaboration with the analytical laboratories is essential in defining the quality of the SAFE finished products. This partnership allows us to innovate in terms of nutritional know-how and in diet quality: it constitutes an essential commitment on our part in order to bring you the best possible guarantees. ANALYTICAL CRITERIA Samples* average* 20 AVERAGE VALUES AND TYPICAL DIVERGENCES Variation Coefficient (%) Analytical Uncertaincy (+/- or %) GV SOLAS limits** EU Regulations Limits*** A03 Proteins % 2 +/- 0.6 [19.5 ;24.5]% [18.81 ;24.19]% A03 Fat 5.15% 0, [4.35 ;6.35]% [4.15 ;7.15]% A03 Potassium 8582ppm % [7295 ;513]ppm [6582 ;12582]ppm A04 Proteins % 2.7 +/-0.6 [14.31 ;18.29]% [14.1 ;18.1]% A04 Fat % 0, [2.26 ;4.26]% [2.06 ;5.06]% A04 Potassium ppm % [5172 ;7672]ppm [4172 ;172]ppm * Sources SAFE **threshold calculated in accordance with GV-SOLAS, Guidelines for the Quality - Assured Production of Laboratory Animal Diets, EN A ***threshold calculated in accordance with RÈGLEMENT (CE) No 767/2009 from EUROPEAN PARLEMENT AND CONSEIL of july 13th in the raw protein in diets A03 and A04 over time. A04 A03 5 The recommendations made by FDA and GV-Solas regarding contaminants provide an initial framework for controlling the chemical and bacteriological risks to do with laboratory animal diets. It does not, however, take into account the identification of new risks. SAFE, which committed itself very early on to Quality in its products, is pursuing this work of assessing food risks. Under this head, we monitor a whole expanded list of pesticides which includes controlling new phytosanitary processes. The same analytical control procedure is also carried out on the list of nitrosamines: their concentrations are close to the thresholds of quantification. The quality of the protein sources and of fish protein especially, goes to explain the complete control exercised over this family of contaminants. In the case of Mycotoxins, monitoring now covers almost 19 molecules. An in-depth study on the subject of Mycotoxins and Phytoestrogens is available on our website at ON A03 AND A04 / REGULATORY REQUIREMENTS, LABORATORY UNCERTAINTIES/ GV-SOLAS REQUIREMENTS Standard deviation* 25 % SAFE s technical service department remains at your disposal for any more information or clarification you may need on these subjects, simply by contacting: info@safe-diets.com REINFORCED CONTROLS ON THE INSTALLATIONS AND A BETTER INTEGRATION OF THE PRINCIPLE OF TRACEABILITY SAFE IS ABLE TO AVAIL ITSELF OF AN ALERT NETWORK FOR CONTROLLING AND PREVENTING RISKS TO THE FOOD SAFETY OF YOUR DIETS The surveillance networks are an essential support and back-up for controlling the Quality of SAFE s finished products. It allows us to transmit information very quickly regarding chemical and bacteriological contaminants linked to the ingredients imported into Europe or else in transit within the European Community. The list given below corresponds to recent alerts that might affect the diets for laboratory animals: SAFE is not affected by any of these. Italy signalled a level of arsenic which was too high (253 ppm) in the manganese oxide coming from India. Germany signalled the presence of metalaxyl (0.4 ppm) and thiamethoxam (2.3 ppm) in Organic sunflower cakes coming from the Netherlands.. Finland and the United Kingdom detected the presence of Chloramphenicol (440 ppb) in enzymatic preparations coming from India and aimed at human consumption. Following the publication of the decree of 27 November 2014 raising the risk level in the highly pathogenic Asian bird flu to moderate over all of Metropolitan France, the Ministry published two safety notices on 4 December 2014 stating the applicable measures to be taken in terms of surveillance and prevention. Since it is not at all present in the farm livestock s or in natural reserves or zoos, SAFE is not affected by this alert. Route de Saint Bris 89290, Augy France T: +33(0) The last stage of the manufacturing process, bagging the diets, requires very special care, focussed on controlling that the product remains intact and the information as to its traceability, which you will have access to. In order to improve these two points even more, we have implemented an investment programme around the twin axes of mechanical and software development. All of the diets storage silos, prior to the bagging stage, have been fitted with control and cleaning hatches in their lower sections. This allows the operators to ensure a complete and perfect emptying of the silos as well as the cleanliness of the installations before they are used again for storing new batches of diets. This new working procedure, performed systematically with each emptying of the silo, is also controlled and safeguarded by the production software system (e.g. data on the cleaning operations). These advances have also made it possible for us to put four new silos into service for storing finished products, whilst ensuring the greatest possible flexibility and protection for the instrument itself and its operation. Parallel to this new installation, the computerisation of the bagging production line has meant, in addition, the automatic transfer of the traceability data for the operating system to the various machines and printers along the production line, thus avoiding the need for different types of information to be entered manually, such as the name of the diet, the shelf life and the batch number. For more informations, please conctat us info@safe-diets.com

4 Which controls and what are the results? SAFE s will and purpose to master Quality in its products requires a considerable control programme and numerous samples taken. In 2013, SAFE analysed more than 35,000 physical, chemical and bacteriological criteria related to these raw materials and finished products. This commitment to Quality amounts to the simple fact that, on average, each batch of SAFE diet is assessed on the basis of more than 145 analytical parameters. This same analytical control is performed in continuous manner and/or at random; it is carried out in partnership with leading laboratories, each in their respective field (nutritional chemistry, nitrate contaminants, etc.) with authorisation issued by COFRAC [The French Certification body]. It should be said that this important analytical programme is completed by: chemical or bacteriological checks to assess the metrological compliance of the production processes, and by tailor-made studies aimed at assessing innovations that might improve the quality of the products, sometimes conducted in partnership with others. THE ANALYSES The reliability of the tools of research is fundamental to the way biomedical and biological studies should be conducted. Stemming from this, mastering control of the living conditions for animals bred for experimentation and their diet constitutes one of the key links in this chain of control. In order to ensure Stability and Quality in the diets distributed to the laboratory animals, SAFE produces diets that implement important procedures to ensure Food Quality and Safety: the training of personnel, the choice of suppliers, hygiene, the standardisation of processes, Quality Control, Quality Assurance. Analytical Control represents a major and permanent tool for monitoring the finished products. In order to guarantee the Quality of its products, SAFE controls all the diet batches produced and does this at various stages of the process. This monitoring consists, first and foremost, in checking the production information regarding the batch. Each time ingredients are weighed, this is recorded and validated. A direct online check is also made on the physical quality of the product by the operator. A sampling programme makes it possible to collect samples at different stages of the process and at several points. These multiple samples are recorded and kept (in a vacuum seal) by Quality Control for a period of 2 years. SAFE commits itself to a long-term working relationship with its suppliers, mainly French, and this with an aim to preventing or anticipating health and food-safety issues. Nonetheless, the action of controlling ingredients remains a key step in maintaining control over the Quality of the products. Selecting and controlling the ingredients incorporated in the diets constitutes an important factor in managing the quality of the finished products. Monitoring is assured by effecting controls on receipt of the raw materials, which comes down to performing physico-chemical checks as to: the absence of impurities or any foreign bodies, respect for nutritional values: proteins, starch, fats, calcium, phosphor, vitamin values, etc. the level of biological or chemical contaminants present: microbiological analyses, heavy metals, mycotoxins, dioxins, melamines, etc. All this data allows us to establish with certainty the compliance of SAFE products with regulations and with the specific requirements of the animal facilities. This Quality commitment leads to the identification of any possible non compliance. These products are subjected to an organised and specialised type of processing. MASTERING QUALITY This surveillance data on the raw materials allows us to anticipate any non-compliance in the finished products, to continually improve the quality of the ingredients and to set up a strict monitoring process with the suppliers. And this control is completed by our taking an active part in the Food Quality and Safety networks developed by the European Union (such as RASFF Rapid Alert System For Food and Feed) or else by liaising with National bodies. At the end of this Newsletter, you will find examples of recent alerts that might concern the diets for laboratory animals. Added to this monitoring of the ingredients, one should not forget the systematic checks carried out on all the SAFE diets batches. These are performed, in particular, by the QUALITY CONTROL department: Measurements of the granulation of the flours, which is an indicator of a grinding process having been fully mastered and is necessary for there to be constant digestibility of the products. Measurements of the hardness, resistance to abrasion, weights and sizes of the granules, since these parameters allow one to objectively assess the working methods of the granulation process. They also provide information as to how the granules behave during the various stages of being kept in the animal section, as well as at the moment of distributing the granules to the animals. Measurements of the humidity levels and water activity (AW): these criteria allow one to assess the quality of the drying-cooling process. They also contribute to the quality of the finished product during storage and use. This data is all the more important at SAFE since we prohibit the use of preservatives. A systematic chemical control of the products by spectrophotometry. These, then, are the objective indicators of the stability and control exercised over our processes. The constant results obtained are themselves proof of the quality of SAFE products. The latest synthesis in the Nutritional and Contaminants levels shows that all the analyses and products comply with the control programme as it was drawn up, with regulations and with the SAFE norms. They demonstrate the constancy of the nutritional levels and the reduced weight of contaminants. This data brings with it a guarantee of our control of health risks to animals and users alike, who come into contact with the diets. With respect to the nutritional content, the monitoring of protein and fat levels shows a good degree of stability in these nutriments over the course of time. The variations observed are lower than analytical uncertainty and reproducibility. They re of course lower than the variations admitted by regulations and lowoer than the ones promoted by GV-SOLAS. Controlling the sources of the ingredients, the choice of raw materials with low biochemical variations, the design of the formulation and the diversification of the ingredients it is made of, all go to explain these observations. Rigorousness in dosing the ingredients, the process capacity, metrology and the level of tolerance in non-compliance in production also contribute to the low levels of variation in the nutritional values of the finished products. This data illustrates the complying of fixed diet formula concept to the biochemical contraints of raw materials and meet the need for a constantly reliable tool to be deployed in the experimental protocols. The scientific procedures constitute a very considerable investment in both human and technical terms. Acquiring full control over the diets requires regular vigilance and perfect traceability. The source of the ingredients and the implementation of the processes meet these requirements, the analytical information available making it possible to control and to confidently confirm the respect of these requirements. Collaboration with the analytical laboratories is essential in defining the quality of the SAFE finished products. This partnership allows us to innovate in terms of nutritional know-how and in diet quality: it constitutes an essential commitment on our part in order to bring you the best possible guarantees. ANALYTICAL CRITERIA Samples* average* 20 AVERAGE VALUES AND TYPICAL DIVERGENCES Variation Coefficient (%) Analytical Uncertaincy (+/- or %) GV SOLAS limits** EU Regulations Limits*** A03 Proteins % 2 +/- 0.6 [19.5 ;24.5]% [18.81 ;24.19]% A03 Fat 5.15% 0, [4.35 ;6.35]% [4.15 ;7.15]% A03 Potassium 8582ppm % [7295 ;513]ppm [6582 ;12582]ppm A04 Proteins % 2.7 +/-0.6 [14.31 ;18.29]% [14.1 ;18.1]% A04 Fat % 0, [2.26 ;4.26]% [2.06 ;5.06]% A04 Potassium ppm % [5172 ;7672]ppm [4172 ;172]ppm * Sources SAFE **threshold calculated in accordance with GV-SOLAS, Guidelines for the Quality - Assured Production of Laboratory Animal Diets, EN A ***threshold calculated in accordance with RÈGLEMENT (CE) No 767/2009 from EUROPEAN PARLEMENT AND CONSEIL of july 13th in the raw protein in diets A03 and A04 over time. A04 A03 5 The recommendations made by FDA and GV-Solas regarding contaminants provide an initial framework for controlling the chemical and bacteriological risks to do with laboratory animal diets. It does not, however, take into account the identification of new risks. SAFE, which committed itself very early on to Quality in its products, is pursuing this work of assessing food risks. Under this head, we monitor a whole expanded list of pesticides which includes controlling new phytosanitary processes. The same analytical control procedure is also carried out on the list of nitrosamines: their concentrations are close to the thresholds of quantification. The quality of the protein sources and of fish protein especially, goes to explain the complete control exercised over this family of contaminants. In the case of Mycotoxins, monitoring now covers almost 19 molecules. An in-depth study on the subject of Mycotoxins and Phytoestrogens is available on our website at ON A03 AND A04 / REGULATORY REQUIREMENTS, LABORATORY UNCERTAINTIES/ GV-SOLAS REQUIREMENTS Standard deviation* 25 % SAFE s technical service department remains at your disposal for any more information or clarification you may need on these subjects, simply by contacting: info@safe-diets.com REINFORCED CONTROLS ON THE INSTALLATIONS AND A BETTER INTEGRATION OF THE PRINCIPLE OF TRACEABILITY SAFE IS ABLE TO AVAIL ITSELF OF AN ALERT NETWORK FOR CONTROLLING AND PREVENTING RISKS TO THE FOOD SAFETY OF YOUR DIETS The surveillance networks are an essential support and back-up for controlling the Quality of SAFE s finished products. It allows us to transmit information very quickly regarding chemical and bacteriological contaminants linked to the ingredients imported into Europe or else in transit within the European Community. The list given below corresponds to recent alerts that might affect the diets for laboratory animals: SAFE is not affected by any of these. Italy signalled a level of arsenic which was too high (253 ppm) in the manganese oxide coming from India. Germany signalled the presence of metalaxyl (0.4 ppm) and thiamethoxam (2.3 ppm) in Organic sunflower cakes coming from the Netherlands.. Finland and the United Kingdom detected the presence of Chloramphenicol (440 ppb) in enzymatic preparations coming from India and aimed at human consumption. Following the publication of the decree of 27 November 2014 raising the risk level in the highly pathogenic Asian bird flu to moderate over all of Metropolitan France, the Ministry published two safety notices on 4 December 2014 stating the applicable measures to be taken in terms of surveillance and prevention. Since it is not at all present in the farm livestock s or in natural reserves or zoos, SAFE is not affected by this alert. Route de Saint Bris 89290, Augy France T: +33(0) The last stage of the manufacturing process, bagging the diets, requires very special care, focussed on controlling that the product remains intact and the information as to its traceability, which you will have access to. In order to improve these two points even more, we have implemented an investment programme around the twin axes of mechanical and software development. All of the diets storage silos, prior to the bagging stage, have been fitted with control and cleaning hatches in their lower sections. This allows the operators to ensure a complete and perfect emptying of the silos as well as the cleanliness of the installations before they are used again for storing new batches of diets. This new working procedure, performed systematically with each emptying of the silo, is also controlled and safeguarded by the production software system (e.g. data on the cleaning operations). These advances have also made it possible for us to put four new silos into service for storing finished products, whilst ensuring the greatest possible flexibility and protection for the instrument itself and its operation. Parallel to this new installation, the computerisation of the bagging production line has meant, in addition, the automatic transfer of the traceability data for the operating system to the various machines and printers along the production line, thus avoiding the need for different types of information to be entered manually, such as the name of the diet, the shelf life and the batch number. For more informations, please conctat us info@safe-diets.com

5 Improvements in SAFE beddings The market in beddings became more and more narrow in terms of supply and quality in France over the course of This is down to several things: An ever-greater demand for additional uses and new markets (heating, absorbents for the floor, smoking, etc.), The disappearance of time-honoured players in the field. To ensure quality and a constant supply, for two years now we have been working well-established and exclusive partnership with the leading European manufacturer of beddings for biomedical research laboratories. In order to meet your needs, SAFE takes the time to think about those developments that might bring your work to an optimum level. In the light of your comments, we have decided to improve our range for 2015 by adopting 2 major changes: CHANGE IN THE CONDITIONING OF BEDDINGS IRRADIATED AT 40 KGY These beddings are mostly used for animals kept in isolators. The primary packaging for our beddings in small-scale conditioning will, in the future, be made of edible foodstuff cellulose which will, just as it is at the moment, be vacuum sealed (double pass with the indicator of irradiation) and packed in a cardboard box. PRODUCT LISTING JRS WOOD SHAVINGS Spruce wood shavings of very high quality, even more aerated, with a very low dust ratio, stored in bags of 7 kg to be even easier to stock. This new conditioning will, in particular, allow you to: Perform less handling in the isolator (the primary plastic sleeve won t have to be taken off any more), Use the primary packaging as enrichment if you wish, by bringing it into direct contact with the animals. Three of our products have seen an optimisation in their packaging of more than 33%. This, in itself, makes possible a gain in transportation for everyone involved and a reduction in the environmental impact. Litière Plus BK (D0757P00Z) switching to vacuum-sealed sachets x 400g primary packaging in edible cellulose. Toplit Select Fine-40 (D71P00Z) switching to vacuum-sealed sachets x 400g primary packaging in edible cellulose. Toplit Select Fine-40 (D75P00Z) switching to vacuum-sealed sachets 2*2 kg. ANALYSES OF BEDDING PRODUCTS CARRIED OUT BY INDEPENDENT LABORATORIES These three-monthly microbiological and physico-chemical analyses guarantee for you the absence of any contaminants. They are available by on request: simply address info@safe-diets.com. Allow for a phase-in period for the product to do with stock turnover.

6 AN EVOLUTION IN THE INDUSTRIAL PROCESS SO AS TO ENSURE GREATER RESPECT FOR THE ENVIRONMENT AND FOR WORKING CONDITIONS The whole range of autoclavable diets undergoes a coating process of the granulated feeds with silica (an extremely fine and volatile product) which reduces clumping during the process of autoclaving. Up to now, this operation was performed immediately after the cooling process which, itself, followed the granulation of the products, necessitating a long pneumatic transfer to the bagging process for the feeds (with vertical transportation at a height of 40 metres). This installation has been re-arranged in the final section of the process, just before the sifting stage which comes before the products are put into bags. This is a way to exclude any unwanted dust elements entering in at the early stages of manufacture and thus constituting a safeguard for our whole process. We took the opportunity given by this adaptation to protect the incorporation mechanism with a more precise automated system and to equip the incorporation system in such a way as to give the operators more comfort. All this has been implemented within the framework of our automation programme, to ensure a correct and reproducible working procedure. Real measures of incorporation of SiO2 (Silica) in the products, before and after the evolution of the process, have been effected. Tests on the effectiveness of the processing in the autoclave stage have allowed us to assess how effective this adaptation and the new doses of incorporation are. EFFICIENT VACUUM PACKING OF THE PRODUCTS Vacuum packing the products is still a delicate operation, since it is subject to a number of factors, such as the machine settings, the quality of the films used, the products to be shrink-sealed (bags that differ in terms of quality, unit volume, etc.). By this operation, the product quality has to be guaranteed for you right up to its arrival at your laboratory. With an aim to improve this process even more, numerous test and analytical studies were carried out over the years 2013 and We d like to take this occasion to thank all those of you who allowed us to test certain solutions, even if not all of them then went on to be certified. This work resulted, nonetheless, in many developments which have been implemented this year: Fine tuning of the various temperatures for the moulding of plastics and the sealing of the seams between the films. Controls and settings for calibrating the vacuums during the sealing phases. The implementation of counter-blades to give a more accurate guide for the cutting. The choice of a single supplier for the various types of film. All these different and specific tasks proper to the vacuum-sealing operations have been accompanied by a re-alignment of the setting paper in the packing chests. By adopting a cross-shape setting, we have reduced the risks of vacuum-sealed pockets being chafed during maintenance operations. In the near future, and linked to the visual developments of the chests (our new SAFE logo being incorporated), you will see a special control window appearing in the vacuumsealed products, which will allow you to check on and be assured of the perfect quality level of the products on delivery. NEW PAPER BAGGING FORMAT After more than 12 years of good and loyal services, our bagging section will take on the new developments made in our graphics card. It will undergo just a few stylistic and textual adaptations, without altering its main characteristics (composition, shapes and ergonometrics, food contact approval, dimensions; weight, etc.). We d like to remind you that all our bags are fitted with an easy opening (without scissors or cutters needed) and are made of paper approved for contact with foods. The double bags (controlled and irradiated) are strippable and include traceability info down to the inner bag. You will also see a new logo appearing on the irradiated bags: this is the international logo to identify those products that have been subjected to an ionising process (gamma or electron streaming). For some time already, it is possible to find the batch number written on one of the sides of the bag, next to the diet name. This will allow you to make an added visual identification of the products. FLASH NEWS SAFE DIETS ASIA SAFE is developing its business in ASIA. A second participation in AFLAS 2014 (Kuala Lumpur - Malaysia) as exhibitor and the success of this trade fair has strengthened our resolve in this project. CUSTOM DIETS SATISFACTION SURVEY In order to provide an ever better service, we have to get to know you better, too. It is for this end that we carried out a customer satisfaction survey in our Custom Diets and I want especially to thank those among you who took part in this. The survey allowed us to get a clearer idea of expectations in what is our growth sector. Over the course of 2015, we shall be implementing a number of procedures aimed at giving us more profile in this field and enabling us to exchange ideas and impressions with the diets users. REGULATORY EVOLUTION In terms of additive, the European Union imposes a regular review of the effectiveness of nutritional ingredients. In that framework, Inositol improperly classified as vitamin, but not biologically recognized as such by nutritionists, has been the subject of a review of its biological interest. In 2014, EFSA assessments have not identified any technical efficiency and interest provided that ingredient in synthetic form. Accordingly, carbocyclic compound, naturally in plants (particularly in cereals under phytate) is no longer allowed to be added as an additive in feeds. The European Regulation 1249/2014 limits its use in fish feeds. Feed for other animals are not allowed to receive Inositol and its synthetic derivatives as of June In compliance with European regulations, in accordance with the SAFE transparency commitments, we inform you that from 1st June 2015, production of SAFE diets will not incorporate this feed additive. This involves: autoclavable rodent diets, guinea pig and primate diets. They will be marketed as of July Sources EFSA : European Food and Safety Agency.