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The role of science in Codex standards.

The key principle in the development of Codex standards is to ensure that the decision-making process is based on sound science. The approval for the use of food additives and other chemicals in foods should be made only when adequate scientific data is available. The same principle applies to the development of maximum tolerable (or residue) levels for contaminants in foods. Using the General Standards for Contaminants and Toxins in Foods as an example, the following criteria are considered, when developing recommendations and standards: Toxicological information; Analytical data; Intake data; Fair trade considerations; Technological considerations; and Risk assessment and risk management considerations. The Codex Alimentarius Commission has repeatedly emphasized the use of risk analysis approach, in particular the use of risk assessment in conducting the safety evaluation of food additives agricultural and veterinary chemicals and environmental and industrial contaminants in foods. In this respect, the well known efforts of the FAO/WHO Joint Expert Committee on Food Additives (JECFA) and the FAD/WHO Joint Meeting on Pesticide Residues (JMPR) provide the much needed information and recommendations for the risk assessment of specific chemicals. The risk assessment approach is also used in the safety evaluation of foods derived from modern biotechnology as well as in the quantitative assessment of microbiological risks in foods.

Agriculture↗

[The "Alphabetical Dioscorides" (a propos the Codex Vindobonensis Med. gr. 1)].

The Greek "Alphabetical Dioscorides" of the Codex Vindobonensis (Viennese Codex) is above all a bibliographic work, remarkably illustrated, intended to show gratitude to an eminent person. It comprises exclusively currently-available plants which might be used by people of a cultivated milieu, who, not having studied medicine, would like to cure relatively benign illnesses while limiting any recourse to exotic drugs. On the contrary, the Latin Alphabaeticals from the eleventh century and the centuries following, as well as the Greek Alphabeticals of the Renaissance, cover all the drugs in the Materia medica and respond to the desire to quickly find the pharmacologic properties of medicinal herbs introduced into prescriptions which might be formulated by physicians.

Austria↗

The Chilander Medical Codex: its importance for the medieval Serbian pharmacy.

Early Serbian writings on pharmacotherapy such as those of medieval collections were based on Greek and Roman sources. With the discovery of the Chilandar Medical Codex, relevant information on Serbian medieval pharmacy and medicine were gathered. According to the Chilander Medical Codex, drugs were prepared using the most sophisticated techniques and the latest knowledge of that time.

History of Pharmacy↗

[The Austrian penal code and the Codex Ur-nammu--a comparison from the forensic medicine viewpoint].

A comparison between the Mesopotamian Law (Codex Ur-nammu) and the Austrian Penal Code reveals the long-sightedness of the founder of the 3rd dynasty from Ur, called Ur-nammu. It seems extremely remarkable that at those remote times (3rd Millenium B. C.) body injuries were satisfied by simple money-penalties. The Codex Ur-nammu therefore not only represents on exceedingly piece of work from the historical point of view but also from the point of view from Legal Medicine.

Austria↗

Nutrition and the work of the Codex Alimentarius Commission.

Nutritional and dietary aspects are central to the work of the Codex Alimentarius Commission on foods special dietary uses and on nutrition labelling, and are playing a major part in the development of standards such as those for cereals and vegetable proteins. In the general work of the Commission and its subsidiary bodies many draft and existing standards either contain specific nutritional provisions or individually or collectively help to protect the nutritional quality of the food supply by controlling the composition and description of foods passing in trade. Work now in courses and planning by the Commission will increase the commitment to nutrition in the Codex programme.

Dietary Services↗

[Codex foodstuffs committee FAO/WHO on methods of analysis and sampling].

The topics of the XIX Session of the Codex Alimentarius Committee held in Budapest are reviewed. In the report on the Session the main stress was laid on the matters connected with guidelines on sampling, endorsement of methods of analysis for codex standards and the matters concerning quality assurance systems in laboratories.

Chemistry Techniques, Analytical↗

[Activity of the Codex Alimentarius Commission FAO/WHO on quality assurance in the laboratory].

The activity of the Codex Alimentarius Commission FAO/WHO concerning the quality assurance in laboratory was discussed. Major documents issued by the joint efforts of the international organizations (IUPAC, ISO, AOAC Int.) and Codex Alimentarius FAO/WHO Committee on Methods of Analysis and Sampling (CCMAS) are also presented in the article. The basic task of the CCMAS is reviewing and harmonization of the international documents in order to make them available for food analytical laboratories and to recommend the internationally recognised approaches for: collaborative studies--Protocol for Design, Conduct and Interpretation of Method-performance Studies. Pure & Appl. Chem. 1995, vol. 67, 332-343 proficiency testing--The International Harmonized Protocol for the Proficiency Testing (Chemical) Analytical Laboratories. Pure & Appl. Chem. 1993, Vol. 65, 2123-2144 and J.AOAC Int. 1993, Vol. 76, 926-940 internal quality control (IQC)--Harmonized Guidelines for Internal Quality Control in the Analytical Chemistry Laboratories. Pure & Appl. Chem. 1995, Vol. 67, 650-666 determining and use of recovery factor--Harmonized Protocol for Recovery Factor in Analytical Measurements--document CX/MAS 97/6 applicability of the measurement uncertainty--Measurement Uncertainity--document CX/MAS 97/7.

Chemistry Techniques, Analytical↗

Acute intake assessment: evolution within the Codex Committee on Pesticide Residues. WHO Joint Secretary of the Joint FAO/WHO meeting on pesticide residues JMPR.

The Codex Committee on Pesticide Residues (CCPR), in its development of international standards, has been considering during the last few years the implications of residues of acutely toxic pesticides in food commodities. CCPR has asked its scientific advisory body, the Joint FAO/WHO Meeting on Pesticide Residues (JMPR), for advice on the safety of the standards that are being developed. This work began in 1993. The 1994 JMPR first decided to use the 'acute reference dose' as a toxicological benchmark for a 'short-term ADI'. A number of acute reference doses have been allocated at subsequent meetings. The 1998 JMPR decided to consider the allocation of an acute reference dose whenever a full evaluation of a pesticide is undertaken. General guidance for the allocation of an acute reference dose was provided by the 1998 JMPR, which is discussed in this paper.

Animals↗

Risk analysis and the law: international law, the World Trade Organization, Codex Alimentarius and national legislation.

This paper discusses the place of risk analysis in international trade from a US perspective, through looking at the activities of the World Trade Organization and the Codex Alimentarius Commission. After examining what the trade agreements say about risk analysis and how international bodies are advancing and using risk analysis, the paper goes on to assess how risk analysis is used at a national level. Finally, recommendations are made for strengthening international food safety initiatives.

Biotechnology↗

[Birth representation with reference to the magical coriander prescription of Codex Vindobonensis 93, fol. 102r, of the Austrian National Library].

One of the most impressive manuscript illustrations of the medieval history of midwifery is found in the Codex Vindobonensis 93, fol. 102r (a manuscript from the early 13th century), illustrating a magic prescription of herba coriandrum to accelerate childbirth. The composition of the omnibus manuscript is critically delineated in its historical context. The illustration, being isolated without any obstetrical teaching text, is judged as part of the ancient tradition of teaching by images which has no parallel north of the Alps. The different image traditions are reflected in the historical use and illustration of the midwifery chair, which can be traced back only to the beginning of the 16th century in Central Europe and on the British Isles. The importance of the magic prescription is shown by comparison within the same and other collections used in the Middle Ages and classified in the context of further traditions of magic in midwifery.

Europe↗

Allermatch, a webtool for the prediction of potential allergenicity according to current FAO/WHO Codex alimentarius guidelines.

BACKGROUND: Novel proteins entering the food chain, for example by genetic modification of plants, have to be tested for allergenicity. Allermatch http://allermatch.org is a webtool for the efficient and standardized prediction of potential allergenicity of proteins and peptides according to the current recommendations of the FAO/WHO Expert Consultation, as outlined in the Codex alimentarius. DESCRIPTION: A query amino acid sequence is compared with all known allergenic proteins retrieved from the protein databases using a sliding window approach. This identifies stretches of 80 amino acids with more than 35% similarity or small identical stretches of at least six amino acids. The outcome of the analysis is presented in a concise format. The predictive performance of the FAO/WHO criteria is evaluated by screening sets of allergens and non-allergens against the Allermatch databases. Besides correct predictions, both methods are shown to generate false positive and false negative hits and the outcomes should therefore be combined with other methods of allergenicity assessment, as advised by the FAO/WHO. CONCLUSIONS: Allermatch provides an accessible, efficient, and useful webtool for analysis of potential allergenicity of proteins introduced in genetically modified food prior to market release that complies with current FAO/WHO guidelines.

Allergens↗

Codex Alimentarius: food quality and safety standards for international trade.

Since 1962, the Codex Alimentarius Commission (CAC) of the Food and Agriculture Organisation/World Health Organisation has been responsible for developing standards, guidelines and other recommendations on the quality and safety of food to protect the health of consumers and to ensure fair practices in food trade. The mission of the CAC remains relevant, but a number of factors have shown the need for new techniques to form the basis of food standards, the most important of which is risk analysis. The authors give a brief description of the role and work of the CAC and the efforts deployed by the Commission to respond to the challenges posed by new approaches to government regulation, harmonisation of national requirements based on international standards and the role of civil society.

Commerce↗

Pharmacopoeia as quality codex for the manufacturers.

Three are the basic features of a medicine legally introduced on the market: efficacy, safety and quality. With regarding to drugs listed in a national or international pharmacopoeia, the ratio between efficacy and safety, within the range of dosage established by the codex, must be considered as official by the industry. As far as quality is concerned, the pharmacopoeia plays a fundamental role in establishing methods of analysis and technical control intended as official reference in case of controversy. The quality of drugs, pharmaceutical adjuvants or preparations listed in a modern pharmacopoeia must be considered by the industry as the minimum level of the acceptable standard for medical use, to ensure efficacy under proper storage conditions. In fact, the specifications are largely based upon suggestions made by manufacturers. Pharmaceutical specialties, being registered by Health Authorities following suitable documentation, do not have to be subjected to the standards established by the pharmacopoeia for new drugs or formulation adjuvants. The constant effort of the manufacturers to minimize risks leads to optimum quality levels, considering that samples used for control by the Health Authorities are usually picked from commercial packages containing a small number of units. To ensure statistical compliance of every sample with official pharmacopoeial standards, manufacturers are forced to exercise the highest care in every process of production and packaging. There cannot possibly be a guarantee that every single unit at the consumer's disposal will actually comply with the quality level established by a modern pharmacopoeia. Optimum quality level in every package of medical products can be achieved by following the "Good Manufacturing Practice" sponsored by the WHO; this goal requires skilled people and sophisticated equipment. The practice of quality control as an essential part of the manufacturing process in a wide range of pharmaceuticals, provides an excellent experience that may be useful to the pharmacopoeial commissions. Therefore a closer co-operation between health officials and industry's experts must be considered the best way to improve the specifications, to speed-up the revision of monographs and to collect reports on stability tests. The part of a modern pharmacopoeia, devoted to tests and standards appears today as the most important for the pharmaceutical industry because, when a controversy arises about drugs, the official methods established by the pharmacopoeia play a fundamental role in the enforcement of law. The task of compiling each new edition of a modern pharmacopoeia is becoming increasingly difficult; to speed revision any time a problem arises, the revision committees may seek advice from the numerous experts of the pharmaceutical industry thus achieving a most profitable collaboration.

International Cooperation↗

Galeno's De Pulsis et Urinis from the Casinensis Codex 97.

Between the end of the 9th and the first decade of the 10th century, two medical codes were produced in the Cassino area: The Pluteo 73.41 manuscript of the Laurenziana library in Florence and the Casinensis Codex 97 kept in the archives of the abbey. They are written in Beneventano-Cassinese language and are enriched with drawings of plants and animals. They were most certainly used for the teaching and learning of medicine. On pages 26-31, there is Galeno's De Pulsis et Urinis, that is presented in the form of "Epistola", containing 30 chapters in which the characteristics and variations of pulse, fever and urine are described in different illnesses, thus influencing the prognosis. Galeno's manuscript De Pulsis et Urinis, as well as his other manuscripts contained in Code 97, have an important role in emphasizing the writings of one of the greatest and prolific doctors of ancient times who laid the basis for medicine in the East and in the West. The source is most likely Sergio's which belong to the medical school of Costantinople (his death is known to be in 536); he translated all of Galeno's known writings in the 6th century.

Fever↗

[The activity of Codex Alimentarius Commission FAO/WHO Committee on Methods of Analysis and Sampling].

In the light of issues discussed during 24th Session of Codex Committee on Methods of Analysis and Sampling that was held in Budapest, 18-22 November 2002, the current activity of this Committee is presented. More detailed information about some of the most advanced or interesting documents is included, i. e. Proposed Draft General Guidelines On Sampling, Harmonized IUPAC Guidelines for Single-Laboratory Validation of Methods of Analysis, Consideration of methods for the detection and identification of food derived from biotechnology.

Congresses as Topic↗

Assuring food safety: the complementary tasks and standards of the World Organisation for Animal Health and the Codex Alimentarius Commission.

The Agreement on the Application of Sanitary and Phytosanitary Measures of the World Trade Organization specifically recognises the international standards developed by the World Organisation for Animal Health (OIE) and the Codex Alimentarius Commission (CAC). OIE standards focus on animal health and zoonoses and those of the CAC on food safety, but since zoonoses can affect food safety, it is vital that the two organisations cooperate closely to avoid duplication of effort, gaps and conflicting standards. The OIE has established an Animal Production Food Safety Working Group to promote cooperation with the CAC and to act as a steering committee for the OIE's work programme on the development of standards aimed at protecting consumers from foodborne hazards arising from animals at the production level of the food chain. This paper describes briefly how standards are developed by the OIE and the CAC and gives examples of how the tasks and standards of the two organisations complement each other in helping to assure food safety. The areas covered include meat hygiene, the identification and traceability of live animals, model certificates for international trade, antimicrobial resistance, veterinary drugs, animal feed, and salmonellosis.

Animal Welfare↗

[The German addendum to Hildegard von Bingen's 'Liber simplicis medicinae' in Codex 6952 of the Bibliothèque Nationale in Paris (fol. 232v-238v)].

The article contains an analysis and edition of the German appendix to Hildegard of Bingen's 'Liber simplicis medicinae' ('LSM', also known as 'Physica') in Codex 6952 of the Bibliothèque Nationale in Paris. Surprisingly, the German text is not based on the preceding Latin treatise, but on another unknown version of the 'LSM' which is closer to the archetype. The appendix thus has to be regarded as a new manuscript find, which also contains material found only in Hildegard's 'Liber compositae medicinae' ('LCM', also known as 'Causae et Curae'). This suggests that the translator had access to both texts, or that both once circulated as one treatise. In the reception of Hildegard's work, the 13-page German appendix is unique in that Hildegard's description of nature is transformed into three different types of medical writing: 1) a herbal, 2) a catalogue of diseases from head to toe and their remedies, and 3) a dietetic list of foodstuffs. To illustrate the technique applied by the compiler/translator, the edition of the Paris-appendix identifies all the quotes from the 'LSM' and 'LCM' which have so far been uncovered.

Germany↗