Nicotine and tobacco products contain characterizing flavours that mask their harshness, ease their use and increase their acceptability. Recent estimates indicate that flavour use is common, and thousands of flavours are now available for electronic nicotine delivery systems. Non-traditional flavours, like fruit and confectionery, are particularly appealing to young people, and use of these flavours is also increasing among adults, especially among adult smokers who are trying to quit smoking. Flavours in all nicotine and tobacco products have been shown not only to increase the appeal and first use of the products but may also contribute to extent of use, progression from experimental to regular use and dependence. Another concern is that chemicals in flavours may contribute to the toxicity of these products. Flavours are not regulated uniformly in nicotine and tobacco products or among countries. Some countries ban all flavours in all products, others have bans on only some flavours (e.g. excluding menthol), while others include only certain products (e.g. traditional products, such as cigarettes and smokeless tobacco) in regulations. This report on flavours in nicotine and tobacco products calls for adoption of common terminology for flavours in nicotine and tobacco products and consideration of policy for reducing the availability of flavoured nicotine and tobacco products on the market to those for which there is clear evidence of benefit in assisting smokers in quitting use of traditional smoked tobacco products.

This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of various food additives, including flavouring agents, with a view to concluding as to safety concerns and to preparing specifications for identity and purity. The first part of the report contains a general discussion of the principles governing the toxicological evaluation of and assessment of dietary exposure to food additives, including flavouring agents. A summary follows of the Committee’s evaluations of technical, toxicological and dietary exposure data for 10 food additives (Allura Red AC; carob bean gum; lutein esters from Tagetes erecta; octenyl succinic acid (OSA)– modified gum arabic; pectin; Quinoline Yellow; rosemary extract; steviol glycosides; tartrazine; and xanthan gum) and five groups of flavouring agents (alicyclic, alicyclic-fused and aromatic-fused ring lactones; aliphatic and aromatic amines and amides; aliphatic secondary alcohols, ketones and related esters; cinnamyl alcohol and related substances; and tetrahydrofuran and furanone derivatives). Specifications for the following food additives were revised: aspartame; cassia gum; citric and fatty acid esters of glycerol (CITREM); modified starches; octanoic acid; starch sodium octenyl succinate; and total colouring matters. Annexed to the report are tables summarizing the Committee’s recommendations for dietary exposures to and toxicological evaluations of all of the food additives, including flavouring agents, considered at this meeting.

This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of various contaminants or groups of contaminants in food. The first part of the report contains a brief description of general considerations addressed at the meeting, including updates on matters of interest to the work of the Committee. A summary follows of the Committee’s evaluations of technical, toxicological and/or dietary exposure data for six contaminants or groups of contaminants (aflatoxins, 4,15-diacetoxyscirpenol, fumonisins, glycidyl esters, 3-MCPD esters and 3-MCPD, sterigmatocystin) as well as an evaluation of co-exposure of fumonisins with aflatoxins. Annexed to the report is a summary of the toxicological and dietary exposure information as well as the Committee’s recommendations on the contaminants and groups of contaminants considered at this meeting.

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Good pharmacopoeial practices; FIP-WHO technical guidelines: points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products; Guidance on good manufacturing practices for biological products; Guidance on good manufacturing practices: inspection report, including Appendix 1: Model inspection report; Guidance on good data and record management practices; Good trade and distribution practices for starting materials; Guidelines on the conduct of surveys of the quality of medicines; Collaborative procedure between the World Health Organization (WHO) prequalification team and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines; Guidance for organizations performing in vivo bioequivalence studies; and World Health Organization (WHO) general guidance on variations to multisource pharmaceutical products.

This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of various food additives and contaminants and to prepare specifications for identity and purity. The first part of the report contains a brief description of general considerations addressed at the meeting, including updates on matters of interest to the work of the Committee. A summary follows of the Committee's evaluations of technical, toxicological and/or dietary exposure data for seven food additives (benzoates; lipase from Fusarium heterosporum expressed in Ogataea polymorpha; magnesium stearate; maltotetraohydrolase from Pseudomonas stutzeri expressed in Bacillus licheniformis; mixed β-glucanase, cellulase and xylanase from Rasamsonia emersonii; mixed β-glucanase and xylanase from Disporotrichum dimorphosporum; polyvinyl alcohol (PVA)- polyethylene glycol (PEG) graft copolymer) and two groups of contaminants (non-dioxin-like polychlorinated biphenyls and pyrrolizidine alkaloids). Specifications for the following food additives were revised or withdrawn: advantame; annatto extracts (solavnt extracted bixin, ad solvent-extracted norbixin); food additives containing aluminium and/or silicon (aluminium silicate; calcium aluminium silicate; calcium silicate; silicon dioxide, amorphous; sodium aluminium silicate); and glycerol ester of gum rosin. Annexed to the report are tables or text summarizing the toxicological and dietary exposure information and information on specifications as well as the Committees recommendations on the food additives and contaminants considered at this meeting.

This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of residues of certain veterinary drugs in food and to recommend maximum levels for such residues in food. The first part of the report considers general principles regarding the evaluation of residues of veterinary drugs within the terms of reference of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), including MRLs for generic fish species, acute reference doses (ARfDs) for veterinary drugs, an approach for dietary exposure assessment of compounds used for multiple purposes (i.e veterinary drugs and pesticides), dietary exposure assessment for less-than-lifetime exposure, and the assessment of short-term (90-day and 12-month) studies in dogs. Summaries follow of the Committee's evaluations of toxicological and residue data on a variety of veterinary drugs: two insecticides (diflubenzuron and teflubenzuron), an antiparasitic agent (ivermectin), an ectoparasiticide (sisapronil) and a β2-adrenoceptor agonist (zilpaterol hydrochloride). In addition, the Committee considered issues raised in concern forms from the Codex Committee on Residues of Veterinary Drugs in Foods on lasalocid sodium, an antiparasitic agent. Annexed to the report is a summary of the Committee's recommendations on these drugs, including acceptable daily intakes (ADIs), ARfDs and proposed MRLs.

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances, and the establishment of international biological reference materials. Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development and adoption of new and revised WHO Recommendations, Guidelines and guidance documents. Following these discussions, a WHO guidance document on Regulatory assessment of approved rDNA-derived biotherapeutics was adopted along with WHO Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions and on WHO good manufacturing practices for biological products. In addition, revised WHO Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines were also adopted by the Committee. Subsequent sections of the report provide information on the current status and proposed development of international reference materials in the areas of antibiotics; biotherapeutics other than blood products; blood products and related substances; in vitro diagnostic device reagents; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1). The above four WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2–5). Finally, all additions and discontinuations made during the 2015 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 6. The updated full catalogue of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.

The WHO Expert Committee on Drug Dependence (ECDD) is responsible for assessing psychoactive substances for possible control under the international drug control conventions. The ECDD reviews the therapeutic usefulness, the liability for abuse and dependence, and the public health and social harm potential of each substance under review. After the ECDD advises the Director-General of WHO as to whether to schedule or to amend the scheduling status of a substance, the Director-General will, as appropriate, communicate the recommendations to the United Nations Secretary-General. The Secretary-General communicates the advice to the Commission on Narcotic Drugs (CND), as appropriate. This report presents the recommendations of the thirty-seventh meeting of the WHO Expert Committee on Drug Dependence. The report summarizes the review of nine substances and the ECDD’s recommendations for the scheduling of seven substances. The report also provides updates on ketamine and cannabis, as requested byresolutions of the Commission on Narcotic Drugs. It contains updates on the work of international bodies concerned with controlled substances, as well as summaries of the follow-up discussions on recommendations made at the previous ECDD meeting, and on the discussions on criteria for assessing new psychoactive substances and on terminology.

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances, and the establishment of international biological reference materials. Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development and adoption of new and revised WHO Recommendations, Guidelines and guidance documents. Following these discussions, a WHO guidance document on the Scientific principles for regulatory risk evaluation on finding an adventitious agent in a marketed vaccine was adopted along with WHO Guidelines on procedures and data requirements for changes to approved vaccines and revised WHO Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated). Subsequent sections of the report provide information on the current status and proposed development of international reference materials in the areas of antibiotics; biotherapeutics other than blood products; blood products and related substances; in vitro diagnostic device reagents; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1) followed by the above three WHO documents adopted on the advice of the Committee (Annexes 2-4). All additions and discontinuations made during the 2014 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 5. The updated full catalogue of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.

This report presents the conclusions reached and recommendations made by the members of the WHO Study Group on Tobacco Product Regulation (TobReg) at its seventh meeting, in December 2013, during which it reviewed background papers specially commissioned for the meeting, which dealt, respectively, with the following four themes: Novel tobacco products, including potential reduced exposure products Smokeless tobacco products: research needs and regulatory recommendations Reduced ignition propensity cigarettes: research needs and regulatory recommendations Non-exhaustive priority list of toxic contents and emissions of tobacco products. The Study Group's recommendations in relation to each theme are set out at the end of the section dealing with that theme; its overall recommendations are summarized in Chapter 6.

This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of various food additives, including flavouring agents, and to prepare specifications for identity and purity. The first part of the report contains a general discussion of the principles governing the toxicological evaluation of and assessment of dietary exposure to food additives, including flavouring agents. A summary follows of the Committee's evaluations of technical, toxicological and dietary exposure data for eight food additives (Benzoe tonkinensis; carrageenan; citric and fatty acid esters of glycerol; gardenia yellow; lutein esters from Tagetes erecta; octenyl succinic acid-modified gum arabic; octenyl succinic acid-modified starch; paprika extract; and pectin) and eight groups of flavouring agents (aliphatic and alicyclic hydrocarbons; aliphatic and aromatic ethers; ionones and structurally related substances; miscellaneous nitrogen-containing substances; monocyclic and bicyclic secondary alcohols, ketones and related esters; phenol and phenol derivatives; phenyl-substituted aliphatic alcohols and related aldehydes and esters; and sulfur-containing heterocyclic compounds). Specifications for the following food additives were revised: citric acid; gellan gum; polyoxyethylene (20) sorbitan monostearate; potassium aluminium silicate; and Quillaia extract (Type 2). Annexed to the report are tables summarizing the Committee's recommendations for dietary exposures to and toxicological evaluations of all of the food additives and flavouring agents considered at this meeting.

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Revised procedure for the development of monographs and other texts for The International Pharmacopoeia; Revised updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia; Revision of the supplementary guidelines on good manufacturing practices: validation, Appendix 7: non-sterile process validation; General guidance for inspectors on hold-time studies; 16 technical supplements to Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products; Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients; Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability: revision; Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products: revision; and Good review practices: guidelines for national and regional regulatory authorities.

This report presents the recommendations of the thirty-sixth WHO Expert Committee on Drug Dependence (ECDD). The ECDD is responsible for the assessment of therapeutic usefulness, the liability to abuse and dependence and the public health and social harm of each substance under review. After receiving the advice from the Expert Committee to schedule or to amend the scheduling status of a substance, the Director-General of WHO will as appropriate, communicate the recommendations to the United Nations. The report summarizes the review of 26 substances and the Committee's recommendations for scheduling under the international drug control conventions. The report also contains updates from international bodies concerned with controlled substances, a summary of the follow-up on recommendations made at the previous Committee meeting and a summary of the discussion on improving data collection and evidence for prioritization and substance evaluation, in particular for new psychoactive substances. Issues identified for consideration at future Expert Committee meetings are also listed.