Consumer Products And The Environment Research Articles

Food for thought — Paving the way for a UK roadmap towards optimum consumer safety: Development, Endorsement and Regulatory acceptance of New Approach Methodologies (NAMs) in Chemical Risk Assessment and Beyond

Advances in biosciences, chemistry, technology, and computer sciences have resulted in the unparalleled development of candidate New Approach Methodologies over the last few years. Many of these are potentially invaluable in the safety assessment of chemicals, but very few have been adopted for regulatory decision making. There is an immediate opportunity to use NAMs in safety assessment where the vision is to be able to predict risk more rapidly, accurately, and efficiently to further assure consumer safety.In order to achieve this, the UK Food Standards Agency (FSA) and the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) have developed a roadmap towards acceptance and integration of these new approach methodologies into safety and risk assessments for regulatory decision making. The roadmap provides a UK blueprint for the transition of NAMs from the research laboratory to their use in regulatory decision making. This will require close collaboration across disciplines (chemists, toxicologists, informaticians, risk assessors and others), and across chemical sectors, to develop, verify and utilise appropriate models. Linking up internationally, and harmonization will be fundamental.

Safety Assessment on Product E 401 (Sodium Alginate) Used as a Surface Treatment in Entire Fruits and Vegetables (RP290)

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in February 2021 from Bio Natural Solutions – BNS S.A.C. (‘the Applicant’) for the modification of the conditions of use of sodium alginate (CAS: 9005-38-3), which is an already authorised food additive (E 401), to the surface of entire fresh fruit and vegetables, as a coating to preserve them. The Applicant intends to extend the use of the sodium alginate (E 401) as a coating material within the food category: 4.1.1 ‘Entire fresh fruit and vegetables to include citrus fruit, melons, pineapples, bananas, papayas, mangoes, avocados, pomegranates’ at the level of quantum satis. To support the FSA and FSS in evaluating the dossier the Joint Expert Group on Additives, Enzymes and other regulated products (AEJEG) were asked to review the dossier and the supplementary information from the Applicant. The AEJEG concluded that no risk to health would be presented from this extension of use of E 401 on the basis that the additive was considered of low toxicological concern, as indicated by the European Food Standards Agency’s (EFSA) decision that a numerical ADI was not required. The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) also reviewed the AEJEG safety assessment agreeing with the conclusions of the AEJEG. The views of the AEJEG and COT have been taken into account in this safety assessment which represents the opinion of the FSA and FSS on the extension of use of the sodium alginate (E 401) as a coating material in entire fresh fruit and vegetables.

Safety Assessment RP1190 2-Hydroxyethyl Methacrylate Phosphate

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in January 2021 by Keller and Heckman LLP for the authorisation of 2-hydroxyethyl methacrylate phosphate (HEMAP) as a monomer in a commercial product for use in the manufacture of kitchen countertops and sinks that are intended for contact with all types of food. All components of the commercial product are listed in assimilated Regulation EU No 10/2011 on plastic materials and articles intended to come into contact with food. The application and the following assessment are for HEMAP only, not the commercial product. Satisfactory information regarding the identity of substance, physical and chemical properties, intended application of substance, data on migration of substance and toxicological data were submitted. To support the FSA and FSS in evaluating the dossier, the Joint Expert Group on Food Contact Materials (FCMJEG) were asked to review the dossier submitted by the Applicant and the subsequent additional information requested. The FCMJEG concluded that the there was no concern to human safety from the use of HEMAP in the commercial product to be used in the manufacture of kitchen countertops and sinks. The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) also reviewed the FCMJEG safety assessment agreeing with the conclusions of the FCMJEG. The views of the FCMJEG and COT have been taken into account in this safety assessment which represents the opinion of the FSA and FSS on the authorisation of HEMAP as a monomer for use in the manufacture of kitchen countertops and sinks.

Safety Assessment RP1466 2-Hydroxy-4-methoxybenzaldehyde

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in February 2022 from Firmenich S.A. (Meyrin, Switzerland) for the approval of use of 2-hydroxy-4-methoxybenzaldehyde as a flavouring substance in or on food (Application reference: RP1466). This Application is being considered within the food flavourings regime. The Applicant intends to use the Candidate Substance as a flavouring ingredient in accordance with Article 4 of assimilated Regulation (EC) No 1334/200. The Candidate Substance (2-hydroxy-4-methoxybenzaldehyde; CAS 673-22- 3) is a pale yellow to orange–pink solid powder that imparts an odour/flavour with a vanilla bean almond-like note at ambient conditions. To support the FSA and FSS in undertaking this safety assessment the Additives, Enzymes and other regulated products Joint Expert Group (AEJEG) were asked to provide their risk assessment advice and conclusions on the information provided within the dossier and the supplementary information from the applicant. The AEJEG concluded that 2-hydroxy-4-methoxybenzaldehyde is safe under the proposed conditions of use. The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) also reviewed the AEJEG safety assessment agreeing with the conclusions of the AEJEG. The views of the AEJEG and COT have been taken into account in this safety assessment which represents the conclusions of the FSA and FSS on the Candidate Substance (2-hydroxy-4-methoxybenzaldehyde) as a flavouring ingredient.

Risk Assessment of "Other Substances" – L- tryptophan

Risk Assessment of "Other Substances" – L- tryptophan

UK Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) Symposium: Potential implications of obesity on persistent organic pollutant kinetics and possible ramifications for risk assessment

UK Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) Symposium: Potential implications of obesity on persistent organic pollutant kinetics and possible ramifications for risk assessment

Exposure to phthalic acid, phthalate diesters and phthalate monoesters from foodstuffs: UK total diet study results

Phthalates are ubiquitous in the environment and thus exposure to these compounds can occur in various forms. Foods are one source of such exposure. There are only a limited number of studies that describe the levels of phthalates (diesters, monoesters and phthalic acid) in foods and assess the exposure from this source. In this study the levels of selected phthalate diesters, phthalate monoesters and phthalic acid in total diet study (TDS) samples are determined and the resulting exposure estimated. The methodology for the determination of phthalic acid and nine phthalate monoesters (mono-isopropyl phthalate, mono-n-butyl phthalate, mono-isobutyl phthalate, mono-benzyl phthalate, mono-cyclohexyl phthalate, mono-n-pentyl phthalate, mono-(2-ethylhexyl) phthalate, mono-n-octyl phthalate and mono-isononyl phthalate) in foods is described. In this method phthalate monoesters and phthalic acid are extracted from the foodstuffs with a mixture of acidified acetonitrile and dichloromethane. The method uses isotope-labelled phthalic acid and phthalate monoester internal standards and is appropriate for quantitative determination in the concentration range of 5–100 µg kg–1. The method was validated in-house and its broad applicability demonstrated by the analysis of high-fat, high-carbohydrate and high-protein foodstuffs as well as combinations of all three major food constituents. The methodology used for 15 major phthalate diesters has been reported elsewhere. Phthalic acid was the most prevalent phthalate, being detected in 17 food groups. The highest concentration measured was di-(2-ethylhexyl) phthalate in fish (789 µg kg–1). Low levels of mono-n-butyl phthalate and mono-(2-ethylhexyl) phthalate were detected in several of the TDS animal-based food groups and the highest concentrations measured corresponded with the most abundant diesters (di-n-butyl phthalate and di-(2-ethylhexyl) phthalate). The UK Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) considered the levels found and concluded that they did not indicate a risk to human health from dietary exposure alone.

Dietary exposure to metals and other elements in the 2006 UK Total Diet Study and some trends over the last 30 years

Concentrations of 24 elements including metals in the 2006 UK Total Diet Study (TDS) were measured and dietary exposures estimated. Composite samples for the 20 TDS food groups (bread, fish, fruit, etc.) were collected from 24 UK towns and analysed for their levels of aluminium, antimony, arsenic, barium, bismuth, cadmium, chromium, copper, germanium, indium, lead, manganese, mercury, molybdenum, nickel, palladium, platinum, rhodium, ruthenium, selenium, strontium, thallium, tin, and zinc. Concentrations of each of the elements in the food groups were lower than or similar to those reported in the previous TDS survey, conducted in 2000, with the exception of aluminium, barium, and manganese. Dietary exposures to the 24 elements were estimated for UK consumers and compared with previous estimates made over the last 30 years in order to examine any trends in exposure to these elements in the typical UK diet. Population exposures to the elements have generally declined over time, and exposures to most of these elements remain at low levels. The independent UK Government scientific Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) commented on the estimated dietary exposures, taking into account their previous evaluations (in 2003 and 2008), and identified no major concerns for the health of consumers, but did advise that there was a need for more information on aluminium and barium, and also commented that dietary exposure to inorganic arsenic and to lead should continue to be reduced.

Determination of brominated flame retardants in food by LC–MS/MS: diastereoisomer-specific hexabromocyclododecane and tetrabromobisphenol A

The levels of the brominated flame retardants (BFRs) hexabromocyclododecane (α, β and γHBCD diastereoisomers) and tetrabromobisphenol A (TBBPA) have been determined in two studies using LC–MS/MS. The methodology developed was validated in-house and used to analyse UK 2004 Total Diet Study (TDS) samples and shellfish (oysters, mussels and scallops) collected from Scotland. HBCD was detected in most samples; in both studies the αHBCD diastereoisomer was generally the most abundant as opposed to the γ diastereoisomer that tends to dominate in environmental samples and manufactured products. It is reported that selective metabolism or biotransformation of the β and γ diastereoisomers may be taking place. TBBPA was not detected in any samples above the limit of detection, which was as low as 0.05 µg kg–1. This may be because TBBPA, unlike HBCD, is chemically bound to the polymer matrix during manufacture and not readily leached. The UK Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) concluded that the concentrations of HBCD and TBBPA detected in the TDS study did not raise toxicological concerns and, as levels in the shellfish samples were in a similar concentration range, it was concluded that exposure to the BFRs measured is not significant when compared to exposure from the rest of the diet.

Risk assessment of dietary exposure to methylmercury in fish in the UK

Risk assessment of chemicals in food is generally based upon the results of toxicological studies in laboratory animals, allowing for uncertainties relating to interspecies differences, human variability, and gaps in the database. Use of quantitative human data is preferable if available, as in the example of methylmercury. Methylmercury is a neurotoxic environmental contaminant, for which fish is the main source of dietary exposure. Human data from poisoning incidents and epidemiological studies have been used by expert committees to derive a guideline intake level for methylmercury, based on the susceptibility of the most sensitive lifestage, the developing fetus. In the UK, an expert group of nutritionists and toxicologists was formed to review the benefits and risks associated with fish consumption. A formal risk-benefit analysis was not possible because the nutritional data were not sufficiently quantitative. The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT), therefore, modified the risk assessment approach to derive different guideline intake levels for different subgroups of the population. The COT opinion was used to provide targeted advice on how much fish can be consumed without undue risk from the contaminants. Consumption by adults of one weekly portion (140 g) of shark, swordfish or marlin, would lead to an exceedance of the guideline intake for methylmercury of 40-90%, set to protect the developing fetus, without considering intake from the rest of the diet. Pregnant women and women who may become pregnant within 1 year were, therefore, advised to avoid consumption of these species. Intakes in other adults would be within a higher guideline intake, set to protect groups of the population other than the developing fetus. However, consumption by children of one weekly portion of these species could lead to an exceedance of this guideline intake by up to 60%, without considering intake from the rest of the diet. It was, therefore, advised that consumption of these species by children should be avoided.

The UK Food Standards Agency Draft Report on Variability and Uncertainty in Toxicology: A Response by FRAME

At the request of the Food Standards Agency, the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) established a Working Group on Variation and Uncertainty in Toxicology (WG VUT). In April 2006, the WG VUT produced a draft report for public consultation. FRAME made a submission in response to this consultation in July 2006. We commend the WG VUT for its comprehensive account of many of the problems associated with risk assessment, and for making recommendations about the problems that need to be addressed. We were particularly encouraged by the WG VUTs recognition of the need for guidelines on how toxicological studies should be conducted and data analysed. However, we believe that the report has not achieved all of its objectives. It does not adequately consider how modern technologies, experimental design, statistical analysis and species extrapolation can be used in practice to address variability and uncertainty. There is a disproportionate focus on the sources of variability and uncertainty in human data, with relatively little consideration of how variation and uncertainty due to animal tests can be addressed. Furthermore, it is clear that, until the advantages and limitations of all toxicological methods are fully appraised and testing strategies and guidelines are agreed, the scope for improving the existing approaches to risk assessment will be severely limited. Hence, the use of alternative methods for hazard identification and characterisation merit more consideration than they were given in the draft report.

Dioxins and polychlorinated biphenyls (PCBs) in fish oil dietary supplements: Occurrence and human exposure in the UK

Commercially available fish oil supplements sourced from retail outlets in the UK, as well as by mail order, were surveyed in 2000–02 for dioxin (PCDD/Fs) and polychlorinated biphenyl (PCB) content. Sampled products were representative of market share. The WHO-TEQ values for these products ranged from 0.18 to 8.4 ng kg−1 for ΣPCDD/F and from 1.1 to 41 ng kg−1 for Σ dioxin-like PCBs. The results suggest a downward trend in the levels of dioxins in fish oil supplements over the last decade, since levels for similar products ranged from 0.3 to 10 ng kg−1 for ΣPCDD/F WHO-TEQ in 1996. Levels of ICES (International Council for the Exploration of the Seas) 7 PCBs in the current study ranged from 8.3 to 267 µg kg−1. Subsequent to this survey, European Union legislation has been introduced that includes a maximum limit of 2 ng kg−1 WHO-TEQ for dioxins in fish oil products for human consumption. Twelve of the 33 products reported here would have exceeded this limit. Negotiations are in progress to incorporate dioxin-like PCBs into the European Union regulations. When manufacturer-recommended doses were applied to the observed levels, the estimated upper bound human exposure to dioxins and dioxin-like PCBs from dietary intake of these products ranged from 0.02 to 7.1 pg WHO-TEQ kg−1 body weight day−1 for adults and from 0.02 to 10 pg WHO-TEQ kg−1 body weight day−1 for schoolchildren. This level rises to 1.8–8.9 pg WHO-TEQ kg−1 body weight day−1 for adults and 1.4–14 pg WHO-TEQ kg−1 body weight day−1 for schoolchildren when combined with the average exposure from the whole diet in 1997. Again, subsequent to this survey, the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) revised the UK tolerable daily intake (TDI) for mixtures of dioxins and dioxin-like PCBs from 10 to 2 pg WHO-TEQ kg−1 body weight day−1. This is in line with the tolerable weekly intake (TWI) of 14 pg WHO-TEQ kg−1 body weight set by the Scientific Committee on Food (SCF).

Committee on Toxicity draft report on phyto‐oestrogens and health – review of proposed health effects of phyto‐oestrogen exposure and recommendations for future research

SummaryThe public health implications of exposure to phyto‐oestrogens in the diet was recently reviewed by the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) for the Food Standards Agency and provided the agency with recommendations for future research. These recommendations suggest a broadening of interest to the other classes of phyto‐oestrogens, such as the lignans and prenylated compounds which to date have not been as thoroughly investigated as the isoflavones class. COT's draft report suggests that future research may focus on further understanding how these compounds work, defining the relative importance of metabolism, the hypothetical risk:benefit in subsections of the population who may be exposed to high levels through the diet or through supplement intake and the relative importance of phyto‐oestrogens in relation to chronic diseases such as osteoporosis and cancer. However, it will be important to integrate future programmes with ongoing European Union and international funded work to ensure effective use of resources to further our understanding of the relative risk:benefit of these compounds to human health.

Report of a symposium on the use of genomics and proteomics in toxicology.

Over the past few years, and especially since publication of the sequence of the human genome (International Human Genome Sequencing Consortium, 2001), there has been increasing pressure to incorporate novel technologies such as proteomics and genomics into toxicological risk assessment. The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) and its sister Committees on Carcinogenicity and Mutagenicity (COC and COM) held a symposium to consider this issue on 8 October 2001 at Skipton House, Elephant and Castle, London, UK. The meeting was attended by members of COT, COC and COM and also included members of the Advisory Committee on Hazardous Substances, the Advisory Committee on Pesticides, invited speakers from academia and industry and delegates from various Government Departments. It was also open to anyone with an interest in this area. COT, COC and COM are independent expert advisory committees appointed by the Chief Medical Officer and the Chairman of the Board of the Food Standards Agency. The Committees advise on all aspects related to the toxicity, carcinogenicity and mutagenicity of chemicals. They also have a general remit to advise on important general principles or new scientific discoveries in connection with safety assessment of chemicals. This symposium brought together experts in the fields of genomics and proteomics to assist the committees in providing advice to Government Departments and Regulatory Agencies on the use of these technologies in risk assessment. The symposium started with a general overview of these subjects and introduced the areas of discussion for individual Working Groups. The concluding session included a report from each Working Group and overall recommendations.

Soya and health 2002 – clinical evidence, dietetic applications

Soya and health 2002 – clinical evidence, dietetic applications

Guidelines for the safety assessment of microbial enzymes used in food.

The regulatory approach in the UK to the safety assessment of microbial enzymes has been reviewed. The Committee on the Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) devised, in December 1992, a strategy based on toxicological testing of a representative batch of the final purified fermentation product and achieving a high standard of quality control through the development and maintenance of quality assurance specifications.

Criteria for setting quantitative estimates of acceptable intakes of chemicals in food in the U.K.

The U.K. Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) provides advice to government on the safety-in-use of additives and on the possible health hazards from contaminants in food. In the past the COT has given advice on additives in descriptive rather than numerical terms; chemicals were either acceptable, temporarily acceptable or not acceptable for food use. From 1989 onwards the Committee will set acceptable intakes for new additives or existing additives under review and tolerable intakes for contaminants. These will provide guidance on levels of intake which generally should not be exceeded, and will be an aid to decisions on maximum levels of use of particular additives in specified foods. The criteria used by the COT to set quantitative estimates of acceptable and tolerable intakes are discussed.