Alain-Claude Roudot

Consumption of cosmetic products by the French population. First part: Frequency data

The aim of this study was to assess the percentage of users, the frequency of use and the number of cosmetic products consumed at home by the French population. The evaluation was performed for adult, child and baby consumers. Pregnant women were also taken into account in this work. All in all, 141 products cosmetics including general hygiene, skin care, hair care, hair styling, make-up, fragrances, solar, shaving and depilatory products were studied. The strengths of the study were the separation of data by sex and by age groups, the consideration of a priori at risk subpopulations and the consideration of a large number of cosmetic products. These current consumption data could be useful for safety assessors and for safety agencies in order to protect the general population and these at risk subpopulations.

A Preliminary Risk Assessment of Human Exposure to Phycotoxins in Shellfish: A Review

ABSTRACT Over the past few decades, phycotoxins, secondary metabolites produced by toxic phytoplankton, have seen an increase in their frequency, concentrations, and geographic distribution. As shellfish accumulate phycotoxins making them unfit for human consumption, they are considered as an important food safety issue. Thus, a consumer exposure assessment on phycotoxins is necessary. Exposure assessment requires two types of information: contamination and consumption data. Shellfish contamination data on major toxins encountered by at-risk populations (Domoic Acid group, Okadaic Acid group, and Saxitoxin group) have been reviewed. Consumption data have been reviewed for both general and potential high-consumer populations. Then, we undertook acute and chronic exposure assessments, combining available French contamination data and our own consumption data. Studies including exposure assessment were then reviewed. Lastly, risk characterization was undertaken. It can be concluded that both acute and chronic exposure to phycotoxins via shellfish consumption is a matter of concern, mainly for high consumers identified in this review (specific populations and shellfish harvesters). However, the results for risk characterization must be improved. There is a need for (i) toxicological data to establish a Tolerable Daily Intake; (ii) an assessment of consumption and contamination data, undertaken at the same time, so as to assess exposure.

Prenatal developmental toxicity studies on di-n-heptyl and di-n-octyl phthalates in Sprague-Dawley rats

This study evaluates the developmental toxicity of two dialkyl phthalate esters, di-n-heptyl phthalate (DHPP) and di-n-octyl (DnOP) phthalate, which have straight-alkyl side chains of seven and eight carbons, respectively. Sprague-Dawley rats were administered 0, 0.25, 0.50, or 1g/kg/day of DHPP or DnOP, by gavage, on gestation days 6-20. DHPP and DnOP had no adverse effect on maternal feed consumption and body weight gain, or on the incidence of post-implantation loss and fetal body weight. There was no increase in the incidence of fetal malformations or external and visceral variations, whatever treatment. A significant increase in rudimentary lumbar ribs was observed at all doses of DHPP and DnOP. The anogenital distance of the male fetuses was significantly decreased at the highest dose of DHPP. This parameter was not affected by DnOP. Thus, the lowest-observed-adverse-effect level (LOAEL) for developmental toxicity was 0.25 g/kg/day for DHPP and DnOP.

Probabilistic mercury multimedia exposure assessment in small children and risk assessment

OBJECTIVES Emissions of mercury in the environment have been decreasing for several years. However, mercury species are still found in different media (food, water, air and breast-milk). Due to mercury toxicity and typical behaviour in children, we have conducted a mercury exposure assessment in French babies, and small children aged 0 to 36months. METHOD Consumption and mercury concentration data were chosen for the exposure assessment. The Monte Carlo technique has been used to calculate the weekly exposure dose in order to integrate inter-individual variability and parameter uncertainty. Exposure values have been compared to toxicological reference values for health risk assessment. RESULTS Inorganic mercury median exposure levels ranged from 0.160 to 1.649μg/kg of body weight per week (95th percentile (P95): 0.298-2.027µg/kg bw/week); elemental mercury median exposure level in children was 0.11ng/kg bw/week (P95: 28ng/kg bw/week); and methylmercury median exposure level ranged from 0.247 to 0.273µg/kg bw/week (P95: 0.425-0.463µg/kg bw/week). Only elemental mercury by inhalation route (indoor air) and methylmercury by ingestion (fish and breast-milk) seem to lead to a health risk in small children. CONCLUSIONS These results confirm the importance of assessing total mercury concentration in media like breast-milk, indoor air and dust and methylmercury level in food, other than fish and seafood. In this way, informed monitoring plan and risk assessment in an at-risk sub-population can be set.

Assessment of dietary exposure to bisphenol A in the French population with a special focus on risk characterisation for pregnant French women

Bisphenol A (BPA) is used in a wide variety of products and objects for consumers use (digital media such as CDs and DVDs, sport equipment, food and beverage containers, medical equipment). Here, we demonstrate the ubiquitous presence of this contaminant in foods with a background level of contamination of less than 5 μg/kg in 85% of the 1498 analysed samples. High levels of contamination (up to 400 μg/kg) were found in some foods of animal origin. We used a probabilistic approach to calculate dietary exposure from French individual consumption data for infants under 36 months, children and adolescents from 3 to 17 years, adults over 18 years and pregnant women. The estimated average dietary exposure ranged from 0.12 to 0.14 μg/kg body weight per day (bw/d) for infants, from 0.05 to 0.06 μg/kg bw/d for children and adolescents, from 0.038 to 0.040 μg/kg bw/d for adults and from 0.05 to 0.06 μg/kg bw/d for pregnant women. The main sources of exposure were canned foods (50% of the total exposure), products of animal origin (20%) and 30% as a background level. Based on the toxicological values set by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) for pregnant women, the risk was non negligible. Thus, we simulated scenarios to study the influence of cans and/or food of animal origin on the BPA-related risk for this specific population.

Risks for human health related to the presence of pyrrolizidine alkaloids in honey, tea, herbal infusions and food supplements

Abstract EFSA was asked by the European Commission to deliver a scientific opinion on the risks for human health related to the presence of pyrrolizidine alkaloids (PAs) in honey, tea, herbal infusions and food supplements and to identify the PAs of relevance in the aforementioned food commodities and in other feed and food. PAs are a large group of toxins produced by different plant species. In 2011, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) assessed the risks related to the presence of PAs in food and feed. Based on occurrence data limited to honey, the CONTAM Panel concluded that there was a possible health concern for those toddlers and children who are high consumers of honey. A new exposure assessment including new occurrence data was published by EFSA in 2016 and was used to update the risk characterisation. The CONTAM Panel established a new Reference Point of 237 μg/kg body weight per day to assess the carcinogenic risks of PAs, and concluded that there is a possible concern for human health related to the exposure to PAs, in particular for frequent and high consumers of tea and herbal infusions. The Panel noted that consumption of food supplements based on PA‐producing plants could result in exposure levels too close (i.e. less than 100 times lower) to the range of doses known to cause severe acute/short term toxicity. From the analysis of the available occurrence data, the CONTAM Panel identified a list of 17 PAs of relevance for monitoring in food and feed. The Panel recommended continuing the efforts to monitor the presence of PAs in food and feed, including the development of more sensitive and specific analytical methods. A recommendation was also issued on the generation of data to identify the toxic and carcinogenic potency of the PAs commonly found in food.

Risks for public health related to the presence of tetrodotoxin (TTX) and TTX analogues in marine bivalves and gastropods

Abstract Tetrodotoxin (TTX) and its analogues are produced by marine bacteria and have been detected in marine bivalves and gastropods from European waters. The European Commission asked EFSA for a scientific opinion on the risks to public health related to the presence of TTX and TTX analogues in marine bivalves and gastropods. The Panel on Contaminants in the Food Chain reviewed the available literature but did not find support for the minimum lethal dose for humans of 2 mg, mentioned in various reviews. Some human case reports describe serious effects at a dose of 0.2 mg, corresponding to 4 μg/kg body weight (bw). However, the uncertainties on the actual exposure in the studies preclude their use for derivation of an acute reference dose (ARfD). Instead, a group ARfD of 0.25 μg/kg bw, applying to TTX and its analogues, was derived based on a TTX dose of 25 μg/kg bw at which no apathy was observed in an acute oral study with mice, applying a standard uncertainty factor of 100. Estimated relative potencies for analogues are lower than that of TTX but are associated with a high degree of uncertainty. Based on the occurrence data submitted to EFSA and reported consumption days only, average and P95 exposures of 0.00–0.09 and 0.00–0.03 μg/kg bw, respectively, were calculated. Using a large portion size of 400 g bivalves and P95 occurrence levels of TTX, with exception of oysters, the exposure was below the group ARfD in all consumer groups. A concentration below 44 μg TTX equivalents/kg shellfish meat, based on a large portion size of 400 g, was considered not to result in adverse effects in humans. Liquid chromatography with tandem mass spectroscopy (LC–MS/MS) methods are the most suitable for identification and quantification of TTX and its analogues, with LOQs between 1 and 25 μg/kg.

Probabilistic assessment of exposure to nail cosmetics in French consumers.

The aim of this study was to assess probabilistic exposure to nail cosmetics in French consumers. The exposure assessment was performed with base coat, polish, top coat and remover. This work was done for adult and child consumers. Dermal, inhalation and oral routes were taken into account for varnishes. Exposure evaluation was performed for the inhalation route with polish remover. The main route of exposure to varnishes was the ungual route. Inhalation was the secondary route of exposure, followed by dermal and oral routes. Polish contributed most to exposure, regardless of the route of exposure. For this nail product, P50 and P95 values by ungual route were respectively equal to 1.74 mg(kg bw week)(-1) and 8.55 mg(kg bw week)(-1) for women aged 18-34 years. Exposure to polish by inhalation route was equal to 0.70 mg(kg bw week)(-1) (P50) and 5.27 mg(kg bw week)(-1) (P95). P50 and P95 values by inhalation route were respectively equal to 0.08 mg(kg bw week)(-1) and 1.14 mg(kg bw week)(-1) for consumers aged 18-34 years exposed to polish remover. This work provided current exposure data for nail cosmetics, and a basis for future toxicological studies of the uptake of substances contained in nail cosmetics in order to assess systemic exposure.

Exposure method development for risk assessment to cosmetic products using a standard composition

In a risk assessment of cosmetic products, it is necessary to know both qualitative and quantitative compositions. Currently, European Regulation No. 1223/2009 requires the industries to provide ingredient lists for finished cosmetic products but not their concentrations. Ingredient concentrations are available in few bibliographic references but in an incomplete and approximate way. In this study, we propose a method to qualitatively and quantitatively estimate the composition of a cosmetic product. This method has the advantages of being applicable to all cosmetic products and supplying concentration data for all ingredients. The results obtained seem quite fair compared to literature data. Applied to nail polish as an example, this method can be used to assess exposure per ingredient according to the Monte Carlo probabilistic method. It should be promising to assess the consumer risk to cosmetic product compositions.

Adverse effects of diisooctyl phthalate on the male rat reproductive development following prenatal exposure.

In a first study, rats were given diisooctyl phthalate (DIOP, CAS 27554-26-3) at 0, 0.1, 0.5, and 1g/kg/day, by gavage, on gestation days 6-20 (GD). There was a significant increase in resorptions at 1g/kg/day and a reduction in fetal weights at 0.5 and 1g/kg/day. Malpositioned testes were observed in fetuses at 1g/kg/day, and supernumerary lumbar ribs and ossification delay at 0.5 and 1g/kg/day. In a follow-up study, DIOP administered on GD 12-19 reduced fetal testicular testosterone at 0.1g/kg/day and above. Finally, postnatal reproductive assessment was conducted in adult male offspring prenatally exposed to DIOP on GD 12-21. Abnormalities of reproductive system (e.g. hypospadias, non scrotal testes, and hypospermatogenesis) were observed in a few adult males at 0.5g/kg/day, and with a high incidence at 1g/kg/day. Thus, DIOP displayed an antiandrogenic activity and disrupted the male reproductive development.