Unknown author(Rijksinstituut voor Volksgezondheid en Milieu RIVM, 2011-12-02)
June 15, 2011, the Foundation "An Animal A Friend" (EDEV) sent a letter to the House of Commons to argue against postponement of the EU trade ban on cosmetics (ingredients) tested on animals. This trade ban is due March 2013, but in Europe there is a growing body of opinion to postpone the trade ban. The Foundation EDEV argues that postponing the trade ban is unnecessary because sufficient alternatives to animal testing exist. This notion is based on the report "Meeting the deadline of the 2013 EU Marketing Ban - A Scientific Review of Non-Animal Tests for Cosmetics" of the "British Union for the Abolition of Vivisection" (BUAV). This report indicates that for all toxicological endpoints for which no trade ban exists, suitable non-animal methods for determining the safety of cosmetics are available. This view clearly differs from that of a large number of experts that, upon invitation by the European Commission, have explored per toxicological endpoint the opportunities for non-animal methods for safety testing of cosmetics. They concluded that the development of non-animal methods for these endpoints needs at least 5-10 years (DG SANCO report). The present report discusses for each for of the above-mentioned endpoints if and how the tests proposed in the BUAV report can be used to determine the safety of cosmetics. Over the past decades, much progress has been made internationally in developing non-animal alternative tests for determining the safety of cosmetics. The acceptance and implementation of these tests in international guidelines for regulatory quantitative risk assessment is much less advanced. The current situation gives some cause for optimism, but it's still too early to implement guidelines based on the existing alternatives. Over the next 5-10 years significant progress is expected in this area. The DG SANCO report provides a realistic representation of the current situation. The RIVM therefore disagrees with the conclusions of the BUAV report that for the above-mentioned endpoints non-animal methods are available for determining the safety of cosmetics.
Salverda-Nijhof JGW; Kooi M; de Wit-Bos L; Bourgeois FC; van Gorcum TF; Colijn J; van Engelen J; Donker G(Rijksinstituut voor Volksgezondheid en Milieu RIVM, 2011-06-17)
Over 1,250 reports of adverse effects after the use of cosmetic products. Since the start of the CESES (Consumer Exposure Skin Effects and Surveillance) project, more than 1,250 reports of adverse reactions to cosmetic products have been received via the website www.cosmeticaklachten.nl and from participating family doctors and dermatologists. The most commonly reported adverse effects are erythema and itching, predominantly those localized around the eye(lids) and on the face. The most frequently mentioned product categories are skin care products, hair care products and make-up. In particular, there have been many reports of day- and night creams, shampoo and eye make-up (mascara, eyeliner, eye pencil and eye make-up remover) causing an adverse effect. A relatively high number of complaints about sun care products have also been received. Women reported 80-90% of the adverse effects. Of the consumers who reported an adverse effect on the website, 37% had visited a family doctor and 13% had consulted a dermatologist. Only 17% of the consumers had returned to the store where they had bought the product, and only 10% had contacted the manufacturer. Worthy of note is that only 30% of the respondents were familiar with the shelf life symbol or the note is that only 30% of the respondents were familiar with the shelf life symbol or the period of time after opening that the cosmetic product may be used without any harm to the consumer. Hardly any adverse effects were reported for babies and young children. There were also very few reports of adverse effects associated with perfumes, which is remarkable because fragrance allergens are considered to be the most important allergenic substances present in consumer products. Based on the severity of reports received to date via the website, RIVM has on three different occasions sent an alert to the nVWA (Food and Consumer Product Safety Authority) concerning a specific cosmetic product. After contacting the manufacturer, the nVWA has concluded that these cosmetic products do not pose a risk to the consumer.
Buchner F; van Egmond H; Ocke M(Rijksinstituut voor Volksgezondheid en Milieu RIVM, 2011-09-05)
Execution of food consumption surveys (FCS) and duplicate diet studies (DDS) can complement each other. If calculations from FCS detect an exceeding of the norm, DDS can verify whether this is a realistic picture of the potential risks. In this letter report we compare two different methods for the estimation of nutrient and contaminate intake from foods. One method uses the consumption data from FCS, executed in representative sample of Dutch population groups. This consumption data is coupled to concentration data. The other method uses 24 hour duplicate diets in relatively small research populations. In these duplicate diets the concentration of different nutrients and contaminants can be measured. For some nutrients the results of FCS and DDS were comparable. However, for several other nutrients inconsistent results were observed. Estimated intake was either higher or lower for one method compared to the other; and this differed by age group and gender. For children we also had data for several contaminants. Intake of three of the four contaminants from DFC data was (much) higher compared to the intakes measured in DDS. This confirmed the assessment that concentration data for several mycotoxins were based on expected high values and not on a random sample.
Tijhuis MJ; Wapperom D; Wolterink G; van Oosterhout CHM; Temme EHM; van Klaveren J; Verhagen H; Fransen HP(Rijksinstituut voor Volksgezondheid en Milieu RIVM, 2011-12-31)
Market introduction of products sweetened with steviol glycosides (extracts from the Stevia plant), as recently authorized by the European Committee, is not likely to create a serious health problem in the Netherlands. However, extreme consumers of products sweetened with steviol glycosides may exceed the acceptable daily intake (ADI). The potential future exposure of children in the Netherlands to steviol glycosides is explored by means of scenarios. These comprised observational intake data from the DNFCS-young children (aged 2 to 6 years), the EC list of food products that are authorized to contain steviol glycosides and the maximum permitted levels for these products. Besides a worst case scenario, a 10% market share scenario was calculated. In this scenario, dietary exposure to steviol glycosides in children aged 2 to 6 years was 1.7 mg/kg bodyweight per day at the 95th percentile (expressed as steviol equivalents) and the ADI (4 mg/kg bodyweight per day) was exceeded by 0.3% of the children. The most important contributors to exposure to steviol glycosides in children were water-based flavoured drinks. From a literature study on health effects it was concluded that little data exist on interactive effects of sweeteners, but from what is available interactive adverse effects are not expected. It is advised to monitor exposure to all sweeteners, so that potential problems in the future can be foreseen and acted upon.
ter Burg W; Jongeneel WP(Rijksinstituut voor Volksgezondheid en Milieu RIVM, 2011-12-28)
Three exemplary substances are identified to evaluate risks of systemic effects after occupational dermal exposure to chemical substances. Legislation requires that employers provide a safe and healthy workplace for their employees and moreover that employers should be able to prove that the occupational exposure is safe. However, up till now an evaluation of risks associated with occupational dermal exposure is rarely included. Through literature research and consultation of experts several substances are identified. These substances can be readily absorbed through the skin and could cause adverse health effect in the body after absorption. For three substances the use, the hazard and the absorption through the skin are described.
Smit CE; Bodar CWM; te Biesebeek JD; Wolterink G(Rijksinstituut voor Volksgezondheid en Milieu RIVM, 2011-07-13)
RIVM has evaluated the risks for humans resulting from the presence of imidacloprid in surface water. Imidacloprid is an insecticide that has been detected in surface water in levels exceeding the current Dutch water quality standards. People may be exposed to imidacloprid by drinking water that is abstracted from surface water, by consumption of fish which may have taken up the compound, or by swimming. The risk resulting from each of these exposure routes is evaluated using the Acceptable Daily Intake (ADI). The ADI is the amount that may be taken up on a daily basis without causing negative effects on human health. Considering the observed concentrations in surface water there is no risk for humans. This assessment is limited to imidacloprid, other compounds that might be present at the same time are not taken into consideration. Potential risks to the ecosystem are also outside the scope of this evaluation.
de Bruijn ACP; de Vries C(Rijksinstituut voor Volksgezondheid en Milieu RIVM, 2011-05-19)
In many hospitals, the purchasing department has a role, if not a key role in the handling of recalls. This fits the image of the purchasing department as sentinel for medical devices, such as the Health Care Inspectorate described in their report 'State of Healthcare 2008'. It is recommended that the handling of recalls is further strengthened through the purchasing department.It is recommended that the handling of recalls is further strengthened through the purchasing department. The results of the study provide indications for improvements with regard to the contact person in the hospital, the communication between supplier and hospital, the internal communication in the hospital and the procedures. The quality of the recall procedures varies widely. Many practical issues are addressed, but there are often important aspects which remain underexposed. In a minority of hospitals there is a single contact person for recalls. In most hospitals, there are contact persons for subgroups of medical devices, but it is not clear whether the suppliers know of these contact persons. medical devices hospitals recall coordinator
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