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Harrogate, United Kingdom

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Harrogate, United Kingdom
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Elsmore R.,JSC International Ltd | Urbanowska M.,ReachCentrum SA
Chimica Oggi/Chemistry Today | Year: 2017

Europe remains one of the most highly regulated regions in the world with ever stricter and more complex legislation. This article looks at the REACH Regulation and its impact on business within the EU including considerations for mergers, acquisitions and restructuring within organisations.


Pilling E.,JSC International Ltd | Campbell P.,Syngenta | Coulson M.,Syngenta | Ruddle N.,Syngenta | Tornier I.,Eurofins
PLoS ONE | Year: 2013

Neonicotinoid residues in nectar and pollen from crop plants have been implicated as one of the potential factors causing the declines of honey bee populations. Median residues of thiamethoxam in pollen collected from honey bees after foraging on flowering seed treated maize were found to be between 1 and 7 μg/kg, median residues of the metabolite CGA322704 (clothianidin) in the pollen were between 1 and 4 μg/kg. In oilseed rape, median residues of thiamethoxam found in pollen collected from bees were between <1 and 3.5 μg/kg and in nectar from foraging bees were between 0.65 and 2.4 μg/kg. Median residues of CGA322704 in pollen and nectar in the oilseed rape trials were all below the limit of quantification (1 μg/kg). Residues in the hive were even lower in both the maize and oilseed rape trials, being at or below the level of detection of 1 μg/kg for bee bread in the hive and at or below the level of detection of 0.5 μg/kg for hive nectar, honey and royal jelly samples. The long-term risk to honey bee colonies in the field was also investigated, including the sensitive overwintering stage, from four years consecutive single treatment crop exposures to flowering maize and oilseed rape grown from thiamethoxam treated seeds at rates recommended for insect control. Throughout the study, mortality, foraging behavior, colony strength, colony weight, brood development and food storage levels were similar between treatment and control colonies. Detailed examination of brood development throughout the year demonstrated that colonies exposed to the treated crop were able to successfully overwinter and had a similar health status to the control colonies in the following spring. We conclude that these data demonstrate there is a low risk to honey bees from systemic residues in nectar and pollen following the use of thiamethoxam as a seed treatment on oilseed rape and maize. © 2013 Pilling et al.


The nitro-substituted neonicotinoid insecticides, which include imidacloprid, thiamethoxam and clothianidin, are widely used to control a range of important agricultural pests both by foliar applications and also as seed dressings and by soil application. Since they exhibit systemic properties, exposure of bees may occur as a result of residues present in the nectar and/or pollen of seed- or soil-treated crop plants and so they have been the subject of much debate about whether they cause adverse effects in pollinating insects under field conditions. Due to these perceived concerns, the use of the three neonicotinoids imidacloprid, clothianidin and thiamethoxam has been temporarily suspended in the European Union for seed treatment, soil application and foliar treatment in crops attractive to bees. Monitoring data from a number of countries are available to assess the presence of neonicotinoid residues in honey bee samples and possible impacts at the colony level and these are reviewed here together with a number of field studies which have looked at the impact of clothiandin on honey bees in relation to specific crop use and in particular with oilseed rape. Currently there is considerable uncertainty with regards to the regulatory testing requirements for field studies. Accordingly, a testing protocol was developed to address any acute and chronic risks from oilseed rape seeds containing a coating with 10 g clothianidin and 2 g beta-cyfluthrin per kg seeds (Elado®) for managed honey bee (Apis mellifera) colonies, commercially bred bumble bee (Bombus terrestris) colonies and red mason bees (Osmia bicornis) as a representative solitary bee species. This is described here together with a summary of the results obtained as an introduction to the study details given in the following papers in this issue. © 2016, The Author(s).


Bowen D.E.,JSC International Ltd. | Whitwell J.H.,Covance | Lillford L.,Covance | Henderson D.,Covance | And 5 more authors.
Mutation Research - Genetic Toxicology and Environmental Mutagenesis | Year: 2011

With the publication of revised draft ICH guidelines (Draft ICH S2), there is scope and potential to establish a combined multi-end point in vivo assay to alleviate the need for multiple in vivo assays, thereby reducing time, cost and use of animals.Presented here are the results of an evaluation trial in which the bone-marrow and peripheral blood (via MicroFlow ® flow cytometry) micronucleus tests (looking at potential chromosome breakage and whole chromosome loss) in developing erythrocytes or young reticulocytes were combined with the Comet assay (measuring DNA strand-breakage), in stomach, liver and blood lymphocytes. This allowed a variety of potential target tissues (site of contact, site of metabolism and peripheral distribution) to be assessed for DNA damage. This combination approach was performed with minimal changes to the standard and regulatory recommended sampling times for the stand-alone assays.A series of eight in vivo genotoxins (2-acetylaminofluorene, benzo[. a]pyrene, carbendazim, cyclophosphamide, dimethylnitrosamine, ethyl methanesulfonate, ethyl nitrosourea and mitomycin C), which are known to act via different modes of action (direct- and indirect-acting clastogens, alkylating agents, gene mutagens, cross-linking and aneugenic compounds) were tested. Male rats were dosed at 0, 24 and 45. h, and bone marrow and peripheral blood (micronucleus endpoint), liver, whole blood and stomach (Comet endpoint) were sampled at three hours after the last dose. Comet and micronucleus responses were as expected based on available data for conventional (acute) stand-alone assays.All compounds were detected as genotoxic in at least one of the endpoints. The importance of evaluating both endpoints was highlighted by the uniquely positive responses for certain chemicals (benzo[. a]pyrene and 2-acetylaminofluorene) with the Comet endpoint and certain other chemicals (carbendazim and mitomycin C) with the micronucleus endpoint.The data generated from these investigations demonstrate the suitability of the multi-endpoint design. © 2011 Elsevier B.V.


Elsmore R.,JSC International Ltd
Chimica Oggi | Year: 2010

Biocidal products play a vital role in controlling organisms that are harmful to man and animals and they are essential in protecting both man-made and natural products from damage and decay. Biocidal products are used in industry and in the home. They include disinfectants, insect repellents, drinking water disinfectants and the preservatives used to protect a wide range of finished products and raw materials (including wood, paints, textiles etc). Regulatory control of biocidal products has varied considerably within the EU, with some having been regulated under existing national systems while others have not been specifically controlled The Biocidal Products Directive (BPD) introduces a harmonised system of control across all member states that involves a two stage process, first with the evaluation of active substances followed by the authorisation of all products. This article examines the process of product authorisation and some important considerations when planning to place a biocidal product on the market.


Wright S.,JSC International Ltd | Elsmore R.,JSC International Ltd
Chimica Oggi/Chemistry Today | Year: 2015

From 1 June 2015, mixtures should be classified and labelled in accordance with the CLP Regulation. Companies completing the re-classification should be aware that the change in classification systems may result in a more hazardous classification under CLP than originally under the DPD system. To minimise the impact of these changes and to provide a more meaningful classification, companies can rely on more expert judgement and bridging principles than using the default calculation methods.


Elsmore R.,JSC International Ltd
Chimica Oggi/Chemistry Today | Year: 2013

The new Biocidal Products Regulation (BPR) will repeal and replace the Biocidal Products Directive (BPD) and is intended to build on the principles laid down in the BPD while introducing a number of significant changes to the way biocides are regulated within the EU. The BPR is intended to simplify and streamline existing EU requirements without reducing the level of protection offered to health and the environment. This article looks at the requirements of the BPR and some of the possible implications for industry and consumers of this new legislation.


Elsmore R.,JSC International Ltd | Wright S.,JSC International Ltd
Chimica Oggi/Chemistry Today | Year: 2014

With the entry into application of the Biocidal Products Regulation (BPR) on 01 September 2013 companies which were previously not involved with supporting active substances they supply now have the opportunity to become engaged in the regulatory process and must do so to remain in the market. This article looks at some of the options open to companies and the benefits and drawbacks of supporting an active substance through the EU biocides system.


Elsmore R.,JSC International Ltd | Wright S.,JSC International Ltd
Chimica Oggi/Chemistry Today | Year: 2016

Over recent years the legislation concerning the placing of biocidal products on the market within the EU has changed significantly. We are seeing the gradual transition from national requirements to a harmonised European system of regulation. While the new EU wide system is based on a two phase approach, initially focussing on active substances, the second phase of this process is now impacting many companies who place formulated biocidal products, such as disinfectants, on the market. The change over from the diverse national approval systems to the BPR product authorisation process is triggered by the approval of the active substances that a product contains and product authorisation will now become essential if existing products are to remain on the market or before new products can be launched. While certain biocidal products have traditionally been regulated under the old national rules in some Member States, the BPR requirement for product authorisation will impact all biocidal products that fall within scope of the BPR and represents a major change particularly for some products that may only have been lightly regulated in the past. As such, the requirements for BPR product authorisation can represent a significant challenge for companies who market these types of products. This article examines the process of product authorisation and some important considerations when planning to place a biocidal product on the market.


Elsmore R.,JSC International Ltd
Chimica Oggi/Chemistry Today | Year: 2012

Biocides encompass a broad group of substances, products (and even micro-organisms) that are used to control unwanted organisms; they include many household products including disinfectants and insecticides as well as formulations used in industry such as slimicides, cooling water biocides and even embalming fl uids that are used to preserve bodies. This article looks at the regulatory hurdles facing biocides in the EU as the existing national schemes are being replaced by product authorisation under the Biocidal Products Directive [BPD] (98/8/EC). Historically many of these products have not required authorisation in some member states under the old national rules. Just as we are coming to terms with the implementation of the BPD it is being replaced by the Biocidal Products Regulation (BPR). The article examines the changes the BPR will introduce for biocidal products.

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