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The drug development process is a lengthy and expensive challenge for all involved players. Experience with the COVID-19 pandemic underlines the need for a rapid and effective approval for treatment options. As essential prerequisites for successful drug approval, a combination of high-quality studies and reliable research must be included. To this day, mainly in vivo data are requested and collected for assessing safety and efficacy and are therefore decisive for the pre-clinical evaluation of the respective drug. This review aims to summarize the current state of the art for safety and efficacy studies in pharmaceutical research and industry to address the relevant regulatory challenges and to provide an outlook on implementing more in vitro methods as alternative to animal testing. While the public demand for alternative methods is becoming louder, first examples have meanwhile found acceptance in relevant guidelines, e.g. the OECD guidelines for skin sensitizer. Besides ethically driven developments, also the rather low throughput and relatively high costs of animal experiments are forcing the industry towards the implementation of alternative methods. In this context, the development of orally inhaled drug products is particularly challenging due to the complexity of the lung as biological barrier and route of administration. The replacement of animal experiments with focus on the lungs requires special designed tools to achieve predictive data. New in vitro test systems of increasing complexity are presented in this review. Limits and advantages are discussed to provide some perspective for a future in vitro testing strategy for orally inhaled drug products. Graphical abstract

The aim of this study was to evaluate the impact of different concentrations of copper and zinc on the mortality and bodyweight of juvenile earthworms in artificial soil. Copper was more toxic with complete mortality at the dose rate of 1000 mg/kg. Bodyweight loss of earthworms was observed immediately, after the first week, except at the lowest concentration. In comparison to control, there were significant differences in the bodyweight loss every week in the concentrations of 333 and 666 mg/kg, and also 167 mg/kg in the fourth, sixth, and eighth week. Zinc has not shown a significant effect on mortality, except in the highest concentration, where survival was less than 25%. Statistically significant effect (p < 0.05) on bodyweight was registered only at the highest concentration, every week. The impact of metals on earthworm populations should be more accurately assessed, and data for juvenile earthworms should be considered when proposing a safe concentration of pollutants in the environment, because of the great importance of these animals' presence in the soil.

The dissolution of metal-based engineered nanomaterials (ENMs) in aquatic environments is an important mechanism governing the release of toxic dissolved metals. For the registration of ENMs at regulatory bodies such as REACH, their dissolution behavior must therefore be assessed using standardized experimental approaches. To date, there are no standardized procedures for dissolution testing of ENMs in environmentally relevant aquatic media, and the Organisation for Economic Co-operation and Development (OECD) strongly encourages their development into test guidelines. According to a survey of surface water hydrochemistry, we propose to use media with low concentrations of Ca2+ and Mg2+ for a better simulation of the ionic background of surface waters, at pH values representing acidic (5 < pH < 6) and near-neutral/alkaline (7 < pH < 8) waters. We evaluated a continuous flow setup adapted to expose small amounts of ENMs to aqueous media, to mimic ENMs in surface waters. For this purpose, silver nanoparticles (Ag NPs) were used as model for soluble metal-bearing ENMs. Ag NPs were deposited onto a 10 kg.mol−1 membrane through the injection of 500 µL of a 5 mg.L−1 or 20 mg.L−1 Ag NP dispersion, in order to expose only a few micrograms of Ag NPs to the aqueous media. The dissolution rate of Ag NPs in 10 mM NaNO3 was more than two times higher for ~2 µg compared with ~8 µg of Ag NPs deposited onto the membrane, emphasizing the importance of evaluating the dissolution of ENMs at low concentrations in order to keep a realistic scenario. Dissolution rates of Ag NPs in artificial waters (2 mM Ca(NO3)2, 0.5 mM MgSO4, 0–5 mM NaHCO3) were also determined, proving the feasibility of the test using environmentally relevant media. In view of the current lack of harmonized methods, this work encourages the standardization of continuous flow dissolution methods toward OECD guidelines focused on natural aquatic environments, for systematic comparisons of nanomaterials and adapted risk assessments.

International audience; The 21st century has seen a steadily increasing social awareness of animal suffering, with increased attention to ethical considerations. Developing new integrated approaches to testing and assessment (IATA) strategies is an Organisation for Economic Co-operation and Development (OECD) goal to reduce animal testing. Currently, there is a lack of alternative models to test for ocular surface toxicity (aside from irritation) in lieu of the Draize eye irritation test (OECD guideline No. 405) performed in rabbits. Five alternative in vitro or ex vivo methods have been validated to replace this reference test, but only in combination. However, pathologies like Toxicity-Induced Dry Eye (TIDE), cataract, glaucoma, and neuropathic pain can occur after exposure to a pharmaceutical product or chemical and therefore need to be anticipated. To do so, new models of lacrimal glands, lens, and neurons innervating epithelia are required. These models must take into account real-life exposure (dose, time, and tear film clearance). The scientific community is working hard to develop new, robust, alternative, in silico, and in vitro models, while attempting to balance ethics and availability of biological materials. This review provides a broad overview of the validated methods for analyzing ocular irritation and those still used by some industries, as well as promising models that need to be optimized according to the OECD. Finally, we give an overview of recently developed innovative models, which could become new tools in the evaluation of ocular surface toxicity within the scope of IATAs.

The COVID-19 pandemic has caused various disruptions in the production chains of Multinational Enterprises (MNEs). Among other disruptions there is a drop of product sales, often due to lock-down measures, which resulted in last-minute order cancellations , non-payment of the already purchased resources and already made products, and hence terminations of employment contracts. International organisations and non-governmental organisations have called upon MNEs to take their corporate social responsibility (CSR) and honour the contracts. The aim of this article is to analyse to what extend this moral appeal is also a (quasi-)legal appeal following from international norms on CSR. After an assessment of the main labour law problems caused by the COVID-19 pandemic, an analysis follows on each of the identified problems. The conclusion of the analysis is that MNEs indeed are not only morally obliged to take their responsibility, but also based on the (quasi-)legal international CSR norms.

The COVID-19 pandemic has caused various disruptions in the production chains of Multinational Enterprises (MNEs). Among other disruptions there is a drop of product sales, often due to lock-down measures, which resulted in last-minute order cancellations, non-payment of the already purchased resources and already made products, and hence terminations of employment contracts. International organisations and nongovernmental organisations have called upon MNEs to take their corporate social responsibility (CSR) and honour the contracts. The aim of this article is to analyse to what extend this moral appeal is also a (quasi-)legal appeal following from international norms on CSR. After an assessment of the main labour law problems caused by the COVID-19 pandemic, an analysis follows on each of the identified problems. The conclusion of the analysis is that MNEs indeed are not only morally obliged to take their responsibility, but also based on the (quasi-)legal international CSR norms.

Las Líneas Directrices de la OCDE para empresas multinacionales son uno de los instrumentos que han tratado el tema de las empresas multinacionales en el plano internacional. Ofrecen una serie de recomendaciones dirigidas a promover una conducta responsable y en línea con las normas internacionales por parte de dichas empresas. Las Directrices pertenecen al ámbito del soft law, tanto en relación con los sujetos receptores activos ¿ los países adherentes- como con los pasivos - las empresas multinacionales. No crean obligaciones jurídicas para las empresas multinacionales y tampoco prevén mecanismos de responsabilidad en caso de incumplimiento. Los Estados adherentes se comprometen a promover su uso y a establecer Puntos Nacionales de Contacto, pero las Directrices tampoco les imponen ningún tipo de responsabilidad si no respetan su compromiso. La particularidad de este instrumento radica en que prevé una serie de procedimientos para su puesta en práctica, entre los que destaca el tratamiento de casos específicos por los Puntos Nacionales de Contacto, que contribuirán a resolver las quejas que se plantean acerca del posible incumplimiento de las Directrices por las empresas multinacionales. Pese a su carácter no vinculante, las Líneas Directrices de la OCDE para empresas multinacionales pueden servir como base o guía para la elaboración de normas jurídicamente vinculantes en el futuro., The OECD Guidelines for multinational enterprises are one of the instruments that have dealt with the issue of multinational enterprises at international level. The Guidelines offer a set of recommendations to multinational enterprises aimed at promoting responsible conduct consistent with applicable laws and internationally recognised standards. The Guidelines belong to the field of soft law, both in relation to the active recipients -the adheringcountries -and to the passive ones ¿multinationalenterprises. They do not create legal obligations for multinational enterprises,nor do they provide liability mechanisms in case of non-compliance. The adhering countries undertake to promote its use and to set upNational Contact Points, but the Guidelines do not impose any type of responsibility on them if they do not respect their commitment. The distinctive feature of this instrument lies in the fact that it foresees a series of procedures for its implementation. National Contact Points contribute to the resolution of issues that arise relating to the implementation of the Guidelines in specific instances. Despite their non-binding nature, the OECD Guidelines for multinational enterprises can be used as a basis or guide for the development of legally binding standards in the future., Universidad Pablo de Olavide

The paper explores how to integrate a Transnational Labour Inspectorate (‘TLI’) dealing with transnational private instruments of Multinational Enterprises (‘MNEs’) into the International Labour Organization (‘ILO’). After exploring monitoring initiatives with roots in public international organizations, we will argue that from an international law perspective on international legal personality such activities can be justified. Under the qualification of ‘subject normation’, as we dub these activities, we will argue that the ILO is the best situated locus to embed a system to inspect commitments MNEs voluntary adhere to in their CSR strategies, including Global Framework Agreements. Finally, we explain how the TLI as we envisage it could fit within the existing system of enforcement and compliance monitoring of the ILO.

Reflecting the EU approach, the United Kingdom defines CSR as voluntary but has increasingly worked to integrate social and environmental concerns into its business-focused law and policy. As a member of the OECD, the UK has actively promoted the OECD Guidelines, the UN Guiding Principles on Business and Human Rights and adheres to ISO standards. In parallel, the UK National Contact Point has seen a rise in accepted complaints against businesses and UK courts are more attuned to the complex relationship between corporate action and social responsibility. While the devolved nature of UK business law results in slightly different emphasis on corporate responsibilities across the devolved nations, both statutory and common law duties work together to ensure increased recognition of CSR. Notably, the recent landmark decision in England in Vedanta Resources Plc v Lungowe marked a tide-change on issues of jurisdiction for UK companies’ liabilities overseas. This chapter examines the underpinnings and possibilities of future reinforcement of CSR in cross-border cases in the UK.

The purpose of the article is to determine whether tax authorities were entitled to recharacterise and omit legal transactions made by taxpayers in the legal state before 1 January 2019. In particular, the article concerns the examination whether the legal basis in this respect could be derived from the OECD Transfer Pricing Guidelines for Multinational Enterprises and Tax Administrations. The authors come to the conclusion that there was no legal basis for type of action due to Article 11(1) of the Corporate Income Tax Act and lack of possibility to refer to the OECD Guidelines. It is a non-binding document and does not constitute a source of law generally applicable in Poland. Celem artykułu jest ustalenie, czy organy podatkowe były uprawnione do recharakteryzacji i pominięcia czynności prawnych dokonanych przez podatników w stanie prawnym przed 1 stycznia 2019 r. W szczególności zaś zbadanie, czy podstawą prawną w tym zakresie mogły być Wytyczne OECD w sprawie cen transferowych dla przedsiębiorstw wielonarodowych oraz administracji podatkowych. Autorzy dochodzą do wniosku, że tego rodzaju działanie było pozbawione podstaw prawnych ze względu na treść art. 11 ust. 1 ustawy o podatku dochodowym od osób prawnych oraz brak możliwości odwołania się do Wytycznych OECD. Jest to dokument o niewiążącym charakterze i nie stanowi źródła prawa powszechnie obowiązującego w Polsce.

International audience; Until now, the Draize test on rabbits has been the only test performed to anticipate ocular toxicity of pharmaceutical compounds, mainly irritation. The OECD is urging the scientific community to develop and validate alternative methods to reduce the need for animal testing. Since the models and tests used cannot reflect the entire biologic response, it is necessary to combine them into integrated approaches to testing and assessment (IATA) to obtain robust data. IATAs, along with adverse outcome pathways (AOP) that encompass molecular cascades and key events, require the best combinations of tests. This commentary manuscript describes these OECD tools and proposes original approaches for ocular surface AOP and an IATA for toxicity-induced dry eye (TIDE).

Dissertation, RWTH Aachen University, 2020; Dissertation, RWTH Aachen University, 2020, The objective of the present study was to investigate the influence of a chemical charge on the distribution and degradation of organic chemicals in water-sediment systems and in surface water. Three 14C-labelled model substances were used with 4-n-dodecylbenzene sulfonic acid sodium salt (14C-DS-), 4-n-dodecylbenzyltrimethyl ammonium chloride (14C-DA+) and 4-n-dodecylphenol (14C-DP) representing the anionic, cationic and non-ionic model substance, respectively. These model substances were characterised by a high structural similarity of their hydrophobic part, whereas the polar head carried a negative (14C-DS-), positive (14C-DA+) or no charge (14C-DP). Simulation studies following OECD guideline 308 (Aerobic and Anaerobic Transformation in Aquatic Sediment Systems) and OECD guideline 309 (Aerobic Mineralization in Surface Water - Simulation Biodegradation Test) were performed. Natural sediment and surface water were collected from a rainwater retention basin in Aachen, Germany. The behaviour of 14C-DS-, 14C-DA+ and 14C-DP in a water-sediment system was investigated over an incubation period of 120 days. After removing the water phase, the sediment was extracted sequentially using different solvents (aqueous CaCl2 solution, methanol and acetonitrile). The sediment incubated with 14C-DA+ was additionally extracted under Soxhlet conditions. After 120 days of incubation, mineralisation of 14C-DS- and 14C-DP accounted for 68% and 63% of applied radioactivity (AR), respectively. The cationic compound 14C-DA+ was mineralised to a lesser extent (6% AR). The direct bioavailability of the test substances, based on their mineralisation and portions in the CaCl2 fraction, decreased as follows: 14C-DS- > 14C-DP > 14C-DA+. NER formation was highest for 14C-DA+ (33% AR), followed by 14C-DS- (19% AR) and 14C-DP (14% AR). Half-lives (DT50) of the test substances decreased as follows: 14C-DA+ (162 days) > 14C-DS- (22 days) > 14C-DP (14 days). In order to investigate the influence of sediment particle size fractions on the degradation of the test substances, simulation studies following OECD 308 were performed using the sand, silt and clay fraction. After 14 days of incubation and across all particle fractions, higher amounts of 14C-DS- (45-60% AR) and 14C-DP (24-32% AR) were mineralised compared to 14C-DA+ (2-5% AR). The direct bioavailability of the test substances decreased in the same order as in the water-sediment study (14C-DS- > 14C-DP > 14C-DA+). The highest NER formation in the sand and silt fraction was observed for 14C-DS- (16% AR and 18% AR, respectively). In the clay fraction, NER formation was highest for 14C-DA+ (24% AR). The surface water test following OECD 309 was performed as a suspended sediment test over an incubation time of 60 days. Additionally, abiotic degradation of the test substances was examined under sterile conditions using autoclaved surface water treated with sodium azide and γ-irradiated sediment. After 60 days under non-sterile conditions, mineralised portions of 14C-DS- and 14C-DP accounted for 63% and 58% AR, respectively. Mineralisation of 14C-DA+ was considerably lower (7% AR). Under sterile conditions, mineralisation of 14C-DS-, 14C-DA+ and 14C-DP was negligible (< 0.1% AR). Highest NER formation was observed for 14C-DP (21% AR) followed by 14C-DA+ (14% AR) and 14C-DS- (9% AR). NER formation of 14C-DS-, 14C-DA+ and 14C-DP under sterile conditions accounted for 0.1%, 5.5% and 0.6% AR, respectively. Half-lives of the test substances under non-sterile conditions decreased in the following order: 14C-DA+ (13 days) > 14C-DP (1.2 days) > 14C-DS- (1 day). The results of the present study demonstrated that the fate of organic chemicals in aquatic sediment systems was influenced by their chemical charge. A positive charge leads to a reduced degradation of a chemical in water-sediment systems and in surface water and increases sorption to sediment particles. The resulting higher persistence of the positively charged test substance was also reflected by higher degradation half-lives compared to the negatively charged and neutral test substance.

MCom (South African and International Taxation), North-West University, Potchefstroom Campus, 2020 Transfer pricing rules are anti-avoidance measures that are governed by section 31 of the South African Income Tax Act No. 58 of 1962 (Income Tax Act). Section 31(6) of the Income Tax Act provides an exemption (subject to certain requirements) from applying transfer pricing rules which allows South African holding companies to finance foreign subsidiaries with interest-free loans without worrying that the loan will be deemed to bear interest as per transfer pricing rules. Section 31 of the Income Tax Act does not provide a similar exemption from applying transfer pricing rules in the case of a foreigner granting financial assistance to a resident. This was identified as a possible deficiency in the legislation since tax treatment that are more burdensome to a foreigner than a resident may potentially not be in line with the transfer pricing guidelines provided by the Organisation of Economic Co-operation and Development (OECD). This could indicate that the South African Revenue Service (SARS) failed to align the transfer pricing rules with the guidelines provided by the OECD, as was their announced intention with the changes made to section 31 of the Income Tax Act in 2012. The findings of the study indicated that the absence of an exemption for a foreigner providing financial assistance to a resident from applying transfer pricing rules may be more burdensome to foreigners than residents and therefore potentially not in line with article 24 of the OECD Model Tax Convention. It was further found that the absence or implementation of such an exemption is unlikely to affect potential investors regarding investment decisions. Double Taxation Agreements (DTA) were found not to provide relief from transfer pricing liabilities (such as withholding tax on secondary adjustment deemed dividends), which further indicate that the burden on foreigners may be unfair compared to that of residents. Masters

Las Líneas Directrices de la OCDE para empresas multinacionales son uno de los instrumentos que han tratado el tema de las empresas multinacionales en el plano internacional. Ofrecen una serie de recomendaciones dirigidas a promover una conducta responsable y en línea con las normas internacionales por parte de dichas empresas. Las Directrices pertenecen al ámbito del soft law, tanto en relación con los sujetos receptores activos &- los países adherentes- como con los pasivos - las empresas multinacionales. No crean obligaciones jurídicas para las empresas multinacionales y tampoco prevén mecanismos de responsabilidad en caso de incumplimiento. Los Estados adherentes se comprometen a promover su uso y a establecer Puntos Nacionales de Contacto, pero las Directrices tampoco les imponen ningún tipo de responsabilidad si no respetan su compromiso. La particularidad de este instrumento radica en que prevé una serie de procedimientos para su puesta en práctica, entre los que destaca el tratamiento de casos específicos por los Puntos Nacionales de Contacto, que contribuirán a resolver las quejas que se plantean acerca del posible incumplimiento de las Directrices por las empresas multinacionales. Pese a su carácter no vinculante, las Líneas Directrices de la OCDE para empresas multinacionales pueden servir como base o guía para la elaboración de normas jurídicamente vinculantes en el futuro., The OECD Guidelines for multinational enterprises are one of the instruments that have dealt with the issue of multinational enterprises at international level. The Guidelines offer a set of recommendations to multinational enterprises aimed at promoting responsible conduct consistent with applicable laws and internationally recognised standards. The Guidelines belong to the field of soft law, both in relation to the active recipients - the adhering countries - and to the passive ones – multinational enterprises. They do not create legal obligations for multinational enterprises, nor do they provide liability mechanisms in case of non-compliance. The adhering countries undertake to promote its use and to set up National Contact Points, but the Guidelines do not impose any type of responsibility on them if they do not respect their commitment. The distinctive feature of this instrument lies in the fact that it foresees a series of procedures for its implementation. National Contact Points contribute to the resolution of issues that arise relating to the implementation of the Guidelines in specific instances. Despite their non-binding nature, the OECD Guidelines for multinational enterprises can be used as a basis or guide for the development of legally binding standards in the future.

Graphical abstract, Highlights • Acute administration of 2000 mg/kg of the Pheroid® delivery system was tolerated upon intravenous administration in BALB/c mice and Sprague-Dawley rats. • Oral administration was tolerated in both acute toxicity evaluation (14-days post single dose administration) and during chronic administration (90-days dosing). • No mutagenicity was present during the Ames assay. • A statistically significant increase in creatinine levels in the sub-chronic female treatment group was observed, however no treatment related pathology was identified during histopathology. • This evaluation did not identify any risk factors present for toxicity during oral or intravenous administration of the tested formulations during acute or repeated dosing., The Pheroid® drug delivery system is now on the threshold of progressing into human clinical trials for various patented pharmaceutical applications and a systematic investigation of its toxicological properties in vitro and in vivo is thus a priority. Colloidal dispersions (nano- and microemulsions) demonstrate the ability to be adapted to accommodate either lipophilic, hydrophilic or amphiphilic drug molecules. The colloidal dispersions investigated during this evaluation has a general size of 200 nm - 2 μm, a zeta-potential of -25 mV and the main ingredient was ethyl esters of essential fatty acids. The Ames mutagenicity assay was performed on selected Salmonella thyphimurium strains TA98, TA100 and TA102. The Ames assay included S9 metabolic activation and no mutagenicity was present during the assay. The effect of acute and subchronic administration on a biological system was investigated in two species of rodent (BALB/c mice and Sprague-Dawley rats). Observations focused on the physical condition, blood biochemical analysis and the haematological profiles. Gross necropsy was performed on all the test animals. Organ weights followed by histopathology of selected organ tissues were recorded. During the acute evaluation animals showed tolerance of the maximum prescribed dose of 2000 mg/kg (according to OECD guidelines) in two rodent species after intravenous administration (absolute bioavaibility). The oral formulation was tolerated without incidents in both acute and subchronic studies. Although valuable baseline safety data was obtained regarding the Pheroid® system, future studies with the entrapped active pharmaceutical ingredients is necessary to provide a definitive safety profile.

Highlights • Evaluated standardized 40% Garcinol in Wistar rats for its safety. • Acute, sub-acute sub-chronic and reproductive/developmental toxicity study conducted. • 40% Garcinol safe up to 2000 mg/kg at single dose. • NOAEL of 40% Garcinol at sub acute, sub-chronic and reproductive/developmental study is 100 mg/kg/day., The present study was taken up to evaluate the single dose acute toxicity, 28 days and 90 days repeated dose toxicity and reproductive/developmental toxicity of standardized 40% Garcinol in experimental rodents. The studies were conducted in compliance with OECD principles of good laboratory practice, guidelines for testing of chemicals no.420, 407, 408 and 421 respectively. Single dose acute oral toxicity was conducted on female Wistar rats as sighting study step-I (300 mg/kg) & sighting study step-II (2000 mg/kg) and main study (2000 mg/kg). Sub-acute, sub-chronic and reproductive/developmental studies were conducted in Wistar rats divided equally in vehicle control, 20, 50 and 100 mg/kg dose group along with recovery groups for vehicle control and high dose. Reproductive/developmental study was carried out for minimum of 28 days and in females during pregnancy and 4 days post partum. There were no abnormal clinical signs/behavioural changes, reproductive and developmental parameters, gross and histopathological changes as well as no alteration in the body weight, body temperature, haematology and other biochemical parameters in all the four studies. 40% Garcinol has a low toxicity profile in rodents and had no observed effects under experimental conditions used.

MBA, North-West University, Potchefstroom Campus This dissertation presents an exploratory and interpretive literature study on the extent of the application of due diligence responsibility to child labourers as rights holders in the mineral supply chain. Worldwide, one million children work in hazardous mining conditions referred to as the worst forms of child labour. The incidence of child labour today more prominently occurs within the confines of complex and fragmented corporate global supply chains. The international community has widely recognised this dilemma, as a result, corporations now have a due diligence responsibility duty to respect the rights of the child to be free from economic exploitation in their global supply chain activities. In doing so, they have an obligation to identify, prevent, mitigate and remedy child labour impacts in the supply chain. The Guiding Principles/normative framework and the OECD Guidelines are recognised as the two most prominent standards that strongly require corporations to enforce this duty. While corporations have a due diligence responsibility duty to respect the rights of the child, specific to child labour impacts in the mineral supply chain, a due diligence responsibility gap nonetheless exists. Child labour in mineral supply chains occurs at the very bottom of the supply chain. Children in such contexts are therefore invisible children cut out from immediate due diligence responsibility action. As duty bearers of due diligence responsibility, corporations also normally tend to this duty from a corporate risk approach. They thereby fail to promote the rights holders' perspective for child labour in activities as such mining. The due diligence responsibility gap for child labour in the mineral supply chain is also enhanced by limited information on the relation between due diligence responsibility and the effective realisation of the rights of the child to be free from child labour in the mineral supply chain. The presence of a due diligence responsibility gap leads to an investigation on the extent to which this duty applies to child labourers as rights holders in the mineral supply chain and whether it can be used to realise the rights of the child to be free from economic exploitation. The investigation of the study eventually leads to the conclusion that due diligence responsibility as a duty to only respect the rights of the child cannot effectively realise the rights of the child in supply chain activities. It should be accompanied by duties which also require corporations to protect and fulfil the rights of the child in the supply chain. Masters

International audience; The widespread use of manufactured nanomaterials (MN) increases the need for describing and predicting their environmental fate and behaviour. A number of recent reviews have addressed the scientific challenges in disclosing the governing processes for the environmental fate and behaviour of MNs, however there has been less focus on the regulatory adequacy of the data available for MN. The aim of this paper is therefore to review data, testing protocols and guidance papers which describe the environmental fate and behaviour of MN with a focus on their regulatory reliability and relevance. Given the often identified need for modification of OECD testing guidelines, the use of these cannot per se be assigned high regulatory adequacy. Though the specific test considerations will differ between conventional chemicals and MN, the ultimate endpoints of interest are similar. The water compartment must be considered as one of the main points of entry, facilitating dispersion of MN in the environment and establishing a link to the other environmental compartments such as soil, sediment, air, and biota. Once released to water various processes like dissolution, agglomeration, heteroagglomeration, sedimentation, interaction with natural organic matter, transformation and uptake by biota are processes of high relevance for the fate of MN in water. In the review it is found that the OECD draft test guidelines for dissolution and agglomeration will greatly assist in the generation of regulatory relevant and reliable data. Gaps do however exist in test methods for environmental fate, such as methods to estimate heteroagglomeration and the tendency for MNs to transform in the environment.

European Papers - A Journal on Law and Integration, 2016 1(3), 1259-1261, European Forum Highlight of 20 September 2016, In its decision of 30 August 2016, the European Commission found that Ireland granted undue tax benefits to Apple and that the Member State is under the obligation to recover the illegal aids from the beneficiary. The decision is connected to a recent major activity of the Commission directed at investigating the tax ruling practices of Member States, in which the European Commission has heavily relied on the OECD guidelines on transfer pricing. This seems to be due to the fact that the Commission founds it difficult to elaborate a fully "European" notion of fiscal State aid.

The objective of the present study was to evaluate acute oral toxicity, subchronic toxicity, and mutagenic potential of low molecular weight galactomannans based standardized fenugreek seeds extract (LMWGAL-TF) in laboratory animals rats as per Organization for Economic Co-operation and Development (OECD) guidelines. For the acute toxicity (AOT) study, LMWGAL-TF was orally administered to Sprague-Dawley (SD) rats at a dose of 2000 mg/kg with vehicle control (VC) group (n = 5 per sex per group) as per OECD guideline no. 423. For the repeated dose toxicity study, the SD rats were orally administered with a daily oral dose of LMWGAL-TF 250, 500 and 1000 mg/kg/day with VC group (n = 15 per sex) for a period of 90 days followed by a recovery period of 28 days as per OECD guideline no. 408. The effects on body weight, food and water consumption, organ weights with hematology, clinical biochemistry, and histology were studied. The mutagenic potential of LMWGAL-TF was tested using reverse mutation assay (AMES test, OECD guideline No. 471). The LMWGAL-TF did not show mortality or treatment-related adverse signs during acute (dose 2000 mg/kg) and subchronic (90-days repeated dose 250, 500 and 1000 mg/kg) administration. The LMWGAL-TF showed oral lethal dose (LD50) more than 2000 mg/kg during AOT study. The dose of 1000 mg/kg was found as no observed adverse effect level (NOAEL) in rats during subchronic toxicity study. Furthermore, LMWGAL-TF did not show mutagenic potential in vitro. In conclusion, LMWGAL-TF was found safe during acute and subchronic (90 days repeated dose) toxicity studies in rats with no mutagenicity., EXCLI Journal;Vol. 15, 2016

Področje transfernih cen postaja čedalje pomembnejše tako z vidika mednarodnih skupin družb, ki na nivoju skupine poskušajo doseči čim nižjo davčno obremenitev, kot tudi z vidika davčnih uprav, ki stremijo k ohranjanju davčnih prihodkov in s tem k preprečevanju zmanjševanja dobičkov v posamezni državi. Bistvo transfernih cen je, da je z njimi mogoče vplivati na prenos dobička med družbami, ki pripadajo isti skupini povezanih družb v različnih državah. Zaradi navedenega v davčni zakonodaji vsesplošno velja, da morajo vse transakcije med povezanimi osebami potekati na način in skladno s pogoji, kot bi se zanje v primerljivih okoliščinah dogovorile nepovezane osebe, tj. skladno s tržnim načelom. Aktualno problematiko s področja transfernih cen predstavlja prestrukturiranje poslovanja, ki je zajeto v IX. poglavju Smernic OECD za določanje transfernih cen za mednarodna podjetja in davčne uprave. Prestrukturiranje poslovanja v smislu Smernic OCED lahko pomeni spremembo poslovnega modela (primeroma iz tradicionalnega proizvajalca/distributerja v pogodbenega proizvajalca/distributerja), prenos sredstev (predvsem neopredmetenih) ali dejavnosti družbe, prekinitev ali pomembno spremembo obstoječih pogodb. Prestrukturiranje poslovanja privede do sprememb v opravljenih funkcijah, prevzetih tveganjih in vloženih sredstvih in s tem do spremembe potenciala za doseganje dobička, kar posledično privede do vprašanja, ali je prestrukturirana družba upravičena do prejema nadomestila zaradi izpada bodočih dobičkov oziroma do nerealiziranih kapitalskih dobičkov (skrite rezerve) in posledično država rezidentstva prestrukturirane družbe do davka od prejetega nadomestila oziroma nerealiziranih kapitalskih dobičkov. Smernice OECD ne določajo časovnega trenutka plačila davka zaradi prestrukturiranja, zato se družbe in davčne uprave lahko navežejo na obstoječo sodno prakso. Na podlagi sodb Sodišča EU se mora davčnemu zavezancu omogočiti možnost takojšnjega plačila davka zaradi prestrukturiranja ali odlog plačila do dejanske realizacije kapitalskih dobičkov oziroma se davek od nerealiziranih kapitalskih dobičkov zahteva že pred dejansko realizacijo v petletnem oziroma desetletnem časovnem intervalu. Področje prestrukturiranja poslovanja v analiziranih državah, tj. Slovenija, Nemčija, Velika Britanija, Nizozemska in Avstrija, ni enotno urejeno. Največ zakonodajnih določb s tega področja vsebuje nemška zakonodaja, ostale države pa imajo področje prestrukturiranja poslovanja, kot ga obravnavajo Smernice OECD, različno implementirano v nacionalnih zakonodajah. Pričakovati je, da se bo praksa na tem področju še razvijala in davčna obravnava harmonizirala, tudi zaradi izdanih ukrepov v okviru OECD projekta BEPS, katerega namen je omejiti erozijo davčnih osnov in prenosov dobičkov med državami. Transfer pricing is becoming increasingly important from the point of view of multinational companies, which seek to achieve the lowest tax burden at the group level, and tax administrations, which strive to keep the level of taxable revenues and thus, to prevent the profit shifting to another country. Transfer pricing facilitate the transfer of profit between the related companies that are part of the same multinational group of companies. Hence, in general all transactions between related parties has to be performed in a way and under the conditions that would be agreed between non-related companies in comparable circumstances, i.e. in line with the arm’s length principle. Business restructurings represent the current issue in the transfer pricing field, which is covered in chapter IX. of OECD Transfer Pricing Guidelines for Multinational Enterprises and Tax Administrations (hereinafter OECD Guidelines). Business restructuring within the meaning of OECD Guidelines means the change of business model (for example from fully-fledged manufacturer/distributor to contract manufacturer/distributor), transfer of assets (especially intangible assets) or activity, termination or substantial renegotiation of existing arrangements. The consequence of business restructuring is reallocation of functions, risks and assets, which all affects the profit potential. From this reason it has to be determined whether the restructured company is or should be entitled to receive the compensation for the restructuring respectively whether the restructured company is entitled to book the unrealized capital gains (hidden reserves). On the other hand, this means that the residence country of restructured company will receive the tax on compensation respectively on unrealized capital gains. OECD Guidelines do not determine the time when the tax due to restructuring has to be paid and thus, the companies and tax administrations may use the existing case law. Following the European Court of Justice’s decisions the taxpayer has to be offered a choice between immediate payment of the tax and deferred taxation at the time of realization of the hidden reserves or it is also allowed that the payment of tax may be spread over a period of five or ten years before the capital gains are actually realized. Business restructuring within the meaning of OECD Guidelines is on different ways implemented between the countries that were part of the analysis, i.e. Slovenia, Germany, United Kingdom, Netherlands and Austria. It is expected that this area will be further developed and harmonized, also in light of OECD’s project BEPS, which prevents base erosions and profit shifting, which is currently a hot tax topic.

Dieser Aufsatz geht aus einer wirtschaftsethischen Perspektive der Frage nach, inwiefern es einen Ressourcenfluch gibt und mit Hilfe welcher institutionellen Vorkehrungen gegenwärtig versucht wird, armen Staaten, die über reiche Rohstoffvorkommen verfügen, eine nachhaltige Entwicklung zu ermöglichen. Die Argumentation gliedert sich gedanklich in 3 Schritte: (a) Ausgehend von Paul Colliers 5-Stufen-Modell wird erläutert, dass die nachhaltige Nutzung natürlicher Ressourcen ein „weakest-link“-Problem darstellt. So wird verständlich, dass Entwicklungsländer auf äußere Hilfe in Form von New-Governance-Initiativen angewiesen sind. (b) Sodann wird der Kimberley-Prozess als New-Governance-Initiative vorgestellt. Hier zeigen sich deutlich die Schwächen, die bei dem Versuch auftreten können, in trisektoraler Zusammenarbeit von staatlichen, wirtschaftlichen und zivilgesellschaftlichen Akteuren neue Regelsysteme mit verbesserten Anreizwirkungen ins Werk zu setzen. (c) Abschließend wird anhand von „EITI“ und anhand der „OECD Guidelines“ sowie anhand zahlreicher weiterer Initiativen gezeigt, wie gegenwärtig versucht wird, ein globales Regulierungsregime aufzubauen, das auf eine nachhaltige Entwicklung zielt. Taking the perspective of economic ethics, this article asks whether there is a resource curse and which institutional arrangements are currently organized in order to help countries that are rich in resources but still poor to experience sustainable development. The line of argumentation proceeds in three steps: (a) Starting with Paul Collier‘s fivelevel model, section I explains why the sustainable use of natural resources constitutes a „weakest-link“ problem. This helps to understand why developing countries need support from outside, especially in form of „new governance“ initiatives. (b) Section II introduces the Kimberley Process as a „new governance“ initiative. The discussion shows how difficult and crisis-prone the attempt can be to institutionalize better incentives via tri-sectoral partnerships between state actors, business firms and civil society organizations. (c) Finally, section III analyzes „EITI“, the „OECD Guidelines“ and several other initiatives in ordert o reconstruct the current approach to institute a global regime of rules that aim to foster sustainable development.

In the last two decades the production and use of nanomaterials (NMs) has impressively increased. Their small size, given a mass equal to that of the corresponding bulk material, implies an increase in the surface area and consequently in the number of atoms that can be reactive. They possess different physical, chemical and biological properties compared to bulk materials of the same composition, which makes them very interesting and valuable for many different applications in technology, energy, construction, electronics, agriculture, optics, paints, textiles, food, cosmetics, medicine... Toxicological assessment of NMs is crucial; the same properties that make them interesting also make them potentially harmful for health and the environment. However, the term NM covers many different kinds of particle , and so there is no simple, standard approach to assessing their toxicity. NMs can enter the cell, interact with cell components and even penetrate the nucleus and interfere with the genetic material. Among the different branches of toxicology, genotoxicity is a main area of concern since it is closely related with the carcinogenic potential of compounds. The Organisation for Economic Co-operation and Development (OECD) has published internationally agreed in vitro and in vivo validated test methods to evaluate different genotoxic endpoints of chemicals, including chromosome and gene mutations, and DNA breaks. However not all the assays are suitable to study the genotoxic potential of NMs as has been shown by the OECD Working Party on Manufactured Nanomaterials (WPMN). Moreover, alterations to DNA bases, which are precursors to mutations and of great importance in elucidating the mechanism of action of NMs, are not covered by the OECD guidelines. The in vivo standard comet assay (which measures DNA breaks and alkali-labile sites) was included in the OECD assays battery in September 2014 while the in vitro standard comet assay is currently under validation. The comet assay has not been yet proposed as an appropriate test to check the genotoxic potential of NMs, though at a research level it is the most used in vitro assay and the second most used in vivo assay. Moreover, the combination of the comet assay with enzymes that convert altered bases to breaks allows the identification of DNA damage induced by secondary mechanisms (e.g. oxidative stress induced by inflammation), which is very relevant in the case of NMs. Possible problems with the use of the comet assay have been suggested: NMs have been detected in close association with comets, and might interact with the DNA; or NMs might inhibit the action of enzymes. However, control experiments have not confirmed that these interactions are significant.

The purpose of this study is to answer the research question of how a service company (ServiceCo) could achieve a transfer price of its services. This is of particular interest, due to the growth of service firms that have rapidly increased and surpassed the manufacturing firms, as well as the dominant logic shifting towards services. However, the problem with this field of study is that transfer pricing with regards to the service industry, is a rather unexplored phenomenon in which the guidelines and theories are mostly directed towards manufacturing firms. This study uses a single case study approach where ServiceCo’s organizational characteristics were analyzed in order to attain the information required to understand how ServiceCo could achieve a transfer price of its services. Furthermore, this study uses the Eccles (1983) MAP and the OECD Guidelines, as well as incorporating Porter’s (1985) value chain. This study assesses that ServiceCo, in its current state, uses a sub-optimal transfer pricing method of its services. Therefore, a change in the transfer pricing method was suggested to ServiceCo. Given the organizational characteristics of ServiceCo, the results led to the conclusion that ServiceCo could benefit from a residual analysis in the profit split method, in which an actual full cost plus mark-up compensation could be used on its routine functions, and the residual profit could be split between the entities based on the intangible assets employed, functions performed and the risks carried.

Nanosponges (NS) show promising results in different fields such as medicine, agriculture, water purification, fire engineering and so on. The present study was designed to evaluate toxicity of different NS formulations (namely, S1-S6) synthesized with different cross-linking agents such as carbonyl diimidazole, pyromellitic dianhydride and hexamethylene diisocynate; and preparation methods in experimental animals. Acute and repeated dose toxicity studies of formulations were carried out as per OECD guidelines 423 and 407, respectively. For acute toxicity study, formulations were administered to female rats at doses of 300 and 2000 mg/kg orally. The general behaviour of the rats was continuously monitored for 1 h after dosing, periodically during the first 24 h and daily thereafter for a total of 14 days. On day 14, animals were fasted overnight, weighed, and sacrificed. After sacrification, animals were subjected to necropsy. For repeated dose toxicity study, rats of either sex were orally administered with formulations at the dose of 300 mg/kg per day for a period of 28 days. The maximally tolerated dose of all formulations was found to be 2000 mg/kg. Repeated administration of formulations for 28 days did not show any significant changes in haematological and biochemical parameters in experimental animals. These results indicate that the formulations are safe, when tested in experimental animals.

Metode dolo?anja transfernih cen Transfer Pricing Methods

SUMMARY: 1. Introduction. – 2. Public Monitoring vs Private Monitoring. – 3. Initiatives for Monitoring Systems by International Organizations. – 3.1. Initiatives by Public Organizations. – 3.1.1. ILO: Tripartite Declaration of Principles Concerning Multinational Enterprises and Social Policy. – 3.1.2. OECD: Guidelines for Multinational Enterprises. – 3.1.3. UN: Global Compact and The Ruggie Framework. – 3.2. ILO Convention 81 Labour Inspection. – 4. Monitoring Systems as Found in Private Initiatives Applied in Practice. – 4.1. CSR Codes of Conduct. – 4.2. International Framework Agreements. – 4.3 Monitoring Initiatives by NGOs. – 4.4. Concluding Remarks on Transnational Private Monitoring Systems. – 5. Discussion of Previous Proposals by Other Scholars. – 6. Transnational Labour Inspection: Our Proposal and Idea. – 7. Conclusions. – 8. References.

MCom (South African and International Taxation), North-West University, Potchefstroom Campus, 2014 Deviations from arm’s length prices (prices charged between independent persons) charged between connected cross-border companies are corrected by primary transfer pricing adjustments, effected by the tax authorities of a country, resulting in secondary transactions classified as constructive loans, constructive dividends or constructive equity contributions. Tax could be imposed on the secondary transaction, giving rise to a secondary adjustment. For years of assessment commencing on 1 April 2012 secondary transactions, previously regarded as constructive dividends with Secondary Tax on Companies, were amended to be treated as constructive loans with interest adjustments. The primary research problem addressed by this literature study was to establish whether the constructive loan is the appropriate treatment of secondary transfer pricing transactions in the South African context and if not, whether the other alternatives suggested by the Organisation for Economic Co-operation and Development (“OECD”) guidelines should be considered. The OECD suggests that a transaction should be characterised in accordance with its substance. Determination of the subjective economic substance may be established by the motives of multinational groups for setting transfer prices. Multinational groups could have various motives for setting transfer prices that deviate from the arm’s length principle, influencing the economic substance of secondary transactions. In order to determine if the treatment of a secondary transaction, as a constructive loan, would be appropriate and reflect the economic substance of adjustments arising as a result of these motives, the characteristics of each alternative were analysed. The characteristics determined for each of the alternatives were then applied to the economic substance arising from a motive, to determine the appropriateness of each of the alternatives as a secondary transaction. Based on the motives for entering into these transactions, an analysis was performed. The findings led to the conclusion that in the case of the economic substance of transactions, which give rise to transfer pricing adjustments, a constructive dividend appears to be the appropriate treatment for a secondary transaction in most circumstances, as opposed to the constructive loan currently applied by South Africa. Constructive loans or constructive equity contributions may be reflective of the economic substance in exceptional circumstances. The study makes recommendations that South Africa should consider amending the current treatment of a secondary transaction as a constructive loan, to a constructive dividend. It was also recommended that overlapping criteria in the dividend definition be eliminated and that further research should be undertaken in order to determine how the exceptional circumstances for characterisation as a constructive loan or constructive equity contribution, should be provided for in the Income Tax Act (58 of 1962). Masters

Ever since its constitution the ILO has developed and maintained a system of labour standards in order to create decent work all over the world. With the globalisation of the economy multinationals have gained an important position in furthering these labour standards throughout their value chains. From a regulatory point of view this development has resulted in a panoply of law and law-like initiatives within the global space in order to implement the labour standards. Much is already known about these initiatives from an individual and isolated perspective. Yet, little is known about their interactions in the global space. Whereas the concept of global space acknowledges the coexistence of different regulatory forms serving different roles, the concept of hybrid structures acknowledges the fact that these regulations interact in several configurations. The aim of this contribution is to map the main regulatory initiatives, to analyse their different roles in the global space of labour standards and to analyse in which configurations they interact. The findings of this analysis provide a more advanced and comprehensive understanding of the regulation of labour standards on the global level.

Transfer pricing in related-party transactions, represent one of the most actual area in contemporary business. Itˈs different from prices that are arranged between unrelated companies for comparable transaction in equal circumstances. Itˈs used in profit transferring for minimazing tax burden and maximizing consolidate profit. In 1995 OECD established transfer pricing guidelines for multinational companies and tax administrations on international level. From tax aspect, the most important matter is to document and determine transfer prices with appropriate method because of proving the armˈs lenght principle. Worldwide, the focus is on their audit and control (North and Latin America, Asia-Pacifik). The most important procedures for dispute resolution are cost sharing agreements, advance pricing agreements and mutual agreement procedures. Tax administrations in European Union also strengthen transfer pricing audits by adopting Codes of conduct. Joint transfer pricing forum works on consensus principle in order to resolve transfer pricing practical problems. In Republic of Croatia, first transfer pricing regulation is established in 2005. OECD guidelines are implemented in corporate tax law, itˈs regulation and common tax law, but also in 2009. Tax administration published Manual for transfer pricing audit. The purpose of this paper is to analyze transfer pricing, which can not be cancelled, but itˈs necessary more detailed and concrete transfer pricing institucional determine.

Thesis (MCom (South African and International Taxation))--North-West University, Potchefstroom Campus, 2013 Multinational enterprises have been widely accused of using aggressive tax planning schemes to avoid paying tax all over the world. The purpose of this study is to analyse the methods used by multinational enterprises in the context of business restructurings to shift profits from high to low tax jurisdictions. Transactions between associated entities have generally been manipulated by applying non-arm’s length prices to these transactions, as well as devising agreements where the economic substance varies from the form of the transaction. The study aims to investigate some of the practical challenges faced by tax administrators in the application of the arm’s length principle. The study was conducted based on a literature review, as well as analysing specific examples reported in newspapers where multinational enterprises have used aggressive tax planning schemes to shift profits. International case law was also analysed to evaluate some of the factors considered by the courts in the determination of the arm’s length price. It was found that multinational enterprises definitely use aggressive tax planning schemes to shift profits. The practical challenges in the determination of arm’s length prices, complexity of the transactions involved, as well as a lack of resources, especially in the developing nations, are some of the factors that cause tax administrators to battle to find a solution to deter and detect these schemes. Other methods such as the unitary taxation method and the country by country reporting concept have been brought forward as alternatives to the arm’s length principle. These alternatives have been proposed in an effort to find a solution to the challenges posed by the arm’s length principle. Specific measures have also been recommended for developing nations’ tax administrators to resolve the issues that they currently experience in this context. Masters

Decision-making process on the optimization of transfer pricing has two dimensions that need to be considered: optimization dimension in terms of available capacity, tax laws of countries, available market and other indicators of the individual company, and dimension of transfer pricing regulation at the international level in accordance with the OECD Guidelines. Current multiplefactor transfer pricing model examines only the first dimension of transfer pricing between related parties. Transfer price method, expressed in a form of transfer pricing model using the transactional net margin method, is built in a multiple-factor transfer pricing model in order to meet the conditions of transfer prices at arm’s length principle. In this way a new transfer pricing model is formed; a model that optimizes the operations of multinational companies and is in line with the OECD Guidelines on transfer prices., Donošenje odluke o optimizaciji transfernih cijena ima dvije dimenzije koje je potrebno sagledati: dimenziju optimizacije u smislu raspoloživih kapaciteta, poreznih propisa zemalja, raspoloživog tržišta i ostalih individualnih pokazatelja pojedinog društva, te dimenziju reguliranja transfernih cijena na međunarodnoj razini sukladno Smjernicama OECD-a. Postojeći model višestrukih čimbenika transfernih cijena ispituje prvu dimenziju optimizacije transfernih cijena između povezanih osoba, bez uvažavanja druge dimenzije. Metoda transfernih cijena izražena u obliku modela formiranja transferne cijene korištenjem metode neto dobitka u odnosu na određenu osnovu, ugrađena je u model višestrukih čimbenika transfernih cijena u cilju zadovoljavanja uvjeta formiranja transfernih cijena po principu produžene ruke. Na taj je način dobiven novi model transfernih cijena koji optimizira poslovanje multinacionalne kompanije i sukladan je Smjernicama OECD-a o tranfernim cijenama.

El comportamiento en el ámbito fiscal de las empresas multinacionales ha sido regulado por los Estados a través de la determinación de los precios de transferencia. En el caso del marco jurídico en México, se han establecido normas fiscales y financieras durante los últimos años, principalmente después de la incorporación de México a la Organización para la Cooperación y Desarrollo Económico (OCDE). El objetivo de este trabajo es mostrar cómo los lineamientos internacionales de la OCDE han incidido en la legislación mexicana, particularmente en la Ley del Impuesto Sobre la Renta, estableciendo un tratamiento especial del régimen fiscal y precios de transferencia, aunado al análisis del uso las bases de datos cuando el contribuyente se encuentra colocado en hecho generador. Este tema tributario es de mucha importancia en México, ya que repercute en las arcas del erario federal. Multinational enterprises behaviour in the field of taxation has been regulated by the State through the determination of transfer pricing. In the Mexican legal framework, fiscal and financial rules have been established in recent years, mainly after the incorporation of Mexico to the Organization for Economic Co-operation and Development (OECD). This paper aims at showing how the OECD’s international guidelines have influenced Mexican laws, particularly the Income Tax Act, establishing a special treatment of tax and transfer pricing, adding the analysis of database use when the taxpayer is subject to taxable event. This tax issue is very important in Mexico because it affects the federal treasure. 5-20 marcelaa@servidor.unam.mx quetamancillamx@yahoo.com.mx

Three decades have passed since the Organisation for Economic Co-operation and Development (OECD) promulgated Guidelines on the Transborder Flows of Personal Data , and still the issue of transborder flows of personal data continues to plague policymakers, industry, and individuals who have no idea what happens to their data once that data is transmitted beyond their national jurisdictions. This article briefly reviews what happened in the 1970s, the factors that led to production of the guidelines, and some of the key points in them. We highlight the success of the guidelines, but also the shortcomings, and what is happening now to bridge the gap and ask whether an international binding convention or standard is needed. We conclude with a few modest suggestions for ensuring a new convention or standard has teeth. In the 1970s, the decade before the OECD Guidelines were promulgated, some countries had already begun to enact privacy laws applicable to the public and private sectors. The world's first data protection law was passed in the German Land of Hessen in 1970. In 1977, a Federal Data Protection Act (Bundesdatenschutzgesetz or BDSG) followed. Sweden's Data Act of 1973 was the first comprehensive national act on privacy in the world. France's Data Protection Act, enacted in 1978 and amended in 2004, covers personal information held by government agencies and private entities. In the U.S., antecedents of the 1974 Privacy Act were the American Fair Credit Reporting Act of 1970 and a 1973 report of the Department of Health Education and Welfare (HEW) on fair information practices (FIP). In the seven-year stint between 1973 and 1980, one-third of the OECD's 30 Member countries enacted legislation intended to protect in dividuals against abuse of data related to them and to give individuals the right of access to data with a view to checking their accuracy and appropriateness. Some countries were enacting statutes that dealt exclusively with computers and computer-supported activities. Other countries preferred a more general approach irrespective of the particular data processing technology involved. The OECD became concerned that these disparities in legislation might "create obstacles to the free flow of information between countries." The OECD Council recognized that Member countries have a common interest in protecting privacy "and in reconciling fundamental but competing values such as privacy and the free flow of information." This persisting tension between data protection and the free flow of information is already obvious in the OECD Guidelines of 1980, which were intended to facilitate a harmonization of national legislation, without precluding the establishment of an international Convention at a later date. As it turned out, the Council of Europe (CoE), another international organization mainly concerned with the fostering of human rights and democracy in Europe, was working simultaneously in that direction---that of an international convention. As European countries began to adopt data protection laws, pressure grew for more uniformity of these laws. From a human rights perspective, the CoE began preparing an international convention on data protection that nevertheless also included provisions dealing with data processing abroad. Efforts were made to avoid unnecessary differences between the texts produced by the two organizations; thus, the set of basic principles of protection proposed by the OECD and the CoE are similar in many respects. On Sept. 17, 1980, the Committee of Ministers of the CoE adopted the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data, the first legally binding international instrument in data protection. The convention sought to establish basic principles of data protection, to reduce restrictions on transborder data flows on the basis of reciprocity, and to bring about cooperation between national data protection authorities (DPAs). Parties to the convention are required to apply the principles in their domestic legislation. Six days later, on Sept. 23, 1980, the OECD Council adopted its guidelines on transborder data flows. Although efforts were made to minimize the differences, some do occur nevertheless. The OECD Guidelines are not legally binding, whereas the CoE convention is binding on those countries that ratify it. The CoE convention only applies to personal data that are "automatically" processed, whereas the guidelines are valid for the processing of data in general, irrespective of the particular technology employed. The OECD Guidelines, unlike the CoE convention, do not mention the need to establish national data protection authorities, a crucial requirement in European data protection rules. But, all in all, the principles formulated are similar. The OECD Guidelines and the CoE convention both recognize the need to harmonize data protection standards. Like the CoE convention, the OECD Guidelines aimed to prevent interruptions in the international flow of data, but are not to be construed as a set of general privacy protection principles per se. The guidelines explicitly say that invasions of privacy by candid photography, physical maltreatment, or defamation are outside their scope.

Background International transfer pricing has been a highlighted issue during the last decades as country after country has revised and introduced new transfer pricing laws as a respond to the expanded globalization. Several countries are adopting similar approaches and the prime guiding principles are provided by the Organization for Economic Co-Operation (OECD). The international law as well as the laws of all 30 member countries is based on the OECD Guidelines. Purpose The purpose of this master’s thesis is to describe differences and similarities regarding the transfer pricing regulations in China and Sweden and to explain how a Swedish multinational enterprise (MNE) have to utilize and adjust their transfer pricing strategy when trading with group companies in China. The results then conclude into a step model for strategic transfer pricing. Result The differences between the regulations are mainly uncovered in the definition of associated parties and associated interest. The differences in the regulations are thus of minor importance and does not affect a Swedish MNE to any major extent. The challenging area is instead the conflict between the tax authority and the customs service. To enable this study, three Swedish MNEs are used as a case study. We discovered that all had very different transfer pricing strategies even though they are within the same industry and two of them even within same range of products. Out of this we made the conclusion that the strategy chosen is not just depending on what product or service you trade with but also the aim and purpose, the range of products and the structure of the company. International transfer pricing is a very complex issue that goes into nearly all business operations. The concept of transfer pricing can thus be broken down and simplified if the demands from the company is minor.

El marco jurídico en México ha establecido normas fiscales que regulan los precios de transferencia, principalmente después de la incorporación a la Organización para la Cooperación y Desarrollo Económico (OCDE). El propósito de este estudio es mostrar los lineamientos en el derecho fiscal mexicano, sobre las reglas que la administración tributaria sigue en las auditorías tributarias a los grandes contribuyentes (empresas multinacionales), en materia de precios de transferencia; y, a su vez, cómo las Guías de la OCDE han incidido en la legislación mexicana, sustancialmente en la Ley del Impuesto Sobre la Renta (ISR) y Código Fiscal de la Federación, estableciendo un tratamiento especial en el régimen fiscal. Se trata de un estudio fiscal documental, basado en la normatividad vigente, con fuentes originales y oficiales, así como libros y revistas de los diversos autores que han estudiado el tratamiento especial de los precios de transferencia en México, acercándose la administración tributaria mexicana a los lineamientos de la OCDE. The legal framework in Mexico has established tax rules that regulate transfer pricing, especially after joining the Organization for Economic Cooperation and Development (OECD). The purpose of this study is to present the guidelines in Mexican tax law, regarding the rules followed by the tax administration when auditing large taxpayers (multinational enterprises) concerning transfer pricing issues, and in turn, how OECD Guidelines have influence Mexican Law, significantly in Income Tax Law (ISR) and the Federal Tax Code, establishing a special handling in the tax system. This is a documented fiscal study, based on current regulations, with original and official sources, as well as books and journals by various authors who have studied the select treatment of transfer pricing in Mexico, the Mexican tax administration approaching the OECD guidelines. O marco jurídico no México tem estabelecido normas fiscais que regulam os preços de transferência, principalmente após a incorporação na Organização para a Cooperação e Desenvolvimento Econômico (OCDE). O propósito deste estudo é mostrar as diretrizes do direito fiscal mexicano que sobre as regras a administração tributaria segue nas auditorias tributarias aos grandes contribuintes (empresas multinacionais), em matéria de preços de transferência; e, por sua vez, a forma como as Guias da OCDE tem incidido na legislação mexicana, substancialmente na Lei do Imposto de Renda (IDR) e Código Fiscal da Federação, estabelecendo um tratamento especial no regime fiscal. Tratase de um estudo fiscal documental, baseado na normatividade vigente, com fontes originais e oficiais, assim como nos livros e revistas dos diversos autores que tem estudado o tratamento especial dos preços de transferência no México, aproximandose a administração tributária mexicana para as diretrizes da OCDE.

Background International transfer pricing has been a highlighted issue during the last decades as country after country has revised and introduced new transfer pricing laws as a respond to the expanded globalization. Several countries are adopting similar approaches and the prime guiding principles are provided by the Organization for Economic Co-Operation (OECD). The international law as well as the laws of all 30 member countries is based on the OECD Guidelines. Purpose The purpose of this master’s thesis is to describe differences and similarities regarding the transfer pricing regulations in China and Sweden and to explain how a Swedish multinational enterprise (MNE) have to utilize and adjust their transfer pricing strategy when trading with group companies in China. The results then conclude into a step model for strategic transfer pricing. Result The differences between the regulations are mainly uncovered in the definition of associated parties and associated interest. The differences in the regulations are thus of minor importance and does not affect a Swedish MNE to any major extent. The challenging area is instead the conflict between the tax authority and the customs service. To enable this study, three Swedish MNEs are used as a case study. We discovered that all had very different transfer pricing strategies even though they are within the same industry and two of them even within same range of products. Out of this we made the conclusion that the strategy chosen is not just depending on what product or service you trade with but also the aim and purpose, the range of products and the structure of the company. International transfer pricing is a very complex issue that goes into nearly all business operations. The concept of transfer pricing can thus be broken down and simplified if the demands from the company is minor.

We study the impact of transfer pricing rules on sales prices, firms’ organizational structure, and consumers’ utility within a two-country monopolistic competition model featuring source-based profit taxes that differ across countries. Firms can either become multinationals, i.e., they serve the foreign market through a fully controlled affiliate; or they can become exporters, i.e., they serve the foreign market by contracting with an independent distributor. Compared to the benchmark cases, where tax authorities are either unable to audit firms or where they are able to audit them perfectly, the use of the OECD’s Comparable Uncontrolled Price (CUP) or Cost-Plus (CP) rule distorts firms’ output and pricing decisions. The reason is that the comparable arm’s length transactions between exporters and distributors, which serve as benchmarks, are not efficient. We show that implementing the CUP or CP rules is detrimental to consumers in the low tax country, yet benefits consumers in the high tax country.

Om to år forventer Syddansk Universitet og DHI at komme igennem nåleøjet i OECD og få godkendt en testmetode, der kan afsløre skadevirkningerne på dyr fra både nye og allerede kendte kemiske stoffer som phthalater, vækstfremmere, kemiske filtre i solcremer og parabener.»Vores dyrearter skal beskyttes. Derfor er det væsentligt at udvikle metoder, der kan teste miljøpåvirkningen fra nogle af de tusindvis af kemikalier, vi er omgivet af,« siger cand.scient. i biologi Henrik Holbech.Testen hedder FSDT - Fish Sexual Development Test - og kan vise, hvor meget fisks hormonforhold og kønsudvikling påvirkes under opvækst i vand med et bestemt kemikalie. I værste fald kan følsomme fiskearter blive udryddet, hvis kemien gør, at alle fiskeungerne kun bliver til hunner eller kun bliver til hanner.FSDT-metoden virker ved at bestemme kønnet og måle indholdet af en bestemt protein, vitellogenin, i fiskeungerne, når de er 60 dage gamle.Vitellogenin dannes normalt kun i hunfisk, fordi det populært sagt anvendes som madpakke til de æg, som hunfisk lægger. Hannerne har genet til produktion af vitellogenin, men produktionen aktiveres ikke.Hvis de unge fiskefyre forstyrres hormonelt af stoffer som phthalater eller parabener, begynder også de at danne vitellogenin.»Ved hjælp af testen kan vi altså afsløre om et kemikalie, som vi har en mistanke til, virker hormonforstyrrende. I værste fald udvikler alle fiskene sig til hunfisk - eller omvendt,« siger Henrik Holbech.Metoden kan undersøge for både østrogen- og testosteronvirkninger og antivirkninger. Det er også relevant for mennesker, for påvirkes fisk, er der også en stor risiko for, at mennesker kan rammes.»Det unikke er, at testen er meget følsom, helt ned til nanogramniveau. Det er vigtigt, fordi naturen kan være følsom over for selv ekstremt små koncentrationer af kemi.«I Danmark fjerner renseanlæggene i byerne mange af de hormonforstyrrende stoffer, mens spildevandet i landzonerne kan ende i åer og bække urenset via sivebrønde.»Vi ser forhøjede niveauer af vitellogenin hos fisk, uden at vi ved hvorfor,« siger Henrik Holbech.OECD godkender disse metoder, for at hvert medlemsland ikke skal udvikle hver deres - og samtidig skal landene anerkende resultater fra godkendte test. Udviklingen af FSDT-testen er støttet af Nordisk Ministerråd og Miljøstyrelsen i Danmark. Udgivelsesdato: 18/9

Human pharmaceutical active ingredients that are orally or parenterally administered may be metabolised in the body and after excretion may be further transformed in the receiving environmental compartments. The optimal outcome from an environmental point of view—complete mineralisation—is rarely observed. Small molecule pharmaceuticals are commonly not readily biodegradable according to Organisation for Economic Cooperation and Development (OECD) 301 tests. However, primary transformation is often observed. To gain information on the transformation of active ingredients in the environment, long-term studies like transformation in aquatic water/sediment systems according to OECD guideline 308 are required for the environmental risk assessment for human active pharmaceutical ingredients. Studies received until mid 2010 as part of the dossiers for marketing authorisation applications were evaluated concerning transformation products. The evaluation revealed that in 70 % of the studies, at least one transformation product (TP) is formed above 10 % of the originally applied dose, but in only 26 % of the studies are all TP identified. The evaluation also revealed that some TP of pharmaceutical active ingredients show a considerably longer DT50 compared to the parent compound. An example is the TP (val)sartan acid that is formed from an antihypertensive compound.