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ECHA encourages SME registrants to verify their company size
The European Chemicals Agency (ECHA) is encouraging companies and only representatives (OR) to re-examine the company size they have declared in REACH-IT at the submission of their dossiers. In line with the REACH Fee Regulation, ECHA is checking the cases of companies identifying themselves as micro, small- or medium-sized. ECHA may ask companies to prove their SME status and if they fail to do so, they will be charged the full REACH fee or the fee applicable to their revised size. ECHA will start collecting an administrative charge for any incorrect SME registration in the coming months. To this effect, the Agency has submitted a draft Management Board (MB) decision for the approval of the European Commission. The exact level of the administrative charge will be determined accordingly. The ECHA website has a new page dedicated to SMEs, which provides an on-line tool enabling companies to check whether they comply with the EU definition of an SME together with clear guidelines to follow in case they need to revise their SME status. For further information go to: http://echa.europa.eu/sme_en.asp
ECHA, 29 July 2010 http://echa.europa.eu
How to Make Valid Confidentiality Claims
The European Chemicals Agency (ECHA) has recently released a new manual – How to Make Confidentiality Claims and Write Confidentiality Claim Justifications under REACH. The new manual details how to make confidentiality claims in REACH Registration dossiers and how to write justifications for these claims. This new manual gives step-by-step instructions on how to make confidentiality claims for information in a REACH Registration Dossier for requesting non-publication of information under Article 119(2) of the REACH Regulation. In addition, the manual outlines the procedure that will be followed by ECHA to assess the confidentiality claims and to potentially reject them by formal decisions, as well as the means by which registrants can submit a request for review of decisions rejecting confidentiality claim requests. Furthermore, to assist registrants, a confidentiality claim justification template is included in the manual. This template, which can now be found on ECHA’s website, will help registrants to ensure their confidentiality claim justifications contain all the required elements. In certain circumstances the IUPAC chemical name can be claimed as confidential (see REACH Article 119 (2f and 2g). Registrants who claim confidentiality of the IUPAC name are requested to provide a ‘public name’ for the substance in the registration dossier for the use by ECHA when disseminating information on the substance according to REACH Article 119. The public name should disclose a maximum amount of information on the chemical structure of the substance, whilst protecting those features of the chemical structure that are considered confidential and the disclosure of which would potentially harm the registrant. ECHA is currently analysing various naming systems and intends to issue, in due course, a practical guide on how to derive a ‘public name’. For a copy of the new manual go to: http://echa.europa.eu/doc/reachit/dsm_16_confidentiality_claims.pdf and the Confidentiality Claim Template and instructions:
ECHA, 30 July 2010 http://echa.europa.eu
Update on the ECHA Data Sharing Web pages
The European Chemical Agency’s data sharing web pages have been updated. Details on how companies can contact ECHA when data on vertebrate animal studies are not shared in a SIEF, before or after the submission of the joint registration dossier have also been provided. There is a new web form available to notify this type of data sharing dispute to ECHA. To facilitate finding information relating to data sharing disputes, ECHA has transferred the information contained in its web pages to a Questions & Answers on Data sharing and related disputes. Potential registrants of the same substance must share at least data involving tests on vertebrate animals in order to meet their information requirements for the purpose of registration. It is the responsibility of the negotiating parties to make every effort to reach an agreement on the costs of sharing that information in a fair, transparent and non discriminatory way. ECHA can assist companies that, in spite of their efforts, have failed to reach an agreement on data sharing. However, the parties involved should exhaust all options for negotiations before seeking ECHA assistance. Potential registrants involved in a data sharing dispute shall always obtain a decision from ECHA granting the permission to proceed with registration in spite of the dispute, before submitting their registration dossier. As a result, ECHA encourages particularly all SIEF members to implement their data sharing obligations in a timely manner. Especially in relation to registrations required by 1 December 2010, negotiations must be conducted without delay, even if the joint submission dossier is still being completed. Potential registrants subject to the first registration deadline should exhaust the negotiations and inform ECHA about any disputes before the end of September 2010, if they wish to obtain a decision from ECHA before that deadline. The applicant will have to complete a webform and will have to provide appropriate documentary evidence to demonstrate the efforts made to reach agreement. ECHA will then contact the other negotiating party to get its feedback. ECHA will then assess the efforts of all the parties to meet their obligation to reach an agreement on sharing the data. Finally, ECHA will decide whether granting or not a permission to refer to the data disputed in order to proceed with the registration. The registrants or potential registrants that do not comply with their data sharing obligations may also be subject to financial penalty by the enforcement authorities of the Member State where they are established. Further details can be found at: http://www.echa.europa.eu/datasharing_en.asp
Web form to indicate failure of data sharing on a vertebrate animal study: https://comments.echa.europa.eu/comments/article303.aspx
“Questions and answers on how ECHA can help in case of data sharing disputes:” http://echa.europa.eu/doc/datasharing/datasharing_q_a.pdf
ECHA, 30 July 2010 http://echa.europa.eu
Collection of waivers and standard phrases
The European Chemicals Industry Council (CEFIC) has put together a list of waivers and standard phrases, which is intended to assist potential REACH registrants when filling in the registration dossier. This list has been developed by companies doing actual registrations Please note that these standard statements are by no means intended to be mandatory or prescriptive. This table is meant to provide an overview of examples and it should not be used as a stand-alone document. It should be used in combination with the available guidance from ECHA and the relevant Annexes of the REACH Regulation.
To view table go to: http://cefic.org/templates/shwPublications.asp?HID=750
The European Chemicals Industry Council, 29 July 2010 http://www.cefic.org
Janet’s Corner – Not too seriously!
Top 10 Reasons Computers Must Be Male
10. They have a lot of data but are still clueless.
9. A better model is always just around the corner.
8. They look nice and shiny until you bring them home.
7. It is always necessary to have a backup.
6. They’ll do whatever you say if you push the right buttons.
5. The best part of having either one is the games you can play.
4. In order to get their attention, you have to turn them on.
3. The lights are on but nobody’s home.
2. Big power surges knock them out for the night.
1. Size does matter.
Please note: articles for Janet’s Corner are not original, and come from various sources. Author’s credits are supplied when available.
Three contaminants linked to skewed thyroid hormones in infants
In a new study, researchers have discovered that 3 fairly common pollutants can alter thyroid-related hormones in infants, which can have potential impacts on growth and brain development. Infants with higher exposures to three contaminants – perchlorate, nitrate or thiocyanate – found in water, food and tobacco smoke had increased levels of thyroid stimulating hormone (TSH), a sign that the thyroid gland may be under performing. The latest findings are important because infants with poor thyroid function are at risk for stunted growth and mental impairment. Perchlorate, nitrate and thiocyanate are environmental chemicals already associated with thyroid problems in adults. The three compounds affect thyroid function by blocking iodine uptake by the thyroid gland. Iodine is needed to make thyroid hormone, and most of this trace mineral comes from diet. Because perchlorate, nitrate, and thiocyanate block iodine uptake, they can create an iodine deficiency, which reduces thyroid hormone production. Due to the link between thyroid function and mental development, children with severe dietary iodine deficiency are at risk for mental retardation. Complicated interactions of organs and hormones control thyroid function. Firstly, the brain releases TSH as a signal to the thyroid gland, which is located in the neck, to produce and release thyroid hormone into the blood. There, thyroid hormone circulates throughout the body to regulate development and a host of other essential body functions throughout life. When thyroid hormones levels are low, TSH levels rise to stimulate thyroid hormone production. Hence, doctors consider high TSH levels to be a sign of decreased thyroid function. People are exposed to the three contaminants from various sources.
Perchlorate is used to make rocket fuel, propellants and explosives, including fireworks. It is detected in almost all human urine samples. Widespread exposure occurs through drinking water, food, breast milk and infant formula. Nitrate can be elevated in drinking water, particularly in regions with intense agriculture, high fertiliser use and confined animal feed lots. Thiocyanate is found in tobacco smoke. During this study, the researchers used samples and data gathered through the Study of Estrogen Activity and Development (SEAD). TSH, thyroid hormone, perchlorate, nitrate, thiocyanate and iodide were measured in the urine collected from 92 infants from 0 – 12 months of age. They related the contaminant levels in the urine to those of TSH and thyroid hormone. In addition, the researchers examined whether lower iodine levels affected the associations between the chemicals and the hormones. The results indicated that those infants with higher amounts of any one of the three contaminants also had higher TSH in their urine. The effect of perchlorate, in particular, was most pronounced in infants with low iodide. Paradoxically, the authors also detected that increased exposure to the three contaminants was associated with higher thyroid hormone levels. This was unexpected because high TSH levels usually accompany low thyroid hormone levels. The researchers suggest that thyroid regulation may be different in infants compared to adults, and/or these contaminants may affect other aspects of thyroid and kidney function, in addition to iodine uptake.
Environmental Health News, 13 July 2010 http://www.environmentalhealthnews.org/
Honey as an Antibiotic: Scientists Identify a Secret Ingredient in Honey That Kills Bacteria
Sweet news for those looking for new antibiotics, a new study published recently in the July 2010 edition of the FASEB Journal explains for the first time how honey kills bacteria. Specifically, the research demonstrated that bees make a protein that they add to the honey, called defensin-1, which could one day be used to treat burns and skin infections and to develop new drugs that could combat antibiotic-resistant infections. “We have completely elucidated the molecular basis of the antibacterial activity of a single medical-grade honey, which contributes to the applicability of honey in medicine,” said Sebastian A.J. Zaat, Ph.D., a researcher involved in the work from the Department of Medical Microbiology at the Academic Medical Centre in Amsterdam. “Honey or isolated honey-derived components might be of great value for prevention and treatment of infections caused by antibiotic-resistant bacteria.” During the study, Zaat and colleagues investigated the antibacterial activity of medical-grade honey in test tubes against a panel of antibiotic-resistant, disease-causing bacteria. They developed a method to selectively neutralise the known antibacterial factors in honey and determine their individual antibacterial contributions. Ultimately, researchers isolated the defensin-1 protein, which is part of the honey bee immune system and is added by bees to honey. After analysis, the researchers concluded that the vast majority of honey’s antibacterial properties come from that protein. This information also sheds light on the inner workings of honey bee immune systems, which may one day help breeders create healthier and heartier honey bees. “We’ve known for millennia that honey can be good for what ails us, but we haven’t known how it works,” said Gerald Weissmann, M.D., Editor-in-Chief of the FASEB Journal, “Now that we’ve extracted a potent antibacterial ingredient from honey, we can make it still more effective and take the sting out of bacterial infections.”
Science Daily, 30 June 2010 http://www.sciencedaily.com
Traffic air pollution near school associated with onset of asthma
According to the findings from new research, the risk for developing asthma increases in children who are exposed to traffic-related air pollution at school. Children who breathe traffic-related air pollution at school are more likely to develop asthma, even after taking into account levels of air pollution at their homes, report researchers recently in the journal Environmental Health Perspectives. The results from the latest study add to the small, but growing, body of research implicating traffic-related air pollution in the development of asthma. In addition, this study suggests that places away from home where children spend time play an important role in their health. In the United States, asthma is one of the most common childhood diseases. Rates among school-aged children continue to rise, leading to increased absences, more health care and lower quality of life. Asthma is a lung disease with symptoms that include wheezing, coughing, shortness of breath and difficulty breathing. Public schools in urban areas of the United States are frequently located near streets with heavy traffic flow. The close proximity to freeways and busy roads may result in increased exposure to traffic-related air pollution. Prior studies show that children attending these schools have higher rates of asthma. However, it is unclear whether the traffic-related pollution would contribute to the onset of asthma in children without the respiratory disease. In order to find out, the researchers from the University of Southern California followed almost 2,500 asthma-free children beginning when they were younger than 6 years old and just entering either kindergarten or first grade.
The children were from 45 different schools in 13 communities in Southern California. Outdoor traffic-related air pollutants – including particulate pollutants, nitrogen dioxide (NO2) and ozone – were measured continuously at central neighbourhood locations during the three-year study. The child’s exposure to traffic-related pollution at home and school were estimated. Family health history, housing, smoking and other personal information was gathered from questionnaires given at the study’s start and once a year after that. Children with asthma or wheezing at the start of the study were not included in this analysis. The results demonstrated that during the course of the study, 120 children developed asthma. Interestingly, the risk of developing asthma increased by about the same amount – about 50 percent – for exposures at school and at home, even though less time is spent at school. Weather may play a bigger role than other studies have shown. The results were strongest when weather was combined with traffic volume and closeness to busy streets. Exposure at school may be higher because of deeper, more frequent breathing during exercise and recess. Furthermore, schools may have higher pollution levels in mornings – when winter-time air inversions may keep pollution at ground level – and evenings when buses and cars congregate to drop off and pick up kids.
Environmental Health News, 7 July 2010 http://www.environmentalhealthnews.org/