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Methods and Tools for Assessing Nanomaterials and Uses and Regulation of Nanosilver in Europe
Published in Huiliang Cao, Silver Nanoparticles for Antibacterial Devices, 2017
Steffen Foss Hansen, Aiga Mackevica
In the second step of GreenScreen, benchmarks are determined by analysing specific combinations of hazard classifications generated in step 1 and a final Benchmark score is obtained. The Benchmarks were developed to reflect hazard concerns that have been established by governments nationally and internationally and the Benchmark 1 criteria are, for instance, aligned with the definition of a substance of very high concern (SVHC) under REACH. If the data are insufficient, a Benchmark cannot be assigned and only certain numbers and types of data gaps are allowed for each Benchmark level. In step 3 of GreenScreen, all the classification of hazards and the application of benchmarks come together, aiming at making an informed decision about how to address the chemical of concern. The final decision could aim at changing the product design and development, chemical and material procurement, risk management, workplace safety and so on.
Evaluation of Specific Classes of Chemical
Published in David Woolley, Adam Woolley, Practical Toxicology, 2017
REACH stands for Registration, Evaluation, Authorisation and restriction of Chemicals. Producers and importers of chemicals in the European Union in quantities of more than 1 tonne/year are required to produce information that includes a technical dossier that assesses the risks due to use and managing them. For chemicals produced at 10 tonnes/year or more, and for chemicals of concern (CMRs, PBTs, and vPvBs), a chemical safety report is also needed. Evaluation of the submitted documentation is aimed at assessing its completeness as a dossier and on the need for further testing. Where a risk to health or the environment is suspected, action may be taken under authorization or restriction procedures. For instance, substances of very high concern (CMRs, PBTs, or vPvBs) may require authorization. Regulation of substances will extend to the pure chemicals and to their use in products. Restrictions on use may be put in place, and it is possible that a substance may be banned completely and/or that substitution will be required. The caveat on substitution should be considered here again; substitution of a known set of risks for a supposedly safe but novel and unknown chemical does not necessarily increase consumer safety.
Mineral oil in food, cosmetic products, and in products regulated by other legislations
Published in Critical Reviews in Toxicology, 2019
Ralph Pirow, Annegret Blume, Nicole Hellwig, Matthias Herzler, Bettina Huhse, Christoph Hutzler, Karla Pfaff, Hermann-Josef Thierse, Tewes Tralau, Bärbel Vieth, Andreas Luch
In 2006, as a follow-up to the 2002 Johannesburg sustainability summit, the policy goal “to achieve, by 2020, that chemicals are used and produced in ways that lead to the minimization of significant adverse effects on human health and the environment, using transparent science-based risk assessment procedures and science-based risk management procedures, taking into account the precautionary approach” was expressed at UN level in the form of the Strategic Approach to International Chemicals Management (SAICM, cf. www.saicm.org, UN (2003)). This has been translated under REACH into the concept of so-called “Substances of Very High Concern” (SVHCs). SVHCs are officially identified and regulated under REACH Title VII (authorization) with the aim “[…] to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable” (REACH Art. 55).
Oligomers of styrene are not endocrine disruptors
Published in Critical Reviews in Toxicology, 2018
Heinz-Peter Gelbke, Marcy Banton, Christian Block, Gordon Dawkins, Edgar Leibold, Mark Pemberton, Atsunobu Sakoda, Atsushi Yasukawa
The former Environmental Agency (EA) of Japan (from which the Ministry of the Environment Japan was formed in 2001), published in 1998 its “Strategic Programs on Environmental Endocrine Disruptors (SPEED’98)”. It originally listed 67 “chemicals suspected of having endocrine disrupting effects” and among these were Di and Tri. This priority list was revised in 2000 and Di and Tri were deleted because their estimated risks were low (https://www.env.go.jp/en/chemi/ed/approach/2002.html). In Europe, Di and Tri had been in the original list of endocrine disruptors (EDs) published by the European Commission (BKH 2000), but the entry was deleted in 2002. Deletion was not based on an evaluation of the database or risk assessment considerations, but according to Annex 10 because the entry did not refer to specific chemical entities but to a “group name” (BKH 2002). Although the focus on Di and Tri may have been diverted within the EU, the discussion on how to identify and regulate chemicals with potential endocrine effects is continuing and gaining momentum with EDs being regarded as substances of very high concern (SVHC) under the chemical’s regulation REACH, the use of which may subsequently be subject to authorization. There are also literature references to Di and Tri, but often the information given is incomplete and focuses on publications with an indication for endocrine activity. An example is the review of Muncke (2009) who only cited two studies, both with positive results. Since PS packaging will likely play a significant role in reducing global food and product waste for the foreseeable future it is timely and prudent to review the total database dealing with endocrine effects of Di and Tri. This review complements two publications of Gelbke et al. (2015) assessing the endocrine activity of styrene and of Gelbke et al. (2018) with a risk assessment of styrene oligomers potentially migrating into food from PS food containers. This review concentrates on human health and does not address environmental effects focusing on the available in silico, in vitro and in vivo screening data together with studies in experimental animals for potential (anti)estrogenic, (anti)androgenic and thyroidal activity.
The effects of bisphenols on the cardiovascular system
Published in Critical Reviews in Toxicology, 2022
Patrícia Dias, Václav Tvrdý, Eduard Jirkovský, Marija Sollner Dolenc, Lucija Peterlin Mašič, Přemysl Mladěnka
The best-known bisphenol, bisphenol A (BPA), has been used as a component in plastic for more than a century (Lind and Lind 2011). Concerns about the risks of BPA on human health have been associated with its potential endocrine-disruptor activity and began in the early 1930s when the first animal in vivo studies took place (Dodds and Lawson 1936). Since that time, more intense research, which culminated within the last two decades, has been carried out. The research resulted in legislative changes concerning the use of BPA in consumer products such as baby bottles, in which it was prohibited in 2011 in the EU (Commission Directive 2011/8/EU of 28 January 2011 amending Directive 2002/72/EC; Sartain and Hunt 2016). In the EU, the use of BPA in thermal paper has been limited since 2016, and a total ban came into force in 2020. Since March 2018, products containing BPA must be classified and labelled as toxic for reproduction (Hercog et al. 2019). BPA is currently classified as a category 1B reproductive toxicant under the EU CLP regulation (Commission Regulation (EU) 2016/1179 of 19 July 2016, Regulation (EC) No 1272/2008 of the European Parliament and of the Council). EU law regulates BPA in plastic materials and articles intended to come into contact with food (Commission Regulation (EU) No 10/2011 of 14 January 2011), and BPA has been banned from infant feeding bottles across Europe since 2011 (Commission Directive 2011/8/EU of 28 January 2011). Additional measures have been taken in several countries. For example, France has banned BPA in all food contact materials (LOI no 2012-1442 du 24 décembre 2012). Other countries such as Belgium, Denmark and Sweden, banned it in those materials intended for children under 3 years of age. BPA was added to the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) annexe XVII restricted substances list on 2016 (Commission Regulation (EU) 2016/2235 of 12 December 2016). This new entry restricted BPA's use in thermal paper and specified that the concentration of BPA must not exceed 0.02% by weight after January 2020 (ECHA 2018). In June 2017, the European Chemicals Agency (ECHA) classified BPA as a substance of very high concern (SVHC) due to its alleged endocrine disrupting effects on human health and the environment (ECHA 2017). In October 2019, ECHA prioritised BPA for toughest EU restrictions by proposing that its use should be subject to prior authorisation. The European Food Safety Authority (EFSA) re-evaluated the risks of BPA in food and proposed in December 2021 to significantly reduce the tolerable daily intake compared to its previous assessment from 2015 (from 4 µg/kg/d to 0.04 ng/kg/d) due to the immunotoxic properties of BPA (EFSA 2021). EFSA’s conclusions on BPA are outlined in a draft scientific opinion that is open for public consultation until 22 February 2022. In the USA, the FDA amended its regulations in July 2012 and 2013, respectively, to prohibit the use of polycarbonate resins containing BPA in baby bottles and sippy cups, and the use of epoxy resins containing BPA as a coating in infant formula packaging.