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2. Regulation of Chemicals

2. Regulation of Chemicals (1) REACH-Related Legislation EC Regulation 1907/2006 Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (OJ 2006 L 396/1) (REACH Regulation) is a work in progress, as it is under review and subject to further amendments every year. Nonylphenol (NP) and nonylphenol ethoxylates (NPE) arguably pose a risk to the environment, specifically to aquatic species living in surface water. For the purpose of textiles and leather processing, the placing on the market and use of NPE are already restricted by Entry 46 of Annex XVII to the REACH Regulation. However, there is the risk of NPE release into surface water when the textiles are being washed. In order to limit this risk, EU Commission Regulation 2016/26 amends Annex XVII to the REACH Regulation by adding Entry 46a to Annex XVII. Pursuant to the addendum, after 3 February 2021, NPE shall not be placed in textile articles entering the market that can reasonably be expected to be washed in water during their normal lifecycle in concentrations equal to, or greater than, 0.01 percent by weight of that textile article or of each part of the textile article. This phasing-out does not apply to recycled textiles or textiles that are produced exclusively from recycled textiles without the use of NPE (para. 2 of Entry 46a). Paragraph 3 of the new entry defines ‘textile article,’ for the purposes of paragraphs 1 and 2, as any unfinished, semi-finished, or finished product that is composed of at least 80 percent textile fibres by weight or any other product that contains a part that is composed of at least 80 percent textile fibres by weight, including products such as clothing, accessories, interior textiles, fibres, yarn, fabrics, and knitted panels. This regulation may affect international trade, since textiles produced in countries outside of the European Union (EU) might not comply with these provisions. Cadmium is a heavy metal that is used for the production of some paints. Entry 23 of Annex XVII to the REACH Regulation already prohibits the use of cadmium and cadmium compounds in paints. Enforcement of such a provision is more difficult for regulatory authorities than administering the placing on the market of these products. EU Commission Regulation 2016/217 amending Annex XVII to the REACH Regulation prohibits the placing on the market of cadmium in paints with codes [3208] and [3209] in a concentration that is equal to, or greater than, 0.01 percent by weight. The amendment also covers the placing on the market of painted articles if the concentration of cadmium is equal to or greater than 0.1 percent by weight of the paint on the painted article. Testing procedures, particularly of tests in vivo, have been proven to be a critical element of the REACH regime. If possible, in vitro tests should be used as a substitution of in vivo test procedures. In the hope of further reducing animal testing, Article 13(2) of the REACH Regulation stipulates that test methods used to generate information on intrinsic properties of substances required by the REACH Regulation are to be regularly reviewed and improved with a view to possibly reducing testing on vertebrate animals and the number of animals involved. EU Commission Regulation 2016/863 amends Annexes VII and VIII of the REACH Regulation in regard to testing procedures for skin corrosion/irritation, serious eye damage/eye irritation, and acute toxicity. Although the placing on the market and the use of asbestos is already prohibited due to its carcinogenic potential, member states can exempt the placing on the market and use of diaphragms containing chrysotile fibres (white asbestos) for existing electrolysis installations. Two electrolysis installations remain in operation, and, for those, EU Commission Regulation 2016/1005, amending Annex XVII to the REACH Regulation, stipulates that the first sub-paragraph of Entry 6 of Annex XVII shall not apply until 1 July 2025 to the use in those installations of such diaphragms or of chrysotile used exclusively in the maintenance of such diaphragms, provided that such use is carried out in compliance with the conditions of a permit set in accordance with EU Directive 2010/75 on Industrial Emissions (Integrated Pollution Prevention and Control). It also introduces reporting duties of downstream users of chrysotile. EU Commission Regulation 2016/1017 also amends Annex XVII to the REACH Regulation, banning in Entry 65 the placing on the market and the use of inorganic ammonium salts in cellulose insulation mixtures or cellulose insulation articles after 14 July 2018, unless the emission of ammonia from those mixtures or articles results in a concentration of less than three parts per million by volume (2.12 milligrams per cubic metre) under the test conditions specified in paragraph 4 in regard to inorganic ammonium salts. The EU Reference Laboratory for Alternatives to Animal Testing has been able to validate alternative chemical/in vitro test methods for skin sensitization. Taking these into account, EU Commission Regulation 2016/1688, amending Annex VII to the REACH Regulation, alters Points 8.3, 8.3.1, and 8.3.2 of Annex VII of the REACH Regulation, establishing a waiving option for the execution of tests and subjecting in vivo tests to more stringent presuppositions. Bisphenol A (BPA) is a substance that is used in thermal paper for receipts. Studies show that BPA carries risks for the female reproductive system, the brain and behaviour, the mammary gland, metabolism, and obesity. In order to further reduce the risk entailed by the use of BPA, Annex XVII to the REACH Regulation is amended by EU Commission Regulation 2016/2235, adding Entry 66 to this annex, stipulating that BPA shall not be placed on the market in thermal paper in a concentration equal to, or greater than, 0.02 percent by weight after 2 January 2020. (2) REACH-Related Jurisprudence In the year 2016, there was no REACH-related jurisprudence to report. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Yearbook of International Environmental Law Oxford University Press

2. Regulation of Chemicals

Hofmann, Ekkehard
Yearbook of International Environmental Law , Volume Advance Article – Dec 28, 2017
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Publisher
Oxford University Press
Copyright
© The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com
ISSN
0965-1721
eISSN
2045-0052
DOI
10.1093/yiel/yvx024
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Abstract

(1) REACH-Related Legislation EC Regulation 1907/2006 Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (OJ 2006 L 396/1) (REACH Regulation) is a work in progress, as it is under review and subject to further amendments every year. Nonylphenol (NP) and nonylphenol ethoxylates (NPE) arguably pose a risk to the environment, specifically to aquatic species living in surface water. For the purpose of textiles and leather processing, the placing on the market and use of NPE are already restricted by Entry 46 of Annex XVII to the REACH Regulation. However, there is the risk of NPE release into surface water when the textiles are being washed. In order to limit this risk, EU Commission Regulation 2016/26 amends Annex XVII to the REACH Regulation by adding Entry 46a to Annex XVII. Pursuant to the addendum, after 3 February 2021, NPE shall not be placed in textile articles entering the market that can reasonably be expected to be washed in water during their normal lifecycle in concentrations equal to, or greater than, 0.01 percent by weight of that textile article or of each part of the textile article. This phasing-out does not apply to recycled textiles or textiles that are produced exclusively from recycled textiles without the use of NPE (para. 2 of Entry 46a). Paragraph 3 of the new entry defines ‘textile article,’ for the purposes of paragraphs 1 and 2, as any unfinished, semi-finished, or finished product that is composed of at least 80 percent textile fibres by weight or any other product that contains a part that is composed of at least 80 percent textile fibres by weight, including products such as clothing, accessories, interior textiles, fibres, yarn, fabrics, and knitted panels. This regulation may affect international trade, since textiles produced in countries outside of the European Union (EU) might not comply with these provisions. Cadmium is a heavy metal that is used for the production of some paints. Entry 23 of Annex XVII to the REACH Regulation already prohibits the use of cadmium and cadmium compounds in paints. Enforcement of such a provision is more difficult for regulatory authorities than administering the placing on the market of these products. EU Commission Regulation 2016/217 amending Annex XVII to the REACH Regulation prohibits the placing on the market of cadmium in paints with codes [3208] and [3209] in a concentration that is equal to, or greater than, 0.01 percent by weight. The amendment also covers the placing on the market of painted articles if the concentration of cadmium is equal to or greater than 0.1 percent by weight of the paint on the painted article. Testing procedures, particularly of tests in vivo, have been proven to be a critical element of the REACH regime. If possible, in vitro tests should be used as a substitution of in vivo test procedures. In the hope of further reducing animal testing, Article 13(2) of the REACH Regulation stipulates that test methods used to generate information on intrinsic properties of substances required by the REACH Regulation are to be regularly reviewed and improved with a view to possibly reducing testing on vertebrate animals and the number of animals involved. EU Commission Regulation 2016/863 amends Annexes VII and VIII of the REACH Regulation in regard to testing procedures for skin corrosion/irritation, serious eye damage/eye irritation, and acute toxicity. Although the placing on the market and the use of asbestos is already prohibited due to its carcinogenic potential, member states can exempt the placing on the market and use of diaphragms containing chrysotile fibres (white asbestos) for existing electrolysis installations. Two electrolysis installations remain in operation, and, for those, EU Commission Regulation 2016/1005, amending Annex XVII to the REACH Regulation, stipulates that the first sub-paragraph of Entry 6 of Annex XVII shall not apply until 1 July 2025 to the use in those installations of such diaphragms or of chrysotile used exclusively in the maintenance of such diaphragms, provided that such use is carried out in compliance with the conditions of a permit set in accordance with EU Directive 2010/75 on Industrial Emissions (Integrated Pollution Prevention and Control). It also introduces reporting duties of downstream users of chrysotile. EU Commission Regulation 2016/1017 also amends Annex XVII to the REACH Regulation, banning in Entry 65 the placing on the market and the use of inorganic ammonium salts in cellulose insulation mixtures or cellulose insulation articles after 14 July 2018, unless the emission of ammonia from those mixtures or articles results in a concentration of less than three parts per million by volume (2.12 milligrams per cubic metre) under the test conditions specified in paragraph 4 in regard to inorganic ammonium salts. The EU Reference Laboratory for Alternatives to Animal Testing has been able to validate alternative chemical/in vitro test methods for skin sensitization. Taking these into account, EU Commission Regulation 2016/1688, amending Annex VII to the REACH Regulation, alters Points 8.3, 8.3.1, and 8.3.2 of Annex VII of the REACH Regulation, establishing a waiving option for the execution of tests and subjecting in vivo tests to more stringent presuppositions. Bisphenol A (BPA) is a substance that is used in thermal paper for receipts. Studies show that BPA carries risks for the female reproductive system, the brain and behaviour, the mammary gland, metabolism, and obesity. In order to further reduce the risk entailed by the use of BPA, Annex XVII to the REACH Regulation is amended by EU Commission Regulation 2016/2235, adding Entry 66 to this annex, stipulating that BPA shall not be placed on the market in thermal paper in a concentration equal to, or greater than, 0.02 percent by weight after 2 January 2020. (2) REACH-Related Jurisprudence In the year 2016, there was no REACH-related jurisprudence to report. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

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Yearbook of International Environmental Law – Oxford University Press

Published: Dec 28, 2017

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