TY - JOUR
AU - Nazari-Shafti, S Sara M
AB - (1) REACH-related Legislation EC Regulation 1907/2006 Concerning the Regulation, Evaluation, and Authorisation of Chemicals (REACH Regulation) is a work in progress, being under review and subject to further amendment every year. These amendments are presented below. EU Commission Regulation 2020/171 (Non-legislative Act) amends Annex XIV to the REACH Regulation. The following new substances meet the criteria for classification as toxic for reproduction, and/or are (very) persistant and/or (very) bioaccumulative, and are therefore included in Annex XIV to REACH Regulation: 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear, and dihexyl phthalate and the substance group 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0,3 percent of dihexyl phthalate, trixylyl phosphate, sodium perborate, perboric acid, sodium salt and sodium peroxometaborate (category 1B, pursuant to Regulation (EC) No 1272/2008 and Article 57(c) of REACH-Regulation), 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6- dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] (covering any of the individual stereoisomers of [1] and [2] or any combination thereof), 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328); 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327); 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) and 2- benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) (pursuant to Annex XIII to Annex XIII to the REACH Regulation and Article 57(d) and/or (e) of the REACH Regulation). Furthermore, the wording of the notes to the table of Annex XIV to the REACH Regulation was revised in order to ensure consistency of the terminology in regard to articles and complex products in light of the judgment of the Court of Justice of the European Union (CJEU) in Case C-106/14.  EU Commission Regulation 2020/507 (Non-legislative Act) amends Article 41(5) of the REACH Regulation. As the latest assessment indicated that a significant number of the registration dossiers are likely non-compliant, hampering the effective achievement of the objectives of the REACH Regulation, the minimum percentage of registration dossiers to be checked for compliance on all elements listed in Article 41(1) increased from 5 percent to 20 percent. The latter percentage is to be achieved by 31 December 2023 for registrations in tonnage bands of 100 tonnes or more per year and by 31 December 2027 for registrations in tonnage bands of less than 100 tonnes per year, submitted by the 2018 deadline. EU Commission Regulation 2020/878 stipulates a modification of Annex II to REACH Regulation relating to a number of specific requirements for safety data sheets—namely: nanoforms of substances (due to the amendment of Annexes I, III, and VI to XII of REACH Regulation by EU Commission Regulation 2018/1881(2)); classification and labelling of chemicals (due to sixth and seventh revision of the Globally Harmonized System of Classification and Labelling of Chemicals); location of a unique formula identifier (adaption to new requirements of Annex VIII to EC Regulation 1272/2008); and, finally, specific requirements that have been identified as relevant for substances and mixtures with endocrine-disrupting properties to improve the communication through the supply chain for endocrine disruptors under the REACH Regulation in the context of the work on safety data sheets. EU Commission Regulation 2020/1149 amending Annex XVII to the REACH Regulation is in regard to diisocyanates. As a result of ascertainment that the latter substance causes an unacceptable risk to human health by the use or placing on the market, on their own, as a constituent of other substances and in mixtures, a minimum requirement for training is provided to industrial and professional users without prejudice to stricter national obligations in the member states. Moreover, member states have to report to the Commission pursuant to Article 117(1) of the REACH Regulation any established training requirements, the number of reported cases on occupational asthma and occupational respiratory and dermal disease, any national occupational exposure levels, and information on enforcement activities. EU Commission Regulation 2020/2081 amends Annex XVII to the REACH Regulation relating to substances in tattoo inks or permanent make-up for the purpose of unacceptable risk to human health arising from certain substances in mixtures for use for tattooing purposes above specific concentrations limits. Therefore, above a certain practical concentration threshold, several hazardous substances identified for the purposes of EC Regulation 1272/2008, EC Regulation 1223/2009, and Council of Europe Resolution (2008)1 are now banned in tattooing procedures. However, the restrictions are not applied to carcinogenic and mutagenic substances with harmonized classification (due to effect following exposure by inhalation only) nor to gaseous substances other than formaldehyde (as they are not expected to be present in that state in mixtures used for tattooing purposes). EU Commission Regulation 2020/2096 additionally amends Annex XVII to the REACH Regulation in regard to carcinogenic, mutagenic, or reproductive toxicant (CMR) substances, devices covered by EU Regulation 2017/745, persistent organic pollutants, certain liquid substances or mixtures, nonylphenol, and testing methods for azocolourants. Specifically, the references to labelling with R65 (due to repeal of EEC Council Directive 67/548), paragraphs 6 and 7 of entry 3 (as there is no need to propose an amendment of the restriction set out in entry 3), entries 22, 67, and 68 (as there are more severe restrictions for pentachlorophenol and its salts and esters, bis(pentabromophenyl) ether and perfluorooctanoic acid and its salts set out in EU Regulation 2019/1021) as well as CAS and EC numbers for nonylphenol in entry 46 (due to their inclusion had the unintended effect that not all isomers of nonylphenol are now covered by entry 46) are deleted. Furthermore entries 28, 29, and 30 now prohibit the placing on the market and use, for supply to the general public, of substances that are classified as carcinogenic, mutagenic, or reproductive toxicant (CMR), categories 1A or 1B, and listed in Appendices 1–6 to that Annex and of mixtures containing such substances above specified concentrations. The restriction introduced by this regulation in regard to substances classified as CMR Category 1A or 1B by EU Regulation 2020/217 apply from 1 October 2021 due to the fact that delegated EU Regulation 2020/217 applies from the same day on. EU Commission Regulation 2020/2160 amends Annex XIV to the REACH Regulation in regard to the substance group 4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated (covering well-defined substances and substances of unknown or variable composition, complex reaction products or biological materials, polymers, and homologues). The latter substance group is needed to ensure research, development, and production of medical products, medical devices, or accessories to medical devices including in vitro diagnostic medical devices, and for use in such medical devices or accessories in view of their use for the diagnosis, treatment, or prevention of COVID-19 after the sunset date as currently set in Annex XIV to the REACH Regulation. As a measure of public health protection, the amendment clarifies the postponement of the latest application date until eighteen months after the entry into force of the amendment and the sunset date until thirty-six months after its entry into force. (2) REACH-related Jurisprudence There are several REACH-related European court cases to report on from the past year. On 14 July, the General Court (Eighth Chamber) dismissed the action filed by Sasol Germany GmbH et al against European Chemicals Agency (ECHA) for inadmissibility (Case T-640/19). The plaintiffs applied for partial annulment of ECHA Decision ED/71/2019 insofar as it includes 4-tert-butyphenol as a substance of very high concern in the list of substances identified with a view to their eventual inclusion in Annex XIV to the REACH Regulation. In conclusion, the General Court found that the contested act does not constitute a challengeable act producing binding legal effects in respect of the applicants but rather a merely implementing act of the European Commission’s final decision and that there was no interest on behalf of the applicants in bringing proceedings. The (relevant) final identification decision of the substance in this case was taken by the European Commission and had to be implemented by the ECHA (that is, inclusion of the substance in the list) according to Article 59(9) and 59(10) of the REACH Regulation. In particular, the decision of the ECHA did not contain any new aspects that would have justified a judgment in favor of the applicants. On 29 October, the opinion of Advocate-General Tanchev of the Court (First Chamber) in the Case C-389/19 P was delivered. The matter in dispute is the appeal by the European Commission against the decision in favour of Sweden in Case T-837/16. On 7 March 2019, the General Court had upheld the action of Sweden against the European Commission, which was aimed at the annulment of the Commission implementing Decision C (2016) 5644 from 7 September 2016 pursuant to Articles 55–66 of the REACH Regulation authorizing certain uses of lead sulfochromate yellow and of lead chromate molybdate sulfate red (for DCC Maastricht) and furthermore dismissed the action of the Commission to, in case of annulment, uphold the impact of their aforesaid implementing decision until a new assessment pursuant to Articles 55–66 of the REACH Regulation is made. The Commission raises four grounds of appeal. The first ground is based on the incorrect assessment of the standard of proof concerning the lack of suitable alternatives under Article 60(4) of the REACH Regulation. The second ground is based on the failure to consider the Commission’s discretionary powers to set a zero threshold for technical feasibility of alternatives pursuant to Article 60(4) of the REACH Regulation. The third ground is based on the misapplication of Article 60(4) of the REACH Regulation in regard to the partial scope and conditions of authorization in the decision at issue. The fourth ground is based on the incorrect assessment of the request to maintain the effects of the decision at issue. To the advocate-general the first, second, and third grounds of appeal are unfounded, while the fourth ground is well founded. In those circumstances, he takes the view that point 2 of the operative part of the judgment under appeal should be set aside and the Court should maintain the effects of the decision at issue until it is replaced by a new decision. However, the final judgment of the Court is still pending. On 16 December, there were two particular judgments of the General Court to report on. First, the General Court dismissed the action of 3V Sigma v the European Chemicals Agency (ECHA) (Case T-176/19), by which the applicants requested partial annulment of decision A-004-2017 of the ECHA Board of Appeal of 15 January 2019 insofar as it dismissed the applicant’s appeal against the decision of the ECHA of 20 December 2016 requiring that further information be provided about the substance UVASORB HEB and as the deadline for providing that information was set at 22 October 2020. He alleged an error of law and a manifest error of assessment in regard to the need to carry out the Organisation for Economic Co-operation and Development (OECD) TG 308 study and in regard to whether the temperature and test conditions imposed for the OECD TG 308 study were appropriate. The law in dispute was particularly Article 46(1) of the REACH Regulation. In conclusion, the General Court dismissed the action as unfounded, considering the areas of uncertainty created by the results of the quantitative structure-activity relationship models, and in the absence of clear data allowing the formation of transformation or degradation products of UVASORB HEB to be excluded, the ECHA Board of Appeal could, without making a manifest error of assessment or erring in law, take the view that it was necessary to request the applicant to clarify those areas of uncertainty and, consequently, to request additional information from it. Moreover, it shall not be necessary to consider the admissibility of the arguments raised by the applicant in the reply claiming that the ECHA incorrectly interpreted paragraph 41 of the OECD 308 guidelines. Second, on 16 December, the General Court dismissed the action of PlasticsEurope against ECHA (Case T-207/18). The plaintiff had aimed to annul ECHA Decision ED/01/2018 of 3 January 2018, by which the existing entry relating to bisphenol A on the list of identified substances with a view to their eventual inclusion in Annex XIV to the REACH Regulation, in accordance with Article 59 of that regulation, was supplemented to the effect that bisphenol A is also identified as a substance with endocrine-disrupting properties that may have serious effects on the environment, which gives rise to an equivalent level of concern to those of other substances listed in Article 57(a)–(e) of that regulation, within the meaning of Article 57(f) thereof. The applicant claimed that the ECHA manifestly erred in its assessment of the information that, when properly assessed, could not support the ECHA’s conclusion and failed to take into consideration all relevant information related to pending studies, besides erring in its assessment because of failing to establish that (i) there is scientific evidence of probable serious effects due to its endocrine-disrupting properties for the environment and that (ii) such evidence would give rise to an equivalent level of concern to substances listed in points (a)–(e) of Article 57 of the REACH Regulation. Beyond that, the plaintiff argued that the contested decision breaches Articles 59 and 57(f) of the REACH Regulation by identifying BPA as a SVHC on the basis of the criteria referred to in Article 57(f), since Article 57(f) only covers substances that have not yet been identified under Article 57(a)–(e), that the contested decision breaches Article 2(8)(b) of the REACH Regulation since intermediates are exempt from the entire Title VII and are thus outside the scope of Articles 57 and 59 and outside the scope of authorization, and that, finally, it breaches the principle of proportionality since the inclusion of BPA in the candidate list, when it is a non-intermediate, exceeds the limits of what is appropriate and necessary to attain the objective pursued and is not the least onerous measure to which the agency could have had recourse. The General Court found the aforesaid pleas in law to be in parts unfounded and ineffective. © The Author(s) 2021. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)
TI - 2. Regulation of Chemicals
JF - The Yearbook of International Environmental Law Series
DO - 10.1093/yiel/yvab006
DA - 2021-12-06
UR - https://www.deepdyve.com/lp/oxford-university-press/2-regulation-of-chemicals-B0IiLYUkC0
SP - 96
EP - 100
VL - 31
IS - 1
DP - DeepDyve
ER -