该通报案将开展为期60天的公众咨询,公众咨询截止至2022年7月1日,并拟于欧盟官方公报发布后第20天生效。
新增法规内容
根据该修订案,REACH法规附件XVII拟增加一项限制,相关物质及限制条件如下:
第一栏 物质名称、物质组名称或混合物名称 |
第二栏 限制条件 |
---|---|
XX.甲醛 CAS号 50-00-0 EC号 200-001-8 和甲醛释放物质 |
在【本修订条例生效后36个月】之后,生产过程中有意添加甲醛或甲醛释放物质的物品,根据附录【X】列出的检测方法,测得其释放的甲醛浓度超过以下浓度,将不得投放市场: 木制品和家具中:0.062 mg/m3; 木制品和家具以外的物品中:0.08 mg/m3。 第1小段不适用于: 在合理可预见的情况下仅供户外使用的物品; 专门用于工业或专业用途的物品,除非其释放的甲醛在可预见的使用情况下导致公众接触; 本附件第72项范围内的物品; 属于欧洲议会和欧洲理事会2012年05月22日颁布的法规(EU)528/2012范围内的生物杀灭剂的物品; 法规 (EU) 2017/745 范围内的设备; 法规 (EU) 2016/425 范围内的个人防护设备; 法规 (EC) 1935/2004 范围内旨在直接或间接与食品接触的物品; 二手物品。 在【本修订条例生效后48个月】之后,生产过程中有意添加甲醛或甲醛释放物质的道路车辆,根据附录【X】列出的检测方法,测得车内的甲醛浓度超过0.062mg/m3,将不得投放市场。 第1小段不适用于: 专门用于工业或专业用途的道路车辆,除非这些车辆内部的甲醛浓度在可预见的使用情况下导致公众接触; 二手车。 |
新增附录【X】
该修订案,同时拟在REACH法规中新增附录【X】(附录序号暂未定),该附录旨在为提议新增的甲醛限制条款规定适用的检测方法。
Appendix【X】 1. Measurement of formaldehyde released to indoor air from articlesreferred to in paragraph 1, first subparagraph, of entry [xx] 1.1 Reference conditions The formaldehyde released from articles referred to in paragraph 1,first subparagraph of entry [xx] shall be measured in the air of a testchamber under the following reference conditions: (a) the temperature in the test chamber shall be (23 ± 0,5) ⁰C; (b) the relative humidity in the test chamber shall be (45 ± 3) %; (c) the loading factor, expressed as the ratio of the total surface areaof the test piece to the volume of the test chamber, shall be (1 ± 0,02)m2/m3; in cases where such a loading factor is clearly not realisticunder reasonably foreseeable conditions of use, loading factors inaccordance with Section 4.2.2 of EN 165161 may be used; (d) the air exchange rate in the test chamber shall be (1 ± 0,05)h-1; (e) an appropriate analytical procedure, to measure the formaldehydeconcentration in the test chamber shall be used; (f) an appropriate method for sampling of the test pieces shall be used; (g) the formaldehyde concentration in the air of the test chamber shallbe measured at least twice per day throughout the test with a timeinterval between two consecutive samplings of 3 hours at a minimum; themeasurement shall be repeated until sufficient data are available todetermine the steady state concentration; (h) the duration of the test shall be sufficiently long to allow thedetermination of the steady state concentration and shall not exceed 28days; (i) the steady state concentration of formaldehyde measured in the testchamber shall be used to verify the compliance with the limit value offormaldehyde released from articles referred to in paragraph 1, firstsubparagraph, of entry [xx]. Formaldehyde released from articles referred to in paragraph 1, firstsubparagraph, of entry xx] may also be measured in the air of a testchamber under the reference conditions that are more stringent than theones listed in the first paragraph of this point; higher temperatureand/or higher relative humidity and/or higher loading factor and/orlower air exchange rate shall be considered to be more stringentconditions. 1.2. Non-reference conditions If data from a test method using the reference conditions specified inSection 1.1 are not available, data obtained from a test method usingnon-reference conditions may be used, where there is a correlationbetween the results of the test method used and the reference conditionsspecified in Section 1.1. Suppliers of articles may, where applicable, apply existing correlationsto the specific articles and test methods considered, to calculate theformaldehyde releases under the reference conditions specified inSection 1.1 in order to demonstrate compliance with paragraph 1, firstsubparagraph, of entry [xx]. If relevant correlation data are not available, they may be generated ona case-by-case basis. Correlation data may be generated, by performingmeasurements of formaldehyde released from articles or samples ofarticles using a method with non-reference conditions and, in parallel,to measure the formaldehyde released from samples of the same articlesunder the reference conditions specified in Section 1.1. Sufficientrepeat testing shall be conducted to ensure the reliability of suchderived correlation. Where a correlation is evident, it shall only be necessary to undertakethe testing to verify the compliance with the limit value offormaldehyde using the method with non-reference conditions. Parallelmeasurements shall only need to be repeated in case of variations in thecharacteristics of the article, such as material, size, and productionprocess, that may foreseeably affect the release of formaldehyde. 2. Measurement of formaldehyde concentration in the interior ofvehicles referred to in paragraph 2, first subparagraph, of entry [xx] For road vehicles, including trucks and buses, the formaldehydeconcentration shall be measured in accordance with the conditionsspecified in ISO 12219-12, ISO 12219-103 or anequivalent method, and the concentration measured shall be used toverify the compliance with the limit value referred to in paragraph 2,first subparagraph, of entry [xx]. |
1 EN 16516: Construction products – Assessment of release ofdangerous substances – Determination of emissions into indoor air. 2 ISO 12219-1: Interior air of road vehicles – Part 1: Wholevehicle test chamber – Specification and method for the determination ofvolatile organic compounds in cabin interiors. 3 ISO 12219-10: Interior air of road vehicles — Part 10:Whole vehicle test chamber — Specification and methods for thedetermination of volatile organic compounds in cabin interiors — Trucksand buses. |
南京瑞旭提醒
相关企业务必持续关注REACH法规附件XVII限制清单的修订状态,积极开发新材料或使用替代材料,及时调整生产策略,规避相关风险。