REACH | 拟新增附件17甲醛（车辆内部）浓度的限制条款

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来源:ec.europa.eu | 作者:沐睿环境-莉哥 | 发布时间: 2022-05-07 | 1302 次浏览 | 分享到:

5月2日欧盟委员会向世贸组织（WTO）提交了通报号G/TBT/N/EU/888，草案将对法规(EC) No 1907/2006附件XVII进行修订，增加以下限制:生产中故意添加甲醛或者甲醛释放物质的物品，在限制附录规定的检测条件下，其甲醛释放浓度超过0.062 mg/m3的，投放市场的，其他物品为0.08 mg/m3。道路车辆也是如此，车辆内部的甲醛浓度超过0.062mg/m3。对于道路车辆，这一限制应在其生效后48个月适用;对于其范围内的所有其他物品，这一限制应在其生效后36个月适用，并规定了相关的检测方法。该通报公众咨询周期为60天，公众咨询截止日期为2022年7月1日，并拟于欧盟官方公报发布后第20天生效。

法规(EC)1907/2006附件XVII修订如下:

(1)增加了以下条目:

“xx. 甲醛

CAS:50-00-0

EC:200-001-8

以及甲醛释放物质

‘xx. Formaldehyde
CAS No 50-00-0
EC No 200-001-8
and formaldehyde releasing substances

1. 不得投放市场的物品，(自本修订条例生效之日起36个月)在生产过程中故意添加甲醛或者甲醛释放物，在附录[X]规定的试验条件下，其释放的甲醛浓度超过:

(a) 木制品和家具为0.062毫克/立方米;

(b) 除木制物品和家具外，其他物品的剂量为0.08毫克/立方米。

第一款不适用于:

(a) 仅在合理可预见的条件下供户外使用的物品;

(b) 专门用于工业或专业用途的物品，除非其释放的甲醛导致公众在可预见的使用条件下接触到这些物品;

(d) 属于欧洲议会和理事会法规(EU) 528/2012 *范围内的生物杀灭产品的物品;

(e) 法规(EU) 2017/745范围内的装置;

(f) 法规(EU) 2016/425范围内的个人防护设备;

(g) 拟与规例(EC)第1935/2004号范围内的食物直接或间接接触的物品;

(h) 二手物品。

2. 不得在道路车辆上以(本修订规例生效之日起48个月)在生产过程中故意添加甲醛或甲醛释放物质的，在附录[X]规定的试验条件下，该车辆内部甲醛浓度超过0.062 mg/m3。

第一款不适用于:

(a) 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导致一般公众在可预见的使用条件下接触这些车辆;

(b) 二手汽车。

1. Shall not be placed on the market in articles, after [OP, please insert the date: 36 months after the date of entry into force of this amending Regulation] where formaldehyde or formaldehyde releasing substances have been intentionally added during their production, if, under the test conditions specified in Appendix [X], the concentration of formaldehyde released from those articles exceeds:
(a) 0,062 mg/m3 for wood-based articles and furniture;
(b) 0,08 mg/m3 for articles other than wood-based articles and furniture.
The first subparagraph shall not apply to:
(a) articles that are only for outdoor use under reasonably foreseeable conditions;
(b) articles exclusively for industrial or professional use unless formaldehyde released from them leads to exposure of the general public under foreseeable conditions of use;
(c) articles within the scope of entry 72 of this Annex;
(d) articles that are biocidal products within the scope of Regulation (EU) 528/2012 of the European Parliament and of the Council*;
(e) devices within the scope of Regulation (EU) 2017/745;
(f) personal protective equipment within the scope of Regulation (EU) 2016/425;
(g) articles intended to come into contact directly or indirectly with food within the scope of Regulation (EC) No 1935/2004;
(h) second-hand articles.
2. Shall not be placed on the market in road vehicles after [OP, please insert the date: 48 months after the date of entry into force of this amending Regulation] where formaldehyde or formaldehyde releasing substances have been intentionally added during their production, if, under the test conditions specified in Appendix [X], the concentration of formaldehyde in the interior of those vehicles exceeds 0,062 mg/m3.
The first subparagraph shall not apply to:
(a) road vehicles exclusively for industrial or professional use unless the concentration of formaldehyde in the interior of those vehicles leads to exposure of the general public under foreseeable conditions of use;
(b) second-hand vehicles.’

* 欧洲议会和理事会2012年5月22日关于生物杀虫剂产品的市场供应和使用的法规(EU) No 528/2012 (OJ L 167, 27.6.2012, p. 1) ';

* Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).’;

(2)增加附件[X]:

1. 进项【xx】第一项第一条所述物品释放到室内空气中的甲醛的测定

1.1参考条件

第一项第一条所述物品释放的甲醛，应在下列参考条件下，在试验室内的空气中测量:

(a)试验室内温度应为(23±0,5)⁰C;

(b)试验室内相对湿度为(45±3)%;

(c)加载系数，表示试件总表面积与试验箱容积之比，为(1±0.02)m2/m3;在合理可预见的使用条件下，如果该荷载系数明显不现实，则可使用EN 165161第4.2.2节规定的荷载系数;

(d)试验室内空气交换速率为(1±0,05)h-1;

(e)适当的分析程序，以测量试验室内的甲醛浓度应使用;

(f)对应使用试样取样的适当方法;

(g)测试室内空气中的甲醛浓度应在整个测试过程中每天至少测量两次，两次连续采样之间的时间间隔至少为3小时;应重复测量，直到有足够的数据来确定稳态浓度;

(h)试验的持续时间须足以确定稳定状态浓度，且不得超过28天;

(i)在应使用试验室内测定的甲醛稳态浓度，以验证是否符合进入项[xx]第一款第一款规定的物品的甲醛释放限值。

第xx项第一项第一条所述物品释放的甲醛，也可以在比本条第一款所列条件更严格的参考条件下，在试验室内空气中测定;较高的温度和/或较高的相对湿度和/或较高的负载系数和/或较低的空气交换率应被认为是更严格的条件。（译文为软件翻译，如有异议以英文为准）

1. Measurement of formaldehyde released to indoor air from articles referred 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 test chamber 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) %;
EN 3 EN
(c) the loading factor, expressed as the ratio of the total surface area of 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 realistic under reasonably foreseeable conditions of use, loading factors in accordance 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 formaldehyde concentration 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 shall be measured at least twice per day throughout the test with a time interval between two consecutive samplings of 3 hours at a minimum; the measurement shall be repeated until sufficient data are available to determine the steady state concentration;
(h) the duration of the test shall be sufficiently long to allow the determination of the steady state concentration and shall not exceed 28 days;
(i) the steady state concentration of formaldehyde measured in the test chamber shall be used to verify the compliance with the limit value of formaldehyde released from articles referred to in paragraph 1, first subparagraph, of entry [xx].
Formaldehyde released from articles referred to in paragraph 1, first subparagraph, of entry xx] may also be measured in the air of a test chamber under the reference conditions that are more stringent than the ones listed in the first paragraph of this point; higher temperature and/or higher relative humidity and/or higher loading factor and/or lower air exchange rate shall be considered to be more stringent conditions.

2017年10月27日，世界卫生组织国际癌症研究机构公布的致癌物清单中，将甲醛放在一类致癌物列表中。2019年7月23日，甲醛被列入有毒有害水污染物名录（第一批）。

用途：是一种重要的有机原料，可作为酚醛树脂、脲醛树脂、维纶、乌洛托品、季戊四醇、染料、农药和消毒剂等的原料。易溶于水和乙醇。水溶液的浓度最高可达55%，一般是35%-40%，通常为37%，称做甲醛水，俗称福尔马林。

健康危害：本品对粘膜、上呼吸道、眼睛和皮肤有强烈刺激性。接触其蒸气，引起结膜炎、角膜炎、鼻炎、支气管炎；重者发生喉痉挛、声门水肿和肺炎等。对皮肤有原发性刺激和致敏作用；浓溶液可引起皮肤凝固性坏死。口服灼伤口腔和消化道，可致死。
慢性影响：长期低浓度接触甲醛蒸气，可出现头痛、头晕、乏力、两侧不对称感觉障碍和排汗过盛以及视力障碍。本品能抑制汗腺分泌，长期接触可致皮肤干燥皲裂。
甲醛是一种具强还原性的原生质毒素，进入人体器官后，能与蛋白质中的氨基结合生成所谓甲酰化蛋白而残留在体内，其反应速度受pH值温度的显著影响。进入人体的甲醛亦可能转化成甲酸强烈地刺激粘膜，并逐渐排出体外。