REACH法规附件XVII 新增儿童接触产品中铅含量的要求

技服 2015-05-08 08:42:10 #419

REACH法规附件XVII条款63，铅限量的要求于2015年4月22日由欧盟委员会法规(EU) 2015/628正式修订，并于次日在欧盟官方公报（Official Journal of the EU）中发布。此次，针对条款63的修订，要求儿童可入口及可接触产品的铅含量不得高于0.05%，对铅释放量低于0.05 μg/cm2 / hour或0.05 μg/g/h的产品可以豁免，限量将于2016年6月1日开始生效。详细条款请参见下文。具体修订内容如下：
In Annex XVII to Regulation (EC) No 1907/2006, column 2 of entry 63 is amended as follows:
REACH法规（Regulation (EC) No 1907/2006）附件XVII第63条第2列修订情况如下：
(1) paragraph 6 is replaced by the following:
(1) 第6段替换如下：

‘6.By 9 October 2017, the Commission shall re-evaluate paragraphs 1 to 5 of this entry in the light of new scientific information, including the availability of alternatives and the migration of lead from the articles referred to in paragraph 1 and, if appropriate, modify this entry accordingly.’
2017年10月9日之前，委员会应该就1-5段内容结合最新的科学信息对其替代品以及第1段中的限值进行重新评估，如果有必要，根据相关信息修订本条款。

(2) the following paragraphs 7 to 10 are added:
(2) 新增以下7-10条：

‘7.Shall not be placed on the market or used in articles supplied to the general public, if the concentration of lead (expressed as metal) in those articles or accessible parts thereof is equal to or greater than 0,05 % by weight, and those articles or accessible parts thereof may, during normal or reasonably foreseeable conditions of use, be placed in the mouth by children. That limit shall not apply where it can be demonstrated that the rate of lead release from such an article or any such accessible part of an article, whether coated or uncoated, does not exceed 0,05 μg/cm2 per hour (equivalent to 0,05 μg/g/h), and, for coated articles, that the coating is sufficient to ensure that this release rate is not exceeded for a period of at least two years of normal or reasonably foreseeable conditions of use of the article. For the purposes of this paragraph, it is considered that an article or accessible part of an article may be placed in the mouth by children if it is smaller than 5 cm in one dimension or has a detachable or protruding part of that size.
7.在正常合理可预计的条件下，能被放入儿童口中的产品以及可接触部件中的铅含量（以铅计）大于等于0.05%的，不得在投放市场或在供应给公众的产品中使用。
该限量不适用于：产品以及其任何可接触部件的铅释放量低于0.05 μg/cm2 / hour（或0.05 μg/g/h）的，不管是否带涂层；另外要求带涂层的物品，至少保证在正常使用情况下，两年内其铅的释放量不得超过以上限量。
物品及其可接触部件可被儿童放入口中的判别依据为：产品某一维度的尺寸小于5cm，或者其某一可分离部件或突出部位的尺寸小于5cm。
8.By way of derogation, paragraph 7 shall not apply to: (a) jewellery articles covered by paragraph 1; (b) crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to Directive 69/493/EEC; (c) non-synthetic or reconstructed precious and semi-precious stones (CN code 7103 as established by Regulation (EEC) No 2658/87) unless they have been treated with lead or its compounds or mixtures containing these substances; (d) enamels, defined as vitrifiable mixtures resulting from the fusion, vitrification or sintering of mineral melted at a temperature of at least 500 °C; (e) keys and locks, including padlocks; (f) musical instruments; (g) articles and parts of articles comprising brass alloys, if the concentration of lead (expressed as metal) in the brass alloy does not exceed 0,5 % by weight; (h) the tips of writing instruments; (i) religious articles; (j) portable zinc-carbon batteries and button cell batteries; (k) articles within the scope of: (i) Directive 94/62/EC; (ii) Regulation (EC) No 1935/2004; (iii) Directive 2009/48/EC of the European Parliament and of the Council(*); (iv) Directive 2011/65/EU of the European Parliament and of the Council(**)
8.作为条款7的豁免，以下产品不受管控
(a)第1段中已经管控的珠宝类产品；
(b)理事会指令 69/493/EEC 的附件I（1, 2, 3 和 4类）中定义的水晶玻璃；
(c)非合成或再生的贵重宝石和装饰性宝石（CN 码7103，归于条例(EEC)No 2658/87中），除非其用铅或铅化合物或者经含有此类物质的混合物处理；
(d)珐琅，被定义为至少在500℃的温度下矿物融化、玻璃化或烧结而得到的玻璃化混合物；
(e)包括挂锁在内的钥匙和锁；
(f)乐器；
(g)物品或者物品的某部分由黄铜组成，其黄铜部件的铅浓度(以铅计)不得超过0.5%（质量分数）；
(h)书写工具的尖端；
(i)宗教产品；
(j)便携式锌-碳化学电池以及纽扣电池；
(k)以下范围内的物品：
   (i)Directive 94/62/EC 欧盟包装指令
   (ii)Regulation (EC) No 1935/2004 欧盟食品接触材料法规
   (iii)Directive 2009/48/EC欧盟玩具安全指令
   (iv)Directive 2011/65/EU 欧盟RoHS 2.0
9.By 1 July 2019, the Commission shall re-evaluate paragraphs 7 and 8(e), (f), (i) and (j) of this entry in the light of new scientific information, including the availability of alternatives and the migration of lead from the articles referred to in paragraph 7, including the requirement on coating integrity, and, if appropriate, modify this entry accordingly.
9. 在2019年7月1日前，委员会应根据最新科技信息，对第7段和第8段(e), (f), (i) 和 (j)条款的替代物的适用性、以及第7段中提到的铅迁移量，以及涂层的完整性要求进行重估，若合适，则应据此进行修订。
10.By way of derogation paragraph 7 shall not apply to articles placed on the market for the first time before 1 June 2016.
10.首次投放市场日期在2016年6月1日之前的，不受第7段管控。
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(*) Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1).
(**) Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88).’