REACH法規附件XVII 新增兒童接觸產(chǎn)品中鉛含量的要求

REACH法規,附件XVII,新增,兒童接觸產(chǎn)品,鉛含量
REACH法規附件XVII條款63,鉛限量的要求于2015年4月22日由歐盟委員會(huì )法規(EU) 2015/628正式修訂,并于次日在歐盟官方公報(Official Journal of the EU)中發(fā)布。
此次,針對條款63的修訂,要求兒童可入口及可接觸產(chǎn)品的鉛含量不得高于0.05%,對鉛釋放量低于0.05 μg/cm2 / hour或0.05 μg/g/h的產(chǎn)品可以豁免,限量將于2016年6月1日開(kāi)始生效。詳細條款請參見(jiàn)下文。
時(shí)間表:
Time Line
  • 2012年12月21日,瑞典遞交Annex XV卷宗
  • 該限制提案,由風(fēng)險評估委員會(huì )(RAC, Committee for Risk Assessment)于2013年12月10日正式審核通過(guò)。>> 詳情
  • 2013年12月11日-2014年2月14日,SEAC意見(jiàn)接受公眾咨詢(xún)
  • 2014年12月3日,歐盟委員會(huì ),REACH委員會(huì )會(huì )議通過(guò)該限制條款 >>詳情
  • 2014年9月25日,歐盟委員會(huì )通知WTO該項委員會(huì )條例草案>>詳情
  • 2015年4月22日,委員會(huì )法規(EU) 2015/628由歐盟委員會(huì )主席Jean Claude-Juncker 正式簽署
  • 2015年4月23日,歐盟官方公報發(fā)布(EU) 2015/628>>官方公報

具體修訂內容如下:
In Annex XVII to Regulation (EC) No 1907/2006, column 2 of entry 63 is amended as follows:
REACH法規(Regulation (EC) No 1907/2006)附件XVII第63條第2列修訂情況如下:
(1) paragraph 6 is replaced by the following:
(1) 第6段替換如下:
‘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,委員會(huì )應該就1-5段內容結合最新的科學(xué)信息對其替代品以及第1段中的限值進(jìn)行重新評估,如果有必要,根據相關(guān)信息修訂本條款。
(2) the following paragraphs 7 to 10 are added:
(2) 新增以下7-10條:
‘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.在正常合理可預計的條件下,能被放入兒童口中的產(chǎn)品以及可接觸部件中的鉛含量(以鉛計)大于等于0.05%的,不得在投放市場(chǎng)或在供應給公眾的產(chǎn)品中使用。
該限量不適用于:產(chǎn)品以及其任何可接觸部件的鉛釋放量低于0.05 μg/cm2 / hour(或0.05 μg/g/h)的,不管是否帶涂層;另外要求帶涂層的物品,至少保證在正常使用情況下,兩年內其鉛的釋放量不得超過(guò)以上限量。
物品及其可接觸部件可被兒童放入口中的判別依據為:產(chǎn)品某一維度的尺寸小于5cm,或者其某一可分離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.作為條款7的豁免,以下產(chǎn)品不受管控
(a)第1段中已經(jīng)管控的珠寶類(lèi)產(chǎn)品;
(b)理事會(huì )指令 69/493/EEC 的附件I(1, 2, 3 和 4類(lèi))中定義的水晶玻璃;
(c)非合成或再生的貴重寶石和裝飾性寶石(CN 碼7103,歸于條例(EEC)No 2658/87中),除非其用鉛或鉛化合物或者經(jīng)含有此類(lèi)物質(zhì)的混合物處理;
(d)琺瑯,被定義為至少在500℃的溫度下礦物融化、玻璃化或燒結而得到的玻璃化混合物;
(e)包括掛鎖在內的鑰匙和鎖;
(f)樂(lè )器;
(g)物品或者物品的某部分由黃銅組成,其黃銅部件的鉛濃度(以鉛計)不得超過(guò)0.5%(質(zhì)量分數);
(h)書(shū)寫(xiě)工具的尖端;
(i)宗教產(chǎn)品;
(j)便攜式鋅-碳化學(xué)電池以及紐扣電池;
(k)以下范圍內的物品:
(i)Directive 94/62/EC 歐盟包裝指令
(ii)Regulation (EC) No 1935/2004 歐盟食品接觸材料法規
(iii)Directive 2009/48/EC歐盟玩具安全指令
(iv)Directive 2011/65/EU 歐盟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,委員會(huì )應根據最新科技信息,對第7段和第8段(e), (f), (i) 和 (j)條款的替代物的適用性、以及第7段中提到的鉛遷移量,以及涂層的完整性要求進(jìn)行重估,若合適,則應據此進(jìn)行修訂。
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.首次投放市場(chǎng)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).’


(EU) 2015/628

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