GOTS认证辅导-全球有机标准下关于危害和毒性的规定

2.3.2 Requirements related to hazards and toxicity
2.3.2 关于危害和毒性的规定
….. Inputs which are classified with specific hazard statements (risk phrases) related to health hazards ….
……被列入健康危害相关特定危险说明（警示性质标准词）分类的投入物……
Interpretation:
解释：
Preparations are prohibited if any of the contained substances, which are classified with any hazard statement listed in this Section are intentionally added/present as a functional component at any level. Further a preparation is prohibited if any of the contained substances, which are classified with any hazard statement listed in this Section, is present above the concentration limit, above which the substance needs to be declared in the SDS (prepared according to one of the equivalent norms / directives as listed in Section 2.3.3.). In a given case of doubt about the classifications and applicable concentration limits, the GHS provisions are decisive.
Preparations which knowingly release such substances at normal application or usage conditions are prohibited.
Preparations are also prohibited if there is validation that their designated use leads to any exceeding residue limits in textiles of the parameters listed in Section 2.4.15.
如果本节所列任何危险说明中包含的任何物质被有意添加/作为任何组别的功能性成分，则禁止使用配制品。
此外，如果本节所列任何危险说明中包含的任何物质的浓度超过了安全数据表声明的物质浓度限值（根据第2.3.3节中列出的等效规范/指令之一制备），则禁止使用配制品。若对分类和相关浓度限量值有疑问，则以GHS的规定作为判定标准。
已知在正常使用条件下会释放出这些物质的配制品禁止使用。
如果确认配制品的指定用途导致纺织品中任何超出第2.4.15节中所列参数的残留限量，则禁止使用配制品。
References:
参考材料：
Global Harmonized System (GHS) as published by the United Nations, 3rd revision 2009 (tables containing hazard statements with H-codes as well as corresponding hazard classes and categories are 
provided for in annex 3)
联合国发布的《全球化学品统一分类和标签制度》（GHS）2009年第三次修订版（附件3提供了包含H代码的危险说明以及相应危险类别的表格）
Regulation EC 1272/2008
欧盟第1272/2008号条例
Further relevant Directives for classification and assessment of preparations:
与配制品分类和评估有关的其他指令：
Directive 2006/8/EC
欧盟第2006/8/EC号条例
Classification & Labelling Inventory for substances registered or notified in the EU
欧盟已注册或通告物质的分类及标识目录
Footnotes: …
脚注：
1) Performing new animal tests to determine unknown LD50 values in the course of the GOTS assessment procedure for inputs (refer to Section 2.3.3) is prohibited. Instead, alternative methods (e.g. Acute Toxicity Estimates (ATE); 
conclusions on analogy from similar products; validated structure-activity relationships; calculation from available data of substances contained; expert judgment; in vitro tests) shall be used to determine unknown values.
GOTS投入物评估程序（参照第2.3.3节）禁止用新的动物试验确定未知的LD50值。取而代之的是替代方法（如急性毒性评估（ATE）；类似产品的类比结论；经验证的结构活动关系；根据所含物质的现有数据进行计算；专家判断；体外试验）用于确定未知值。
3) Performing new fish and daphnia tests to determine unknown LC50 / EC50 values in the course of the GOTS assessment procedure for inputs is prohibited. Instead, alternative methods such as Acute Toxicity Estimates (ATE); 
validated structure-activity relationships; conclusion on analogy from similar products; calculation from available data of substances contained; fish egg test (embryo toxicity test (FET)); in vitro test; IC50 algae; OECD 201 [72hr] shall be used to determine unknown values.
GOTS投入物评估程序禁止采用新的鱼类和水溞试验确定未知的LC50/EC50值。取而代之的是替代方法（如急性毒性评估（ATE）；经验证的结构活动关系；类似产品的类比结论；根据所含物质的现有数据进行计算；鱼卵试验（胚胎毒性试验）；体外试验；IC50藻类；OECD 201【72小时】）用于确定未知值。
脚注1）：“GOTS投入物评估程序（参照第2.3.3节）禁止用新的动物试验确定未知的LD50值。”……
and 及脚注3）：……“GOTS投入物评估程序禁止采用新的鱼类和溞试验未知的LC50/ EC50值。”……