如果我必须采用某种工艺来提取这种物质，我是否必须注册自然界中存在的物质？

如果我必须采用某种工艺来提取这种物质，我是否必须注册自然界中存在的物质？

Do I have to register a substance occurring in nature if I have to apply a process to extract this substance?

根据 REACH 法规第 2(7)(b) 条和附件五第 8 点，自然界中存在的物质无需注册，只要它们未经化学改性、未根据 67/548/EEC 指令归类为危险品，也不属于 PBT 或 vPvB 等高度关注物质。如果采用某种工艺提取此类物质，则必须验证所采用的工艺是否为 REACH 法规第 3(39) 条所列工艺之一。如果是，该物质仍可视为自然界中存在的物质，无需注册。REACH 法规第 3(39) 条中提到的工艺包括手动、机械或重力工艺、溶于水、浮选、用水提取、蒸汽蒸馏、仅加热除水以及从空气中提取。请注意，用水以外的溶剂提取（例如己烷或乙醇）不属于 REACH 法规第 3(39) 条的范围。用这些溶剂提取的物质不符合自然界中存在的物质的条件，不能根据 REACH 附件五第 8 点获得注册豁免。例如，薰衣草油是通过蒸汽蒸馏法从某些薰衣草品种（自然界中存在的）的花朵中提取的。随后油和水的自然分离使得薰衣草油很容易分离。由于 REACH 第 3 条第 39 款提到了这种提取工艺，因此薰衣草油可以被视为自然界中存在的物质。相反，例如，用水和乙醇（1:10）的溶剂混合物从菊花的花朵和叶子（自然界中存在的）中提取的菊花油不能被视为自然界中存在的物质。一般而言，重要的是要记住，制造商有责任评估所采用的工艺，并确定 REACH 第 3 条第 39 款的定义是否适用。

Substances occurring in nature are exempted from the duty to register in accordance with Article 2(7)(b) and Annex V, point 8 of REACH, as long as they are not chemically modified, not classified as dangerous in accordance with Directive 67/548/EEC, nor substances of very high concern, such as PBT or vPvB substances. If a process is applied to extract such a substance, it has to be verified whether the process applied is one of those listed in Article 3(39) of the REACH Regulation. If this is the case, the substance still qualifies as substance that occurs in nature that does not have to be registered. The processes mentioned in Article 3(39) of REACH are manual, mechanical or gravitational processes, dissolution in water, flotation, extraction with water, steam distillation, heating solely to remove water and extraction from air. Please note that extraction with solvents other than water, like e.g. hexane or ethanol, are not covered by Article 3(39) of REACH. Substances which are extracted with these solvents do not qualify as a substance that occurs in nature and cannot be exempted from registration on the basis of Annex V, point 8 of REACH. Lavender oil, for example, is extracted from flowers of certain species of lavender (which occur in nature) by means of steam distillation. The subsequent spontaneous separation of oil and water allows an easy isolation of the lavender oil. As this extraction process is mentioned in Article 3(39) of REACH, the lavender oil can be regarded as a substance that occurs in nature. On the contrary, chrysanthemum oil, for example, which is extracted from chrysanthemum blossoms and leaves (which occur in nature) with a solvent mixture of water and ethanol (1:10), cannot be regarded as a substance that occurs in nature. In general, it is important to remember that it is up to the manufacturer to assess the process applied and to determine if the definition of Article 3(39) of REACH is applicable or not.