ENTRY 8

Substances which occur in nature other than those listed under paragraph 7, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Regulation (EC) No 1272/200810 or unless they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or unless they were identified in accordance with Article 59(1) at least two years previously as substances giving rise to an equivalent level of concern as set out in Article 57(f).

This exemption includes 'substances occurring in nature' if they are not chemically modified, and which are not listed in paragraph 7, unless they meet the criteria for classification as dangerous (hazardous) according to Regulation (EC) No 1272/2008. 

To determine if a substance fulfils the requirements for this exemption, the following points should be considered: 

The substances must meet the definition of a 'substance which occurs in nature' as defined in Article 3(39)11; and 

The substance must not be chemically modified as defined in Article 3(40). Chemical modification includes but is not limited to hydrogenation, neutralization, oxidation, esterification, and amidation; and 

The substances must not meet the criteria for classification as dangerous (hazardous) according to Regulation (EC) No 1272/2008. A naturally occurring substance is not covered by this exemption if it is either on Annex VI of Regulation (EC) No 1272/2008 or the manufacturer or importer of the substance has determined that it meets the criteria set out in Parts 2 to 5 of Annex I of Regulation (EC) No 1272/2008. In addition, a naturally occurring substances meeting the criteria for PBTs and or vPvBs in Annex XIII is also not exempted. A substance giving rise to an equivalent level of concern according to Article 57(f) and included on the candidate list (according to Article 59(1)) at least two years previously, is no longer subject to an exemption under this point and should be registered12. 

In all cases, the burden of proof rests with the manufacturer/importer that wishes to use this exemption for his substance. An absence of information on the properties of a  substance cannot be equated to the absence of hazardous properties. Many substances that might fall into the 'substances which occur in nature' category have insufficient information available on them to be able to conclude that they are not dangerous. To exempt such substances would undermine the aims of REACH to gather information on substances in order to determine their potential hazards. 

Examples of substances that are not covered by this exemption include but are not limited to, e.g. fermentation products which are isolated by other means as those given in Article 3(39). In these examples, the substances have undergone chemical modification, i.e. solvent extraction (bonemeal), fermentation products (enzymes), or are dangerous and thus not exempt from registration. 

Examples of substances that are covered by this exemption include but are not limited to cotton, wool, with the provision that fulfils the conditions of Articles 3(39) and 3(40) and not meeting the classification criteria to be dangerous (hazardous) according to Regulation (EC) No 1272/2008. 

If the classification of a substance is changed from not meeting the criteria to meeting the criteria for classification due to new information and the substance therefore meets the criteria for classification as dangerous (hazardous) according to Regulation (EC) 1272/2008, the exemption from registration provisions no longer applies and thus the substance needs to be registered. 

10 From 1 December 2010 onwards the reference to Directive 67/548/EEC in entry 8 of Annex V was replaced by Regulation (EC) No 1272/2008. 

11 See entries 7 and 8 for guidance on this definition. 

12 In the latter case if a substance occurring in nature is identified according to Article 57(f) and included in the candidate list it is no longer subject to an exemption under this point from a date two years after its inclusion (on the candidate list) and should be registered by that date. The date of inclusion is indicated in the candidate list on the ECHA web site.