ENTRY 9

The following substances obtained from natural sources, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC13 with the exception of those only classified as flammable [R10], as a skin irritant [R38] or as an eye irritant [R36] 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): 

Vegetable fats, vegetable oils, vegetable waxes; animal fats, animal oils, animal waxes; fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts; glycerol. 

This exemption applies only to vegetable fats, vegetable oils, vegetable waxes; animal fats, animal oils, animal waxes; fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts; glycerol. It comprises these substances in so far that they are obtained from natural sources if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC, with the exception of those only classified as flammable [R10], as a skin irritant [R38] or as an eye irritant [R36] or a combination thereof. A substance meeting the criteria for PBTs and 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 registered. 

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 obtained from natural sources' 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. 

This exemption is not limited to ‘naturally occurring substances’ in the sense of the definition of Article 3(39). This means that the specified substances falling under this  exemption can also be obtained through other processes than those described in Article 3(39)14. 

In this exemption ‘obtained from natural sources' means that the original source must be a natural material (plants or animals). 'Not chemically modified' means that the substances covered by this exemption, once obtained from a natural source, are not further chemically modified. 

In particular ‘fatty acids from C6 to C24, and their potassium, sodium, calcium and magnesium salts’ are listed in Annex V(9). They have to be obtained from natural sources to be covered by this exemption, and also they must not be further chemically modified. This means that the chemical structure of the ‘fatty acids from C6 to C24, and their potassium, sodium, calcium and magnesium salts’ substance cannot be changed. 

Note: The exemption does not apply to synthetic materials. 

In general, fats and oils derived from natural sources such as plants or animals are mainly composed of triglycerides (up 97% triglyceride (i.e., triesters of glycerol with fatty acids); up to 3 % diglycerides and up to 1 % monoglycerides). The triglycerides of naturally occurring fats and oils contain saturated and unsaturated fatty acids. 

Note: Hydrogenated fats and hydrogenated oils’ are not considered as vegetable or animal fats and oils but substances, which have undergone a chemical modification of the original fats and oils and are therefore not covered by this entry. 

Groups of substances covered by this exemption are: 

Vegetable fats and vegetable oils

Vegetable fats and oils15 are substances that are generally obtained from the seeds of oilseed plants (rape, flax, sunflower etc), although some other parts of the plants may also yield oils. Vegetable oils and fats are mainly composed of triglycerides, which contain a range of fatty acids of different chain lengths; for example they can be rich in palmitic, oleic or linoleic acid. 

14 The wording ‘substances obtained from natural sources’ is not identical with ‘substances which occur in nature’. In particular, the term ‘substances obtained from natural sources’ is not restricted to the definition of Article 3(39). 

15 The European Commission clarified its interpretation regarding vegetable oils derived from GMOs in a document titled “Status of vegetable oils obtained from Genetically Modified Plants under REACH Regulation (EC) No. 1907/2006” presented at the 4th Meeting of Competent Authorities for REACH and CLP (CARACAL). MSCAs provided comments on this document. 

13 Directive 67/548/EEC will be fully repealed by Regulation (EC) No 1272/2008 with effect from 1 June 2015.  

For example, cocoa butter, contains a high proportion of C16– C18 fatty acids and C18 unsaturated fatty acids, whereas coconut oil contains a high proportion of C6– C16 fatty acids and C18 unsaturated fatty acids. 

Note: This exemption exclusively applies to vegetable fats and vegetable oils but does not cover essential oils. Essential oils are hydrophobic liquids of complex composition, derived from plants, containing volatile organic compounds, such as alcohols, aldehydes, ketones, phenols, esters, ethers and terpenes, in varying proportions. 

Vegetable waxes 

Vegetable waxes are composed of non-glycerolic esters of long chain fatty acids esterified with long chain fatty alcohols, triterpenic alcohols and sterols. An example for a vegetable wax is carnauba wax derived from the leaves of the carnauba palm. 

Animal fats and animal oils 

Animal fats and animal oils can be obtained from the tissue fats of a variety of animals. 

For example, fats such as tallow and lard, mainly composed of triglycerides, contain predominantly C16 and C18 fatty acids, whereas milk fat (butterfat) contains a high proportion of C6– C12 fatty acids. 

Animal oils obtained from fish or other sea creatures tend to have a higher proportion of polyunsaturated fatty acids than other animal fats/oils. The distribution of chain lengths is also different, with a chain length of C16 – C24 being more common. They are also richer in omega-3 fatty acids (e.g. fish oils and whale oil) than other animal fats.

Animal waxes

Animal waxes are composed of nonglycerolic esters of long chain fatty acids esterified with long chain fatty alcohols, triterpenic alcohols and sterols. Examples are beeswax and lanolin from sheep wool. 

Note: This exemption does not apply to synthetic materials such as silicone wax that exhibit similar properties or any synthetic waxes manufactured from by distillation from natural petroleum or completely synthetic waxes. 

Fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts 

Although free fatty acids do occur in nature, they are typically present only in very small quantities in oils of fats. They are generally present in a chemically bonded form as triglycerides in natural sources, hence oils, fats and waxes as a combinations of various fatty acids with varying proportions depending on the origin of the fats, oils or waxes. In higher plants and animals, due to the process by which they are formed, these fatty acids are predominantly even-numbered, unbranched, aliphatic monocarboxylic acids with chain lengths ranging from C6 to C24. The chains can be either saturated or unsaturated. Unsaturated fatty acids differ in number and position of double bonds and in configuration (i.e. cis- or trans-isomers). Odd-numbered fatty acids do occur but are usually present in small quantities for example, undecanoic acid (C11) has been found in butter fat and heptadecanoic acid (margaric acid (C17)) has been found in the milk and body fat of ruminants). Other fatty acids with more unusual structures, such as branching or different side groups can be found in lower life forms such as algae or bacteria. Fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts covered by this exemption must be obtained from natural sources. 

Separation of the single fatty acids by distillation of the crude fatty acids originated from 

e.g. fats or oils are also covered by this exemption provided that no chemical modification of the individual fatty acids occurs. Hence their individual structures remain unchanged. 

The exemption includes: 

• groups of fatty acids which are saturated and/or unsaturated fatty acid having a range from C6 to C24 and their potassium, sodium, calcium and magnesium salts 
  
• single fatty acids which are saturated and/or unsaturated fatty acid ranging from C6 to C24 and their potassium, sodium, calcium and magnesium salts 

Examples:

fatty acids, olive oils; fatty acids, palm oil; fatty acids, sunflower oil; etc. and fatty acids, C8-16; fatty acids, C10-14; fatty acids, C8-18 and C18-unsatd.; calcium salts; fatty acids, tallow, sodium salts. 

hexanoic acid, octanoic acid, decanoic acid, and so on, up to tetracosanoic acid. It also includes hydroxyl-fatty acids obtained from natural sources, e.g. 12-hydroxy-9-cis- octadecanoic acid obtained from castor oil. 

Glycerol

Glycerol, which is also commonly called glycerine or propane-1,2,3-triol, forms the backbone of triglycerides bound to a number of fatty acids. 

Note: This exemption refers to glycerol which is obtained from natural sources as described above. Glycerol manufactured synthetically needs to be registered.