ATTACHMENT 2: YEAST24

Background: 

The issue of the status of yeasts under REACH had been discussed in the realm of REHCORN. In this context, answers had been provided for this issue, indicating that yeast extract was subject to registration. NL decided to bring this issue up to the attention of Competent Authorities in December 2008, by circulating a paper on the status of yeast extract and vinasses and requesting the opinion of the GRIP. 

NL communicated its view that yeast extract and vinasses should be considered as parts of naturally occurring substances and are exempted from the REACH registration requirements. A number of Member States supported this view, but DE was of the opinion that yeast extract and vinasses should be considered as substances which are produced in manufacturing processes including biotechnological processes, and were therefore not exempted from the REACH registration requirements. 

NL developed a document for review by GRIP. Three comments were received not showing a unanimous opinion. Based on these comments a GRIP paper was finalised with the intention to bring this issue forward to the CARACAL meeting on 16 and 17 March 2009. The Commission has been asked to express its views on the issue. 

Commission views on the issue of yeast extract 

Yeasts under REACH 

Yeast is a microorganism and consequently, as a living or dead organism it is not considered a substance, a mixture or an article under the REACH Regulation (see draft guidance on Annex V(7) and Annex V(8). In this context, it is not relevant whether yeast has been grown in nature or via a man-made cultivation. 

At the end of life, dead yeast cells and their content undergo degradation upon an action of enzymes released from dead cells. This process is called autolysis. 

Yeast extract under REACH 

Yeast extract is different from yeast as it results from the chemical modification of dead yeast biomass through a two step process: (i) lysis of yeast cells due to action of its own enzymes, which may or may not be enhanced and followed by application of physical, chemical and/or enzymatic inducers (which results in lysed yeast) and (ii) isolation of yeast extract from the lysed yeast cells using processes such as centrifugation. After its isolation, the yeast extract could be further treated (e.g. pasteurised) for its further use or placing on the market. 

Yeast extract could be considered a naturally occurring substance if, following lysis of yeast cells by mechanical processing, it is isolated by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water (see Article 3(39)). Naturally occurring lysed yeast and naturally occurring yeast extract benefit from the exemption under Annex V(8) if they comply with the conditions of the exemption, namely: 

• not being chemically modified (in accordance with Article 3(40)) 
  
• not meeting the criteria for classification as dangerous 
  
• not being a PBT or a vPvB 

not having been identified in the candidate list for authorisation at least two years previously as a substance of equivalent level of concern under Article 57(f). 

However, to the Commission's knowledge yeast extract is generally obtained through a process by which the rupture of the yeast cells (lysis) is not the result of a mechanical process or any other process listed in Article 3(39), but of the chemical lysis of the yeast by other means than those of Article 3(39), either by the yeast's own enzymes or man- enhanced for example (but not exclusively) by adding salt or enzymes, and followed by isolation (typically involving centrifugation). Under these circumstances, the yeast extract is not a naturally occurring substance within the scope of Article 3(39) definition, as the substance cannot be considered unprocessed or processed only by means enumerated in Article 3(39), as it has been generated by a chemical modification of biomass by other means than those of Article 3(39) under the influence (action) of the yeast own enzymes,

24 Unsolved interpretation questions - yeast CA/39/2009, 2nd Meeting of the Competent Authorities for REACH and CLP (CARACAL), 15-16 June 2009, Centre A. Borschette Rue Froissart 36, 1040 Brussels, Belgium.