ATTACHMENT 2: YEAST24

Gewijzigd op Do, 17 Okt, 2024 om 12:20 PM

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as a living or dead organism it is not considered a substance, a mixture or an article under the REACH Regulation (see draft guidance on Annex V(7) and Annex V(8).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, and possibly (but not necessarily) also enhanced, and with further isolation. Additionally, this type of yeast extract is not the result of any of the processes mentioned under Annex V(1), Annex V(2), Annex V(3) or Annex V(4) and therefore not exempted under any of these sections of Annex V.

The above applies irrespective of whether the natural yeast extract has the same chemical identity and properties as a yeast extract resulting from a chemical modification of biomass by other means than those of Article 3(39).

Finally, the application of Annex V(9) to yeast extract was tackled in the GRIP document, as it was argued that the process to obtain the yeast extract is similar to the hydrolysis process used to obtain fatty acids. In this context, it is important to note that the list of substances exempted through Annex V(9) is a closed list, and only those substances listed therein could benefit from this exemption (when meeting the conditions of the exemption).

The idea of amending Annex V(9) of REACH to read "substances such as the ones listed" is not acceptable to the Commission, as it will open the door to the exemption for registration, evaluation and downstream user provisions to an unknown number of substances and processes. Such an approach was not favoured during the recent review of Annexes IV and V25, when entry 9 was added to Annex V in the form of an exhaustive list with strict conditions, as it reads after the amendment.

Commission views on vinasses solution, vevomix and kalimix

The GRIP paper argues that vinasses solution comply with the definition of naturally occurring substance in accordance with Article 3(39), as they are obtained by centrifugation of fermentation mass out of bakers yeast grown by fermentation. Vevomix and kalimix are obtained by further concentration by evaporation and centrifugation of vinasses solution. The GRIP paper bases its conclusion on the fact that none of the processing steps involve chemical modifications, while concentration and centrifugation are covered by Article 3(39) as processes that do not alter the status of naturally occurring substances.

The Commission notes that the first step in determining whether vinasse, vevomix and kalimix benefit from the Annex V (8) exemption, is to identify the status of the substance which results from fermentation i.e. whether the 'fermentation mass' (as presented in the GRIP paper) or the substance that results from fermentation of molasses by bakers yeast is a naturally occurring substance. Should that be the case, indeed the step of centrifugation that follows the fermentation is one of the processes covered by Article 3(39) and the exemption would be open to these substances.

25 COMMISSION REGULATION (EC) No 987/2008 of 8 October 2008 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes IV and V.

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.

It is the Commission’s understanding that the production of vinasses is a man-made fermentation process of molasses by yeast. During this process, molasses (more particularly, sugars contained therein) are chemically transformed by yeast into other substances, for example one or more alcohols (components of vinasses). In this process yeast is acting as a biocatalyst during the chemical transformation and after it has fulfilled its biocatalyst function it can further be processed, for example, into yeast extract (see figure in page 2).

Article 3(39) contains a closed lists of activities which can be considered to process naturally occurring substances without altering such status. The nature of this list as a limited enumeration of processes is confirmed by the use of the term 'only' ("[…] or processed only by […]"). Since fermentation is not specifically listed in Article 3(39), it cannot be understood as one of the operations allowed for the sake of keeping within the definition of processed substances which occur in nature. Furthermore, due to the controlled (bio)chemical transformation taking place, ‘fermentation mass’ cannot be understood as an ‘unprocessed’ substance in accordance with Article 3(39).

On the basis of the explanation given above and in the GRIP paper, the Commission is of the opinion that the substance resulting from a man-made fermentation of molasses by bakers yeast is not naturally occurring, but the result of a chemical transformation of molasses through a man-made fermentation process by yeast. Consequently, the exemption in Annex V(8) is neither applicable to vinasses nor to the derived products vevomix and kalimix.

Conclusion

The Commission believes that yeast extract can be considered a naturally occurring substance if the lysis of yeast cells is a result of a mechanical process or if it is only processed by any processes listed in Article 3(39). In the case at hand, as presented in the GRIP paper, in which yeast extract is obtained in a process of 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), the Commission believes that yeast extract is not a naturally occurring substance and thus cannot benefit from the exemption under Annex V(8).

Additionally, the Commission believes that yeast extract cannot benefit from the exemption under Annex V(9), as it is not one of the substances listed. The Commission is not considering amending Annex V(9) of REACH to change the nature of the list of exempted substances from a closed list to an open one.

The Commission believes that vinasses solution, vevomix and kalimix cannot benefit from the exemption in Annex V(8) of REACH, as they are not the result of processing that is allowed under Article 3(39) for a naturally occurring substance.

These conclusions are without prejudice to the fact that to the extent yeast extract or vinasse is used in food or feedingstuffs in accordance with Regulation (EC) No 178/2002, it is exempted from Titles II, IV, V, VI and VII in line with Articles 2(5)(b) and 2(6)(d) of REACH.

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