The European Commission has just published a Regulation (EU 2019/1964, OJ L 307/3, 28.11.2019) re-authorising several forms of lysine for the EU market.
This Regulation closes the re-authorisation cycle of amino acids, initiated 16 years ago by Regulation 1831/2003. According to this, the amino acids that were previously authorised had to go through a tree-steps process (notification, application, evaluation), with only those successfully fulfilling the requirements at each of them remaining on the market. Following previous re-authorisation of other amino acids, this last-in-the-row Regulation marks the end of a lengthy process for the amino acids.
Besides some nomenclature modifications, the Regulation introduces important changes regarding the authorised lysines supply sources/manufacturing process, which are much more precise, and restricted, than was the case so far. The authorised products, which all result from an industrial fermentation process, are indeed strain-specific, implying that only the listed strains can be used for their manufacture, at the exclusion of any other strain. This approach is based on the safety assessment of the product, carried out by EFSA, which recognises the micro-organism strain and its grow conditions as an important determinant of the final product safety. The EFSA safety evaluations generally include further considerations (e.g. regarding purification) that are specific to the product that was submitted to their scrutiny, which are not necessarily part of the legal act but might be relevant regarding other compliance aspects or product characteristics.
The Table below summarises the authorised products (including one that was previously authorised) and the strains with which they can be manufactured.
| Product | Code | Production species | Strain number | Legal act |
| L-lysine base, liquid* | 3c320 | Escherichia coli | FERM BP-10941 FERM BP-11355 | (EU) 2019/1964 |
| 3c320 | Corynebacterium glutamicum | KCCM11117P NRRL B-50547 NRRL B-50775 KCCM 10227 | (EU) 2019/1964 | |
| L-lysine monohydrochloride, liquid** | 3c321 | Escherichia coli | FERM BP-10941 FERM BP-11355 | (EU) 2019/1964 |
| L-lysine monohydrochloride, technically pure | 3c322 | Escherichia coli | FERM BP-10941 FERM BP-11355 CGMCC 3705 CGMCC 7.57 | (EU) 2019/1964 |
| 3c322 | Corynebacterium glutamicum | NRRL B-50547 NRRL B-50775 KCCM 11117P KCCM 10227 | (EU) 2019/1964 | |
| L-lysine sulphate | 3c324 | Corynebacterium glutamicum | KCCM 10227 DSM 24990 | (EU) 2019/1964 |
| 3c323 | Escherichia coli | CGMCC3705 | (EU) 2017/439 |
*previously named “concentrated liquid
L-Lysine (base)”
**previously named “concentrated liquid L-Lysine monohydrochloride”
These strains are proprietary, and although the identification of the applicant/producer is not explicit in the authorisation, these authorisations are practically very close to company-specific (“holder-specific”) authorisations. This might create a small challenge throughout the value chain since the strain identification is so far not a compulsory element of the label requirements under the Feed Additive Regulation and additive code numbers do not provide proper differentiation. The producers are responsible for placing only authorised additives on the market, and the users have an important counter-responsibility not to accept or use unauthorized products. In order to facilitate the necessary transparency and regulatory compliance in this area, some producers are voluntarily including the strain identification in their product labelling. This allows a quite easy traceability over the value chain, avoiding that unauthorized products might enter the chain. In the frame of a potential revision of Regulation 1831/2003 providing the deposition code of the producer strain should become a compulsory labeling requirement. This would allow importers, users, custom and inspection officers to maintain a fair market playing field. It might furthermore be sensible to switch such fermentation products to the holder-specific regime at this opportunity.
One does appreciate that, besides the safety-based specificity it introduces, this is also bringing a challenge regarding the diversity of available sources. The authorised strain now belong to a handful number of companies, with some other being out of the EU game. Though some further applications are in the evaluation pipe, the schedules for them to reach the authorisation stage are difficult to predict reliably.
The Feed grade amino acids are a basis for precision feeding and a pivotal element of a sustainable protein supply, and access to them has a particular importance in a context where the sustainability of the feed chain and production models is attracting increasing attention at International and EU level, with growing importance of various assessment tools (i.e, FAO Leap methodology, GFLI data base, PEFCR (Product Environment Footprint Category Rules) at EU level , etc.).
The new Regulation has foreseen a transition period in order to drain products that were authorised under the former regime. These additives and premixtures made of them can be placed on the market until 18 June 2020. The compound feeds that include these substances and are manufactured and labelled before 18 December 2020 may be placed on the market and used until stocks are exhausted. The change of playing field brought in by this new authorisation might shake up certain positions. The transition period being relatively limited, it is important for users to swiftly adapt to the new situation and, possibly, for producers to readily move towards further products authorisation.