GM microbes: Rising calls to reject the lowering of EU standards

Today, 36 civ­il soci­ety organ­i­sa­tions from 12 coun­tries wrote to Mem­bers of the Euro­pean Par­lia­ment (MEPs) call­ing on them to reject plans to low­er EU safe­ty require­ments for the envi­ron­men­tal release of genet­i­cal­ly mod­i­fied microor­gan­isms (GMMs), includ­ing bac­te­ria, yeasts, algae and virus­es. The appeal fol­lows an ear­li­er call from Euro­pean eco­log­i­cal sci­en­tists to main­tain robust safe­guards for the release of GMMs into the envi­ron­ment.

Broad coalition urges caution

Save Our Seeds has joined organ­i­sa­tions work­ing in envi­ron­men­tal pro­tec­tion, con­sumer rights, agri­cul­ture, bee­keep­ing, food pro­duc­tion and sci­ence in call­ing on the Euro­pean Par­lia­ment to retain strict reg­u­la­tion of GMMs released into the envi­ron­ment.

Our organ­i­sa­tions argue that exist­ing safe­guards should not be weak­ened while the tech­nol­o­gy is devel­op­ing rapid­ly. Advances in genet­ic engi­neer­ing, includ­ing its grow­ing con­ver­gence with arti­fi­cial intel­li­gence, are expand­ing the capac­i­ty to cre­ate microor­gan­isms with nov­el genet­ic char­ac­ter­is­tics that may have no direct coun­ter­part in nature. This rapid tech­no­log­i­cal devel­op­ment makes robust reg­u­la­tions all the more impor­tant.

What has been proposed?

The Com­mis­sion pro­pos­al, pre­sent­ed on 16 Decem­ber 2025 as part of the Euro­pean Biotech Act, would amend Direc­tive 2001/18/EC to intro­duce spe­cif­ic rules for the com­mer­cial release of GMMs into the envi­ron­ment. The Com­mis­sion describes it as a more tai­lored and stream­lined frame­work intend­ed to main­tain a high lev­el of safe­ty.

The Coun­cil already adopt­ed its Gen­er­al Approach in June, with only minor amend­ments to the Com­mis­sion text.

In prin­ci­ple, the pro­pos­al does not cov­er GM microor­gan­isms used in food and feed, which are sub­ject to sep­a­rate EU leg­is­la­tion. It con­cerns GMMs intend­ed for uses such as biofer­tilis­ers, biopes­ti­cides and the biore­me­di­a­tion of pol­lut­ed sites. GMMs mar­ket­ed as cos­met­ic prod­ucts would be cov­ered, where­as GMMs used as feed addi­tives would not.

While the EU has some expe­ri­ence with the reg­u­la­tion of GM plants, no GM microor­gan­ism has so far been autho­rised for plac­ing on the mar­ket under the EU GMO frame­work. Nev­er­the­less, the Com­mis­sion makes the fol­low­ing pro­pos­als to reduce the exist­ing require­ments for the delib­er­ate release of GMMs into open ecosys­tems:

• Unlim­it­ed autho­ri­sa­tions: autho­ri­sa­tions for plac­ing GMMs on the mar­ket would no longer be lim­it­ed to 10 years. The Com­mis­sion says this would reduce the admin­is­tra­tive bur­den for oper­a­tors and nation­al com­pe­tent author­i­ties.
• Reduced infor­ma­tion require­ments: infor­ma­tion require­ments would be “adapt­ed” to take account of the spe­cif­ic char­ac­ter­is­tics of GMMs, although Direc­tive 2001/18/EC already allows cer­tain flex­i­bil­i­ty in the infor­ma­tion required.
• Reduced detec­tion require­ments: require­ments con­cern­ing the detec­tion, iden­ti­fi­ca­tion and quan­tifi­ca­tion of GMMs would be adapt­ed where it is “not fea­si­ble” to pro­vide an appro­pri­ate method. This could lim­it the capac­i­ty to mon­i­tor the spread of released GMMs and to detect the trans­fer of genet­ic mod­i­fi­ca­tions to oth­er organ­isms with­in micro­bial com­mu­ni­ties.

In addi­tion, the Com­mis­sion pro­pos­es a new cat­e­go­ry of “low-risk GMMs” that would ben­e­fit from a more stream­lined autho­ri­sa­tion pro­ce­dure and reduced infor­ma­tion require­ments. In cer­tain cas­es, post-mar­ket envi­ron­men­tal mon­i­tor­ing could also be waived.

To qual­i­fy for this cat­e­go­ry, a GMM would have to meet three con­di­tions: the microor­gan­ism would have to be “well-char­ac­terised”, it would have to appear on the EU list of microor­gan­isms with a Qual­i­fied Pre­sump­tion of Safe­ty (QPS), and it would have to con­tain no “genes of con­cern” that are not already present in the parental organ­ism.

Ecological scientists call for removal of “low-risk” category

In their recent­ly pub­lished cri­tique of the EU pro­pos­al, mem­bers of eco­log­i­cal sci­ence soci­eties from across Europe call for the pro­posed “low-risk” GMM cat­e­go­ry to be removed. They argue that there is cur­rent­ly “no com­pre­hen­sive frame­work for quan­ti­fy­ing GMM-asso­ci­at­ed risks across all micro­bial taxa, genet­ic loca­tions of mod­i­fi­ca­tions, and types of mod­i­fi­ca­tions”. They call for such a frame­work to be “devel­oped urgent­ly” before a hypo­thet­i­cal “low-risk” cat­e­go­ry is intro­duced that could cre­ate major and poten­tial­ly irre­versible envi­ron­men­tal risks.

The sci­en­tists warn that “GMMs will evolve and spread fast and inter­act with myr­i­ads of oth­er organ­isms”, poten­tial­ly desta­bil­is­ing local eco­log­i­cal inter­ac­tion net­works and dis­plac­ing native micro­bio­ta. They argue that sim­ply clas­si­fy­ing cer­tain GMMs as “low-risk” does not resolve the fun­da­men­tal uncer­tain­ty sur­round­ing their use in agri­cul­tur­al and nat­ur­al envi­ron­ments.

In addi­tion to remov­ing the pro­posed “low-risk” cat­e­go­ry, the sci­en­tists call for case-spe­cif­ic, “eco­log­i­cal­ly informed” envi­ron­men­tal risk assess­ments; manda­to­ry long-term mon­i­tor­ing; basic checks on the func­tion­ing of pro­posed GMMs through “mean­ing­ful but high­ly con­fined field tri­als”; and time-lim­it­ed autho­ri­sa­tions adapt­ed to the biol­o­gy of GMMs.

MEPs urged to maintain strong safeguards

The 36 organ­i­sa­tions behind the joint appeal sim­i­lar­ly call on MEPs not to weak­en EU safe­ty stan­dards for GMMs. They call for all GMM autho­ri­sa­tions to remain time-lim­it­ed and sub­ject to peri­od­ic renew­al, with reli­able detec­tion meth­ods and case-spe­cif­ic envi­ron­men­tal mon­i­tor­ing required in every case. They also demand the “urgent enhance­ment of risk assess­ment method­olo­gies and post-release mon­i­tor­ing sys­tems” and full, case-spe­cif­ic envi­ron­men­tal risk assess­ment in line with cur­rent stan­dards.

Par­tic­u­lar atten­tion should be giv­en to microor­gan­isms that are known to be essen­tial com­po­nents of the micro­bio­mes of soils, plants, ani­mals and humans. The organ­i­sa­tions argue that these micro­bial com­mu­ni­ties play fun­da­men­tal roles in healthy ecosys­tems, food pro­duc­tion and human and ani­mal health and there­fore require the high­est lev­el of pro­tec­tion. Where the unin­tend­ed spread of a GMM can­not be effec­tive­ly con­trolled or mit­i­gat­ed, they argue that autho­ri­sa­tion should not be grant­ed.

What is next?

The Euro­pean Parliament’s Envi­ron­ment and Pub­lic Health Com­mit­tees are expect­ed to vote on the pro­pos­al on 4 Novem­ber. The ple­nary vote is sched­uled for the Parliament’s Brus­sels mini-ple­nary on 11–12 Novem­ber. Once the Par­lia­ment has adopt­ed its posi­tion, tri­logue talks will begin with the Coun­cil and the Com­mis­sion to agree on a final text.

Image: Dig­i­tal­ly col­orized micro­scope image of a wild-stream sam­ple show­ing bac­te­ria, pro­to­zoa, and algae. © Jan­ice Haney Carr