New EU NGT Regulation (EU)

It would appear that the long awaited development of a new EU approach to regulate NGTs (New Genomic Techniques) outside of current GMO rules, is nearing fruition. Presently, by reason of a decision of the European Court, NGTs are regulated as GMOs.

On 15th June, ARC2020 published the latest EU Regulation draft here.

A draft has also been reviewed by the FT – FT states “The plan would establish a category of plants that have used gene editing to create new varieties but could have been achieved through traditional breeding techniques. They include wheat that can withstand drought, tomatoes resistant to fungus and potatoes containing less acrylamide, which becomes carcinogenic when fried.”

New genomic techniques (NGT) are introduced in the proposed EU Regulation as an umbrella term for certain genetic engineering technologies aiming to alter the DNA more precisely than “old” methods by directing the changes to predefined loci of the genome. The most prominent and popular of these technologies is CRISPR-Cas.

Within a broad spectre of GMOs, ARC2020 (reviewing the proposed EU Regulation) state the proposed EU Regulation will deem “NGTs Category 1” to be equivalent to conventionally bred plants and no longer to require a prior case by case risk assessment. A notification by the producers themselves to national competent authorities would be enough. No public label of the product as GMO will be required. Only the seed would bear a label “new genomic technique category 1”. A public register will list all plants accepted as NGT1. No unique identifier of the GMO nor any other method of tracing the trait and its possible outcrossing will be required.

The proposed criteria to establish the equivalence of NGTs to conventional plants and their deregulation, will allow for up to 20 different genetic modifications per plant of small insertions (up to 20 nucleotides), any number of deletions or inversions of DNA and any introduction of DNA sequences from within the so-called breeders gene pool. As a single exemption, herbicide tolerance of the GMO would disqualify it from category 1.

Any other NGTs, which entail even bigger insertions of DNA, would be subject to a “risk assessment light” requiring a more detailed analysis. A special feature as regards labelling of these GMOs is the opportunity to add any promotional language regarding their properties.

Measures to prevent the contamination of non-GMO cultivation and processing will be left to the individual member states. Their right to opt out of approvals for cultivation, as foreseen in the present GMO regulation, is withdrawn. However, the ban on GMO use, including NGT 1, in organic farming, will continue.

ARC2020 report the draft also proposes to delegate to the Commission the power of changing the crucial definitions in the Annexes of the regulation and to adopt implementing acts regarding the required notification information and risk assessments without the Parliament and the Council.

REUL Bill Update (UK)

This Bill (in my blog before) is now before the House of Lords, today and on Wednesday, for its Report Stage (one of the last stages before Royal Assent).

The UK Government recently confirmed it would delete the 31st December 2023 sunset clause, and its extension date in 2026, except for a list of EU-era documents. This list is now published – it would be an inserted Schedule to the Bill.

Find here, the collated amendments to the Report Stage of the REUL Bill, including the contents of the proposed new Schedule (of deletions by 31st Dec 2023). Note: the UK Government (Lord Callanan) has also proposed to enable devolved governments to remove items from his proposed Schedule.

On this Schedule (list of deletions by 31st Dec 2023) – (assuming Royal Assent of the list as is) –

(1) Removal of Annex 8 to the UK CLP document – here is a link to EU ECHA on the purpose of Annex 8. The UK CLP document is a version of the EU-era CLP (Classification, Labelling and Packaging) Regulation.

(2) Deletion of recent changes to Annex 1 of the EU-era PIC Regulation – a 2019 local instrument made changes to Annex 1 but these are not showing on the legislation dot gov dot uk website, and so we will need to produce a Cardinal Environment text consolidation for this PIC document. Annex 1 lists the chemicals covered by the EU-era PIC Regulation.

(3) Deletion of various EU-era instruments regulating establishing standardised application information when GMOs are to be deliberately released to the market or the environment. The UK now has a Precision Breeding Act regulating PBOs (Precision Bred Organisms) as distinct from GMOs (Genetically Modified Organisms). Under the new Act, the developer no longer “applies” but “notifies”. But developers still must “apply” under EU-era rules for the deliberate release of GMOs into the market/into the environment. It would appear DEFRA intends (by deleting the EU-era rules in this area) to change this to a “notification” process. The GMO register (of genetic modifications in GMOs) being lost in the REUL deletion process would be replaced by the PBO register under the Act. PBOs and GMOs would seemingly co-exist, in regulation terms.

The above would need to be achieved by issue of Statutory Instrument. Hopefully, further information will be available at that point.

We will amend the REUL List showing on client systems. and we will change the colour coding. However, we will retain the REUL List as a whole, since changes may occur to these EU-era rules over time, but not subject to a deadline.

Also note – the UK Government made two additional announcements (at the time of announcing the removal of the 31st Dec 2023 sunset deadline and it’s extension) –

(A) (EU-era) Working Time Regulations – these would be amended a bit, but the 48 hour week would be retained and also the combined leave provisions would still exceed the minimum in the EU.

(B) (EU-era) TUPE Regulations – these would be adjusted a bit. These rules are outside our remit.

GMO Regulation Changes (England)

In its first Brexit de-regulation foray (of relevance to this blog) – the UK government today seeks views on its plans to change its regulation of genetically modified organisms (GMOs) in England – here.

The consultation ends on 17 March 2021.

Part 1 of the consultation focuses on the regulation of gene edited (GE) organisms possessing genetic changes which could anyway have been introduced by traditional breeding.

Part 2 of the consultation engages separately and starts gathering views on the wider regulatory framework governing genetically modified organisms (GMOs).

Depending on the results of part 1, DEFRA may change the legislation to amend the definition of a GMO as it applies in England. Currently GMOs are defined in section 106 of the Environmental Protection Act 1990 (amended by the GMO Deliberate Release Regulations). This would mean that the law would not apply to organisms produced by gene editing (GE) and other genetic technologies if they could have been developed using traditional breeding methods. DEFRA’s view is that organisms produced by GE or by other genetic technologies should not be regulated as GMOs if they could have been produced by traditional breeding methods.

The responses from part 2 of the consultation will be used by the UK government to inform policy development and stakeholder engagement plans on any potential wider GMO reform.

On 25 July 2018 the Court of Justice of the European Union (CJEU) clarified that organisms obtained by mutagenesis are genetically modified organisms (GMOs) as defined in the European Directive 18/2001/EC. The journal Nature has a useful summary article on this technical field – here.

Note – the Court also clarified that organisms obtained by mutagenesis techniques which have conventionally been used in a number of applications and have a long safety record are exempt from those obligations, on the understanding that the Member States are free to subject them, in compliance with EU law, to the obligations laid down by the directive or to other obligations.

The ECJ Press Release on the matter is here.