The Omnibus package would reopen around a dozen key EU rules on food and feed safety. It particularly weakens weakens safety checks that currently exist in the pesticides and pesticides residues regulations. It eases market access conditions for companies and weakens the ability of authorities to mobilise the latest scientific evidence in order to restrict substances that pose a risk for health or the environment.
Key measures include:
1. Making unlimited approvals for pesticide active substances the rule
Contrary to the current situation , under the new proposal, most active substances that will be put on the market will get unlimited access.
Time-limited approvals will only be possible for:
- substances identified as candidates for substitution,
- substances approved under specific, time-limited, derogations, or
- substances that sparked major debate during the assessment because of uncertainties.
This is dangerous because it changes significantly the logic of the regulation. To date, it has mostly been at periodic renewals that substances have been banned (e.g. Mancozeb, Chlorpyrifos). Indeed, it is often at this step that new scientific evidence emerges that allows regulators to take action. Removing by default this period review puts health and the environment at risk.
The possible derogations proposed are too weak. Likewise, the Commission tries to reassure by introducing the possibility to periodically draw up lists of substances that would still have to undergo a renewal based on indications of safety concerns. But it will be the only institution with the initiative to do so. Also, while the Commission will be able to propose substances for review, it will not have the obligation nor any periodic constraints to do so.
An important aspect of this proposal is that all active substances already on the market at the time of entry into force of the omnibus will benefit from unlimited approval. Exceptions will only apply if these substances are candidates for substitutions, if they have been approved under time-limited derogations, or if a dossier for renewal was already submitted (or during assessment) at time of entry into force of omnibus. Still, the fact is that most active substances on the market would benefit from a default lifetime approval.
Finally, the Commission proposes that pesticides products – meaning the final mixture of an active substance plus safeners or synergists -would still remain under time-limited authorisations of maximum 15 years, even if the active substance that they contain benefits from an unlimited authorisation.
At first glance, this might sound like a good safeguard. However, it could be counterproductive. It will not reduce the workload of national authorities because they would still regularly assess and re-authorise products at national level. At the same time, their assessments might be based on less up-to-date scientific evidence, because the active substance would no longer need regular renewal—and companies would therefore have less obligation to submit new studies over time.
Therefore, overall, the proposal to make authorisations of active substances unlimited by default put health and the environment at risk and the proposed exceptions and adaptations are too weak.
2. Extending grace periods for banned substances
The omnibus proposal brings more flexibility for companies whose substances get banned to get rid of their stocks. For the majority of cases, a grace period of up to 18 months is proposed -6 months for sale and distribution and another year for storage and use of existing stocks.
However, this period can go up to 3 years in cases when 'there are no other available reasonable means to plant protection products containing the active substance concerned'. This is very vague wording that will leave lots of flexibility for industry players to argue for continued use of their substances and make it uncertain who will define what a ‘reasonable’ alternative is and under which criteria.
3. Legal derogations for the approval of harmful active substances
The proposal amends existing possibilities for derogations of approval of dangerous substances. Article 4(7) foresees the possibility for time-limited derogations for substances deemed to be ‘necessary to control a serious danger to plant health or plant production that cannot be contained by other reasonable means including non-chemical methods’.
While this derogation cannot apply for substances that officially identified under EU law for health or environmental effects (e.g. known or presumed to carcinogens, mutagens, reprotoxicants, highly persistent or bioaccumulative substances), this would still allow substances with scientific evidence of harm for health or the environment that may not be officially classified to get onto the market.
4. Integration of the latest scientific knowledge in assessments
The text reduces the margin of manoeuvre of Member States when they will conduct assessments. They will have to rely on the last assessment of the active substance at EU level. If they think the scientific knowledge needs to be updated, they will have to request the Commission to do so. But this means that their leverage to take onboard the latest scientific evidence will be reduced.
5. Contradictions in the proposed actions on pesticides residues
On the one hand, the Commission proposes to act on residues from pesticides banned in the EU coming back via imports, which foodwatch has long asked for. It would revoke maximum residue limits (MRLs) set based on values implemented in third countries. But the text also introduces uncertainty by suggesting that action will be taken ‘if considered appropriate in the light of the outcome of an impact assessment’ (article 14 of the MRL Regulation 396/2005). This is dangerous because it suggests that the Commission will still integrate socio-economic considerations in its decisions to revoke MRLs for residues of banned pesticides coming back via imports.
On the other hand, the proposal also confirms that the Commission intends to relax current rules for setting and lowering maximum residue levels over time.
- In line with proposals for pesticides active substances, the Commission suggests to end periodic 10-year reviews of temporary MRLs (changes in articles 15 and 16). While technically, it will always be possible for the Commission to suggest changes, it brings less systematic opportunities to integrate the latest available knowledge to question acceptable residue levels over time.
- Even in cases where an MRL is lowered over time, the Commission proposes to allow the use of the value applicable to food products when they entered the market supposedly to avoid food loss and food waste (articles 14 and 18). This ignores that MRLs get decreased over time due to the emergence of scientific evidence on harm for health or the environment and is not acceptable.
Alarming attack on EU food safety rules: foodwatch warns against “Omnibus” overhaul
Overall, the Commission’s proposals to change European regulations for pesticides and pesticides residues are not acceptable for foodwatch because they put consumers and the environment at risk. We will be calling on the Parliament and Council to reject these proposals during the next steps of the legislative process.