The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the no‐observed‐adverse‐effect‐level (NOAEL) approach for deriving a Reference Point (RP). The major change compared to the previous Guidance (EFSA SC, 2017) concerns the Section 2.5, in which a change from the frequentist to the Bayesian paradigm is recommended. In the former, uncertainty about the unknown parameters is measured by confidence and significance levels, interpreted and calibrated under hypothetical repetition, while probability distributions are attached to the unknown parameters in the Bayesian approach, and the notion of probability is extended to reflect uncertainty of knowledge. In addition, the Bayesian approach can mimic a learning process and reflects the accumulation of knowledge over time. Model averaging is again recommended as the preferred method for estimating the BMD and calculating its credible interval. The set of default models to be used for BMD analysis has been reviewed and amended so that there is now a single set of models for quantal and continuous data. The flow chart guiding the reader step‐by‐step when performing a BMD analysis has also been updated, and a chapter comparing the frequentist to the Bayesian paradigm inserted. Also, when using Bayesian BMD modelling, the lower bound (BMDL) is to be considered as potential RP, and the upper bound (BMDU) is needed for establishing the BMDU/BMDL ratio reflecting the uncertainty in the BMD estimate. This updated guidance does not call for a general re‐evaluation of previous assessments where the NOAEL approach or the BMD approach as described in the 2009 or 2017 Guidance was used, in particular when the exposure is clearly lower (e.g. more than one order of magnitude) than the health‐based guidance value. Finally, the SC firmly reiterates to reconsider test guidelines given the wide application of the BMD approach.

Monimax® is considered safe for turkeys for fattening at the highest use level of 50 mg monensin sodium and 50 mg nicarbazin/kg complete feed. The margin of safety is about 1.5. The simultaneous use of Monimax ® and certain antibiotic drugs (i.e. tiamulin) is contraindicated. Nicarbazin (equimolar complex of dinitrocarbanilide (DNC) and 2-hydroxy-4,6-dimethylpyrimidine (HDP)) has no antimicrobial activity. For both compounds of Monimax ® , the metabolic pathways in the chicken are similar to those in the turkey and rat. Monimax ® does not represent a genotoxic risk. No safety concerns would arise from the nicarbazin impurities p-nitroaniline and methyl(4-nitrophenyl) carbamate. The lowest no observed effect level (NOEL) identified for monensin sodium in a developmental study in rabbits was 0.3 mg monensin sodium/kg body weight (bw) per day for maternal toxicity in rabbits. The lowest no observed adverse effect level (NOAEL) identified in a 52-week study in rat using DNC + HDP was 20 mg DNC + 8 mg HDP/kg bw per day. No significant interaction between monensin sodium and nicarbazin is expected from toxicological studies. The use of Monimax ® at the highest proposed dose will not pose a risk to persons consuming animal products from treated turkeys for fattening. No withdrawal time is required for Monimax ® in turkeys for fattening. Residue data comply with the established maximum residue limits (MRLs) for monensin and DNC. Monensin sodium presents a hazard by inhalation and may also be associated with dermal toxicity. Monimax ® is not a skin irritant; however, no data are available for the eye irritation potential of monensin. Monimax ® is not a skin sensitiser. Based on the available data, the FEEDAP Panel cannot conclude on the safety of Monimax ® for the environment. Monimax ® has the potential to control coccidiosis in turkeys for fattening at a minimum concentration of 40 mg monensin sodium and 40 mg nicarbazin/kg complete feed.

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Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the leaves of Laurus nobilis L. (laurel leaf oil), when used as a sensory additive for all animal species. The additive contains up to 4% methyleugenol. The use of the additive at 2 mg/kg complete feed in dogs and cats was considered of low concern. For other long-living and reproductive animals, the use of the additive at 10 mg/kg was considered of concern. For short-living animals, the Panel had no safety concern when the additive is used at 10 mg/kg complete feed for turkeys for fattening, piglets and other growing Suidae, pigs for fattening, veal calves (milk replacer), cattle for fattening and other growing ruminants, horses and rabbits for meat production, salmonids and other fin fish; and at 8.5 mg/kg for chickens for fattening, other growing poultry and other minor species for fattening. The use of laurel leaf oil up to the highest level in feed which was considered of no concern for target animals was also expected to be of no concern for consumers. The additive should be considered as irritant to skin and eyes and the respiratory tract. Due to the high concentration of methyleugenol (≥ 1%), the additive was classified by the applicant as suspected of causing genetic defects and of causing cancer and should be handled accordingly. The use of the additive under the proposed conditions of use was not expected to pose a risk for the environment. Since the leaves of L. nobilis and their preparations were recognised to flavour food and their function in feed would be the same, no further demonstration of efficacy was considered necessary.

Copper is an essential micronutrient and also a regulated product used in organic and in conventional farming pest management. Both deficiency and excessive exposure to copper can have adverse health effects. In this Scientific Opinion, the EFSA 2021 harmonised approach for establishing health‐based guidance values (HBGVs) for substances that are regulated products and also nutrients was used to resolve the divergent existing HBGVs for copper. The tightly regulated homeostasis prevents toxicity manifestation in the short term, but the development of chronic copper toxicity is dependent on copper homeostasis and its tissue retention. Evidence from Wilson disease suggests that hepatic retention is indicative of potential future and possibly sudden onset of copper toxicity under conditions of continuous intake. Hence, emphasis was placed on copper retention as an early marker of potential adverse effects. The relationships between (a) chronic copper exposure and its retention in the body, particularly the liver, and (b) hepatic copper concentrations and evidence of toxicity were examined. The Scientific Committee (SC) concludes that no retention of copper is expected to occur with intake of 5 mg/day and established an Acceptable Daily Intake (ADI) of 0.07 mg/kg bw. A refined dietary exposure assessment was performed, assessing contribution from dietary and non‐dietary sources. Background copper levels are a significant source of copper. The contribution of copper from its use as plant protection product (PPP), food and feed additives or fertilisers is negligible. The use of copper in fertilisers or PPPs contributes to copper accumulation in soil. Infant formula and follow‐on formula are important contributors to dietary exposure of copper in infants and toddlers. Contribution from non‐oral sources is negligible. Dietary exposure to total copper does not exceed the HBGV in adolescents, adults, elderly and the very elderly. Neither hepatic copper retention nor adverse effects are expected to occur from the estimated copper exposure in children due to higher nutrient requirements related to growth.