Peer review of the pesticide risk assessment of the active substance paraffin oil (CAS 72623‐86‐0, chain lengths C19–C28)

TL;DR

This paper summarizes the peer review of the pesticide risk assessment for paraffin oil used on seed potatoes.

Contribution

It provides conclusions and concerns from the peer review process under EU regulations.

Findings

The peer review evaluated the use of paraffin oil as an insecticide on seed potatoes.

Reliable endpoints for regulatory risk assessment were identified.

Missing information and concerns were highlighted.

Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Greece, and co‐rapporteur Member State, France, for the pesticide active substance paraffin oil (CAS 72623‐86‐0) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of paraffin oil (CAS 72623‐86‐0) as an insecticide on seed potatoes. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Figures

Tables

TABLE 1. Soil.

Compound (name and/or code)	Ecotoxicology
Paraffin oil (CAS 72623‐86‐0)	Low risk for single and multiple applications at 5 kg a.s./ha (Olie‐H) and for single applications at 9.68 kg a.s./ha (Finavestan EMA) in seed potatoes. High risk for multiple applications at 9.68 kg a.s./ha (Finavestan EMA) in seed potatoes

TABLE 2. Groundwater. a

Compound (name and/or code)	> 0.1 μg/L at 1 m depth for the representative uses b	Biological (pesticidal) activity/relevance	Hazard identified	Consumer risk assessment triggered	Human health relevance
	Step 2	Step 3a	Steps 3b and 3c	Steps 4 and 5
Paraffin oil (CAS 72623‐86‐0)	No	Yes	–	–	Yes

TABLE 3. Surface water and sediment.

Compound (name and/or code)	Ecotoxicology
Paraffin oil (CAS 72623‐86‐0)	Low risk to fish, algae and sediment‐dwelling organisms for single and multiple applications in seed potatoes High acute risk to aquatic invertebrates for single and multiple applications in seed potatoes Chronic risk assessment not finalised for aquatic invertebrates for single and multiple applications in seed potatoes

TABLE 4. Air.

Compound (name and/or code)	Toxicology
Paraffin oil (CAS 72623‐86‐0)	Low acute inhalation toxicity LC50 > 5 mg/L air

TABLE 5. Risk mitigation measures proposed for the representative uses assessed.

Representative use	Seed potatoes
	1 × 9.68 kg a.s./ha	10 × 9.68 kg a.s./ha	2 × 5 kg a.s./ha	12 × 5 kg a.s./ha
Risk to aquatic organisms	5 m BZ or 50% DRN	10 m BZ or 50% DRN

TABLE 6. Overview of concerns reflecting the issues not finalised, critical areas of concerns and the risks identified that may be applicable for some but not for all uses or risk assessment scenarios.

Representative use		Seed potatoes
		1 × 9.68 kg a.s./ha	10 × 9.68 kg a.s./ha	2 × 5 kg a.s./ha	12 × 5 kg a.s./ha
Operator risk	Risk identified
	Assessment not finalised
Worker risk	Risk identified
	Assessment not finalised
Resident/bystander risk	Risk identified
	Assessment not finalised
Consumer risk	Risk identified
	Assessment not finalised
Risk to wild non‐target terrestrial vertebrates	Risk identified
	Assessment not finalised
Risk to wild non‐target terrestrial organisms other than vertebrates a	Risk identified		X b
	Assessment not finalised	X2	X2,3	X2	X2,3
Risk to aquatic organisms	Risk identified	X c	X c	X c	X c
	Assessment not finalised	X1	X1	X1	X1
Groundwater exposure to active substance	Legal parametric value breached
	Assessment not finalised
Groundwater exposure to metabolites	Legal parametric value breached
	Parametric value of 10 μg/L breached
	Assessment not finalised

Full text

SUMMARY

Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659, lays down the procedure for the renewal of the approval of active substances submitted under Article 14 of Regulation (EC) No 1107/2009. The list of those substances is established in Commission Implementing Regulation (EU) No 686/2012 as amended by Commission Implementing Regulation (EU) No 2016/183. Paraffin oil (CAS 72623‐86‐0) is one of the active substances listed in that Regulation.

In accordance with Article 1 of Regulation (EU) No 844/2012, the rapporteur Member State (RMS), Greece, and co‐rapporteur Member State (co‐RMS), France, received an application from TotalEnergies Fluids S.A.S./Certis Europe B.V. for the renewal of approval of the active substance paraffin oil (CAS 72623‐86‐0).

An initial evaluation of the dossier on paraffin oil (CAS 72623‐86‐0) was provided by the RMS in the renewal assessment report (RAR) and subsequently, a peer review of the pesticide risk assessment on the RMS evaluation was conducted by EFSA in accordance with Article 13 of Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The following conclusions are derived.

The uses of paraffin oil (CAS 72623‐86‐0) according to the representative uses as an insecticide on seed potatoes as proposed at EU level result in a sufficient efficacy against the target pests.

The assessment of the data package revealed no issues that could not be finalised or that need to be included as critical areas of concern with respect to identity, physical–chemical and technical properties of the active substance and the formulation for representative uses and analytical methods.

In the area of mammalian toxicology and non‐dietary exposure, the active substance is considered of low toxicity based on the available information. No critical areas of concern or issues that could not be finalised were identified.

A consumer's risk assessment is not required for the paraffin oil under assessment considering the toxicological profile of the paraffin oil. With respect to the Polycyclic Aromatic Hydrocarbons (PAHs) impurities, information on the actual concentration data for PAHs in paraffin oil is not available.

In the area of environmental fate and behaviour, the available information was considered sufficient to complete the necessary environmental exposure assessments.

In the area of ecotoxicology, low risk to birds and mammals, soil microorganisms, non‐target terrestrial plants and organisms involved in biological methods for sewage treatment was concluded for all the representative uses. High risk to earthworms and other soil meso and macrofauna and was indicated for some of the representative uses. A critical area of concern was identified for the aquatic organisms. The risk assessment to non‐target arthropods (only for the uses with multiple applications) and bees could not be finalised.

The active substance paraffin oil CAS 72623‐86‐0 is unlikely to meet the criteria for endocrine disruption for humans and non‐target organisms according to points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605.

BACKGROUND

Commission Implementing Regulation (EU) No 844/2012,1 as amended by Commission Implementing Regulation (EU) No 2018/1659,2 (hereinafter referred to as ‘the Regulation’) lays down the provisions for the procedure of the renewal of the approval of active substances submitted under Article 14 of Regulation (EC) No 1107/2009.3 This regulates for the European Food Safety Authority (EFSA) the procedure for organising the consultation of Member States, the applicant(s) and the public on the initial evaluation provided by the rapporteur Member State (RMS) and/or co‐rapporteur Member State (co‐RMS) in the renewal assessment report (RAR) and the organisation of an expert consultation where appropriate.

In accordance with Article 13 of the Regulation, unless formally informed by the European Commission that a conclusion is not necessary, EFSA is required to adopt a conclusion on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 within 5 months from the end of the period provided for the submission of written comments, subject to an extension of an additional 3 months where additional information is required to be submitted by the applicant(s) in accordance with Article 13(3). Furthermore, in accordance with Article 13(3a), where the information available in the dossier is not sufficient to conclude the assessment on whether the approval criteria for endocrine disruption are met, additional information can be requested to be submitted in a minimum period of 3 months, not exceeding 30 months, depending on the type of information requested.

In accordance with Article 1 of the Regulation, the RMS, Greece, and co‐RMS, France, received an application from TotalEnergies Fluids S.A.S./Certis Europe B.V. for the renewal of approval of the active substance paraffin oil (CAS 72623‐86‐0). Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the co‐RMS France, the European Commission and EFSA about the admissibility.

The RMS provided its initial evaluation of the dossier on paraffin oil (CAS 72623‐86‐0) in the RAR, which was received by EFSA on 21 December 2021 and then updated in January 2023 (Greece, 2023).

In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, TotalEnergies Fluids S.A.S./Certis Europe B.V., for consultation and comments on 10 October 2023. EFSA also provided comments. In addition, EFSA conducted a public consultation on the RAR. EFSA collated and forwarded all comments received to the European Commission on 13 December 2023. At the same time, the collated comments were forwarded to the RMS for compilation and evaluation in the format of reporting table. In addition, the applicants were invited to respond to the comments received. The comments and the applicants' response were evaluated by the RMS in column 3.

The need for expert consultation and the necessity for additional information to be submitted by the applicants in accordance with Article 13(3) of the Regulation were considered via a written procedure between EFSA and the RMS on 22 May 2024. On the basis of the comments received, the applicants' response to the comments and the RMS's evaluation thereof, it was concluded that additional information should be requested from the applicants and that EFSA should conduct an expert consultation in the areas of mammalian toxicology, environmental fate and behaviour and ecotoxicology.

The outcome of the written procedure, together with EFSA's further consideration of the comments, is reflected in the conclusions set out in column 4 of the reporting table. All points that were identified as unresolved at the end of the comment evaluation phase and which required further consideration, including those issues to be considered in an expert consultation, were compiled by EFSA in the format of an evaluation table.

The conclusions arising from the consideration by EFSA, and as appropriate by the RMS, of the points identified in the evaluation table, together with the outcome of the expert consultation and the written consultation on the assessment of additional information, where these took place, were reported in the final column of the evaluation table.

A final consultation on the conclusions arising from the peer review of the risk assessment took place with Member States via a written procedure in October 2025.

This conclusion report summarises the outcome of the peer review of the risk assessment of the active substance and the formulations for representative uses, evaluated on the basis of the representative uses of paraffin oil (CAS 72623‐86‐0) as an acaricide, insecticide and fungicide on seed potatoes, as proposed by the applicants. In accordance with Article 12(2) of Regulation (EC) No 1107/2009, risk mitigation options identified in the RAR and considered during the peer review, if any, are presented in the conclusion.

A list of the relevant end points for the active substance and the formulation provided in Appendix B. In addition, the considerations as regards the cut‐off criteria for paraffin oil (CAS 72623‐86‐0) according to Annex II of Regulation (EC) No 1107/2009 are summarised in Appendix A.

A key supporting document to this conclusion is the Peer Review Report (EFSA, 2025), which is a compilation of the documentation developed to evaluate and address all issues raised in the peer review, from the initial commenting phase to the conclusion. The peer review report comprises the following documents, in which all views expressed during the course of the peer review, including minority views, where applicable, can be found:

• the comments received on the RAR;
• the reporting table (23 May 2024);
• the evaluation table (4 November 2025);
• the reports of the scientific consultation with Member State experts (where relevant);
• the comments received on the assessment of the additional information (where relevant);
• the comments received on the draft EFSA conclusion.

Given the importance of the RAR, including its revisions (Greece, 2025), and the Peer Review Report, both documents are considered as background documents to this conclusion and thus are made publicly available.

It is recommended that this conclusion and its background documents would not be accepted to support any registration outside the EU for which the applicant has not demonstrated that it has regulatory access to the information on which this conclusion report is based.

THE ACTIVE SUBSTANCE AND THE FORMULATIONS FOR REPRESENTATIVE USES

The active substance for risk assessment is paraffin oil (CAS 72623‐86‐0).4 There is no ISO common name for this substance. The name used in the European Pharmacopoeia 6.0 is paraffin liquid, Paraffinum liquidum. The active substance is a mixture of saturated hydrocarbons having carbon numbers predominantly in the range of C_19_–C_28_.

The formulations for representative uses supported for the evaluation were ‘FINAVESTAN EMA’ an emulsifiable concentrate (EC) containing 807 g/L of pure paraffin oil (CAS 72623‐86‐0) and ‘OLIE‐H’ an emulsifiable concentrate (EC) containing 794 g/L of pure paraffin oil (CAS 72623‐86‐0).

The information on the active substance and the formulations for representative uses, including the co‐formulants in these formulations, was considered in the overall assessment during the peer review. One of the components of a co‐formulant is an unacceptable co‐formulant listed in Annex III of Regulation (EC) No 1107/20095 and one of the components of a co‐formulant in 'OLIE‐H'6 is a non‐approved active substance under Regulation (EC) No 1107/2009.

Details on the composition of the formulations cannot be reported in conclusions because of the provisions in Article 63(2)(d) of Regulation (EC) No 1107/2009; however, this information was fully available and evaluated during the peer review. A proposal for classification of the formulations according to Regulation (EC) 1272/2008 was provided by the applicant and assessed by the RMS (please see Volumes 3 CP of the RAR).

Data gaps were set for information on the composition of a co‐formulant contained in ‘FINAVESTAN EMA’ and for a co‐formulant contained in ‘OLIE‐H’ (see Section 10).

The representative uses evaluated for the renewal for both formulations were spray application, as insecticide, on potato seed crops using vehicle‐mounted sprayer against aphids as vectors of non‐persistent viruses. Full details of the good agricultural practice (GAP) can be found in the list of end points in Appendix B. Data were submitted to conclude that the use of paraffin oil (CAS 72623‐86‐0) according to the representative uses proposed at EU level results in a sufficient insecticide efficacy against the target pests, following the guidance document SANCO/2012/11251‐rev. 4 (European Commission, 2014b).

CONCLUSIONS OF THE EVALUATION

General aspects

With regard to the mammalian toxicity information available for the formulations for representative uses ‘FINAVESTAN EMA’ and ‘OLIE‐H’, studies were performed for acute toxicity endpoints.

With regard to the co‐formulants contained in ‘FINAVESTAN EMA’, sufficient toxicological data were available for all of the components, but one (present below 10% in the formulation). For this co‐formulant, the available toxicological information did not sufficiently address the genotoxicity and repeated‐dose toxicity potential of ‘FINAVESTAN EMA’ over the short and long term, and thus, it might be considered for further assessment. The collected information (not covering all endpoints), including information from the existing uses other than plant protection products, under regulated EU frameworks, did not highlight any concern (see Section 10). One component of a co‐formulant listed in Annex III (present below 10% in the formulation) has a harmonised classification as Carcinogenic 1B, Reproductive toxicity 1B, STOT RE 1 (nervous system), STOT SE 3 (H335, H336) and Mutagenic 1B.

With regard to the co‐formulants contained in ‘OLIE‐H’, sufficient toxicological data were available for all of the components, but one (present below 10% in the formulation). For this co‐formulant, information on the composition of a co‐formulant was not available (data gap, see Section 10). With the exception of this co‐formulant, EFSA considered that the available toxicological information did sufficiently address the genotoxicity and repeated dose toxicity potential of ‘OLIE‐H’ over the short and long term, and no concern was identified.

The availability of ecotoxicity data with the formulations for representative uses was discussed at the experts' meeting7 (refer to Section 5). A data retrieval search for available ecotoxicity data for the individual components was not available for the formulation Finavestan EMA. Therefore, it was not possible to reach a conclusion on the safety of Finavestan EMA for certain groups of non‐target organisms for which data with that formulation were not available (data gap, see Section 10). No concerns were identified for the safety of the formulation OLIE‐H.

A data gap has been identified for a comprehensive and transparently reported search of the scientific peer‐reviewed open literature on the active substance and its relevant metabolites, dealing with side effects on consumer health and the environment and published within the 10 years before the date of submission of the dossier, to be conducted and reported in accordance with EFSA guidance on the submission of scientific peer‐reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009 (EFSA, 2011).

IDENTITY, PHYSICAL/CHEMICAL/TECHNICAL PROPERTIES AND METHODS OF ANALYSIS

1

The following guidance documents were followed in the production of this conclusion: European Commission (2000, 2010, 2019).

The proposed specification for paraffin oil (CAS 72623‐86‐0) is based on batch data from industrial scale production. The submitted batch data complied with the criteria of the European Pharmacopoeia 6.0 for paraffin liquid – Paraffinum liquidum, except for the criterion of density and viscosity. The applicants and RMS proposed to maintain the current reference specification of the European Pharmacopoeia 6.0 for paraffin, liquid – Paraffinum liquidum. The toxicological assessment concluded that polycyclic aromatic hydrocarbons (PAHs) are relevant impurities with a maximum sum content of 0.3 mg/kg (see Section 2). It is noted that a numerical threshold value for PAH content is not reported in the European Pharmacopoeia 6.0 specifications. Benzene was also considered a relevant impurity with a maximum level of 0.001% mass (see Section 2). The analytical methods used for the analysis of the impurities in the technical active substance, including the relevant impurities PAHs, were not validated according to SANCO/3030/99 rev. 5 (European Commission, 2019).8 Thus, the compliance of the technical active substance with the proposed PAHs levels of 0.3 mg/kg could not be demonstrated (data gap, see Section 10), and a data gap is set for batch data analysed for impurities using validated analytical methods (data gap, see Section 10).9 In addition, specificity data were missing for the analytical method used for the determination of benzene in the technical active substance (data gap, see Section 10). It is proposed to update the reference specification from the first approval (i.e. European Pharmacopoeia 6.0 for paraffin, liquid Paraffinum liquidum) with the minimum purity of 1000 g/kg and PAHs and benzene as relevant impurities specified at a maximum level of 0.3 mg/kg and 0.001% mass, respectively. There is no FAO specification available for paraffin oil (CAS 72623‐86‐0). The (eco)toxicological assessment supports the current and proposed specification (see Sections 2 and 5).

The main data regarding the identity of paraffin oil (CAS 72623‐86‐0) and its physical and chemical properties are given in Appendix B. Non‐Good Laboratory Practice (GLP); slower when the n‐alkanes are branched or cyclic. data were provided for the endpoints of self‐heating, flash point and surface tension of the active substance, which were accepted by the RMS. However, as these endpoints are relevant to the safety properties of the active substance, EFSA set a data gap (see Section 10). No data were provided on the solubility of the active substance in halogenated hydrocarbons (data gap, see Section 10). Data gaps were set for the explosive and oxidising properties, flash point, auto‐ignition, surface tension, viscosity, density and shelf‐life stability of the formulation ‘Finavestan EMA’ (see Section 10).10

In general, adequate methods were available for the generation of data required for the risk assessment except for some ecotoxicological studies (data gap, see Section 10). Appropriate methods of analysis were available for the determination of paraffin oil (CAS 72623‐86‐0) in the technical active substance and the formulations for representative uses. Analytical methods for monitoring the relevant impurities PAHs in the active substance and the formulations for representative uses were not provided (data gap, see Section 10).

Monitoring methods for food and feed of plant and animal origin are not required since no residue definitions were set (See Section 3). Paraffin oil (CAS 72623‐86‐0) residues in soil can be monitored with a GC‐MS method with a limit of quantification (LOQ) of 1.6 mg/kg. Data gaps were identified for appropriate methods for monitoring paraffin oil (CAS 72623‐86‐0) in surface water, air, body fluids and tissues (data gap, see Section 10).

MAMMALIAN TOXICITY

2

The toxicological profile of the active substance paraffin oil (CAS 72623‐86‐0) was discussed at the Pesticides Peer Review Experts' Teleconference (TC) 152 and 153 in November 2024.

The assessment is based on the following guidance documents: EFSA (2014, 2017), EFSA Scientific Committee (2011), EFSA Technical Report (2020), European Commission (2014b).

The current reference specification of the European Pharmacopoeia 6.0 for paraffin, liquid, Paraffinum liquidum is proposed (see Section 1). PAHs are relevant impurities in paraffin oils due to their genotoxic and carcinogenic properties11 of no concern at the proposed level of 0.3 mg PAHs/kg. EFSA identified benzene as a relevant impurity; but it is not considered of toxicological concern at the maximum level of 0.001%. However, it is noted that the available batch analytical data to support these proposed maximum levels of PAHs and benzene were not generated using analytical methods that were validated according to SANCO/3030/99 rev. 5 (see Section 1).

The regulatory data set available for paraffin oil (CAS 72623‐86‐0) was limited. Regulatory toxicity studies are only available on paraffin oil (CAS 72623‐86‐0) for acute toxicity (oral and dermal toxicity studies in rats, skin and eye irritation studies in rabbits and a skin sensitisation study in guinea pigs). A regulatory acute oral toxicity and an in vitro genotoxicity study (Ames test) were available for paraffin oil (CAS 64742‐46‐7), which was considered a relevant surrogate for paraffin oil (CAS 72623‐86‐0).

Given the lack of regulatory studies for paraffin oil (CAS 64742‐46‐7/72623‐86‐0) for toxicological endpoints other than acute toxicity, skin/eye irritation and skin sensitisation (no regulatory studies at all for CAS 97862‐82‐3), a weight‐of‐evidence toxicological assessment was carried out for the other toxicological endpoints, based on publicly available scientific publications and study reports on test materials consisting mainly of Mineral Oil Saturated Hydrocarbons (MOSH) and other substances considered appropriate surrogates.12 In addition, the long‐term use of highly purified white mineral oils in medicine, cosmetics and food has been considered (BfR, 2018; EFSA CONTAM Panel, 2012, 2023; EMEA, 1995). The oral absorption of MOSH in rats is estimated to account for 25% of the administered dose (based on absorption data of low doses of C_26_–C_29_ n‐alkanes and cycloalkanes, which are considered a representative surrogate for this active substance).13 Excretion occurs predominantly through the faecal route and secondly via urine. In the rat, relatively high MOSH levels have been reported in the liver, mesenteric lymph nodes, spleen and fat. Accumulation can occur in these organs and tissues and it is similarly described also in humans. Cytochrome P450 enzymes are considered to play an important role in the biotransformation of paraffin oils, transforming alkanes into alcohols and then into the corresponding fatty acids, some of which follow the normal β‐oxidation pathway; slower when the n‐alkanes are branched or cyclic.

ADME studies on MOSH in the rat demonstrated a notable difference in the toxicokinetics between rat strains, with Fischer‐344 (F‐344) showing higher bioavailability and accumulation potential as compared to Sprague Dawley (SD) rats. In vitro studies on hepatic microsomes suggest a similar metabolism of alkanes in various strains of rats and in humans.

Based on the regulatory studies available for Paraffin oil (CAS 64742‐46‐7/72623‐86‐0), paraffin oil (CAS 72623‐86‐0) was concluded to have low acute toxicity by oral, dermal and inhalation exposure, and to be neither skin or eye irritant, nor skin sensitiser. Testing for photo(geno)toxicity is not required as the active substance does not significantly absorb electromagnetic radiation in the range of 290–700 nm, as it would be required according to Regulation (EC) 283/2013.

In short‐term oral toxicity studies on MOSH, liver (micro)granulomas associated with necrotic cells, inflammatory (lymphocytic) infiltration and fibrosis were identified as treatment‐related adverse effects in F‐344 rats. A no observed adverse effect level (NOAEL) of 22 mg/kg body weight (bw) per day was set in F‐344 female rats on the basis of a 90‐day study, related to such findings observed at 222 mg/kg bw.14 No adverse findings were seen in other rat strains, nor in the dog.15 Although the accumulation of mineral oils is known to occur in the liver of humans following dietary intake, this is not associated with adverse histological findings, rather to lipogranulomas without relevant inflammatory component, largely asymptomatic, not progressing over years and not associated with abnormalities of clinical relevance (EFSA, 2024; EFSA CONTAM Panel, 2023). In a short‐term inhalation toxicity study in SD rats, inhaled MOSH induced accumulation of foamy macrophages in the alveoli associated with a concentration‐dependent increase in lung weight. The adversity of these findings was considered questionable, as it may be attributed to oil deposition and it may be part of a normal physiological process to clear the pulmonary tissues from foreign bodies such as lipid droplets or dust particles, and therefore, the top dose (1000 mg/m^3^) can be considered the no observed adverse effect concentration (NOAEC). It is noted that, for paraffin oil (CAS 8042‐47‐5), another short‐term inhalation study is available and an NOAEC of 500 mg/m^3^ was derived based on increased severity and diffuse distribution of alveolar macrophages and multifocal pneumonia observed at 1500 mg/m^3^ (EFSA, 2024). Furthermore, for paraffin oil (CAS 8042‐47‐5), a 13‐week dermal exposure study in SD rats was available for which the lowest observable adverse effect level (LOAEL) for dermal local effects was set at 75 mg/kg bw per day based on skin irritation (EFSA, 2024).

The genotoxicity was evaluated in a weight of evidence assessment considering a negative Ames test with paraffin oil (CAS 64742‐46‐7), a negative reported in vivo mammalian erythrocyte micronucleus test for the REACH registration of paraffin oil (CAS 8042‐47‐5) (not assessed by any authority; no proof of bone marrow exposure16), data retrieved from studies from open literature with surrogate substances, reported assessments previously carried out by different regulatory bodies (BfR, 2017) and conclusions from the EFSA CONTAM Panel (2012, 2023).17 Based on the available information, it was concluded that the substance is considered unlikely to be genotoxic and that no further testing is needed.18

After long‐term exposure via the oral route, no MOSH‐related chronic toxicity was identified in rats and the relevant oral NOAEL is 1941/2291 mg/kg body weight (bw) per day based on a 2‐year oral study on F‐344 rats (the highest dose level tested, in males and females, respectively). Following long‐term exposure via inhalation (in SD rat, mouse, gerbil and dog), the lung was identified as the target organ for chronic toxicity in SD rats and dogs, with the relevant NOAEC set at 5 mg/m^3^ in both species based on lung microgranulomas observed at a respirable aerosol concentration of 100 mg/m^3^.

No MOSH treatment‐related tumours were seen after long‐term exposure in rats, and the relevant oral NOAEL for carcinogenicity is 1941/2291 mg/kg bw per day based on the 2‐year oral study in F‐344 rats (the highest dose level tested, in males and females, respectively). Although no long‐term carcinogenicity study on MOSH by oral route in mice was provided, a waiver of the (oral) carcinogenicity study in mouse is considered acceptable, based on

• the absence of MOSH long‐term toxicity/carcinogenicity in rats (via oral and inhalation routes) and mice (via dermal and inhalation routes),
• no evidence of cancer in humans despite the long‐term use of highly purified white mineral oils in medicine and cosmetics,
• the negative human epidemiology study on kerosene and
• the absence of reported adverse effects with use of highly refined mineral oils as placebos in human studies.19

Based on the available information, the substance was concluded unlikely to be carcinogenic in humans.20

As regards reproductive toxicity, a reproduction/developmental toxicity screening test via the dermal route was available with paraffin oil (CAS 8042‐47‐5). No effects on reproductive parameters, parental systemic toxicity or development of pups were observed in that study, but it was considered of limited relevance, given the low dermal absorption of paraffin oils. Based on the publicly available robust study summaries (as submitted by the registrants) from the REACH registration dossiers on surrogates,21 paraffin oil (CAS 72623‐86‐0) is considered of no concern for reproductive toxicity. No developmental toxicity studies were available, but waiving of such study is considered acceptable, given that there is no evidence of adversity on reproductive organs in any study in the overall available data set and given that mineral white oils have been used extensively as solvent controls in teratogenicity studies in the context of veterinary medicinal product assessment, causing no teratogenic effects. It was concluded that, based on available information on paraffin oils, developmental effects of paraffin oils are unlikely.22 Further assessment of reproductive and developmental toxicity is not needed, given the low toxicological profile of the substance.

The substance was concluded unlikely to be neurotoxic or immunotoxic in humans based on the lack of neurotoxicity or immunotoxicity findings in toxicity studies with MOSH via oral, dermal and inhalation routes of exposure and considering that no clinical and epidemiological evidence of adverse health effects of paraffin oil used in medicine and cosmetics is known. In addition, there is no structural similarity of paraffin oil to substances known for inducing neurotoxicity.

Based on the available information, it was agreed that an acceptable daily intake (ADI) and an acute reference dose (ARfD) are not triggered based on the low toxicity of paraffin oil (CAS 72623‐86‐0) in mammals. On the same basis, the derivation of acute acceptable operator exposure level (AAOEL) and acceptable operator exposure level (AOEL) was not considered necessary. Considering local adverse effects in the lungs following long‐term inhalation exposure to MOSH, which formed the basis to set a MAK value (i.e. from German standing for Maximum Workplace Concentration = MCW) of 5 mg/m^3^ by the German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area for pharmaceutical white mineral oil,23 an acceptable operator exposure concentration (AOEC) was agreed at 5 mg/m^3^.24

Based on the EFSA models (EFSA, 2014, 2022), the non‐dietary inhalative exposure estimates for the operators, workers, residents and bystanders are below the AOEC for all representative uses of the two products.

RESIDUES

3

The assessment in the residue section is based on the following guidance documents: OECD (2009, 2011), European Commission (2011) and JMPR (2004, 2007).

Paraffin oil (CAS 72623‐86‐0) is proposed for use as an insecticide on seed potatoes. Residue data and studies with this paraffin oil have not been provided by the applicant since paraffin oils have been included in Annex IV of Regulation (EC) No 396/2005. The applicant claimed that this paraffin oil complies with the European Pharmacopoeia 6.0 with respect to the levels of polycyclic aromatic hydrocarbons (PAHs). However, the available batch analytical data to support such a claim were not generated using an analytical method validated according to SANCO/3030/99 rev.5 (see Section 1). Accordingly, the compliance of the technical active substance with the proposed PAHs levels could not be demonstrated (see data gap in Sections 1 and 10). The proposed amount of the relevant impurity PAHs is of no concern.

With regard to the five assessment criteria according to the Commission guidance SANCO/11188/2013 Rev. 2 (European Commission, 2015) for potential inclusion in Annex IV of Regulation (EC) No 396/2005, i.e. approval as basic substance (criterion I), listed in Annex I of Regulation (EC) No 396/2005 (criterion II), having no identified hazardous properties (criterion III), natural exposure is higher than the one linked to the use as plant protection product (criterion IV) and consumer exposure is not expected considering the representative uses (criterion V), only criterion III is fulfilled provided that valid analytical data for polycyclic aromatic hydrocarbons (PAHs) are submitted; their proposed level is of no concern. Criteria I and II are not met; criterion IV is not relevant as paraffin oil is not occurring naturally. Criterion V is not met as residue data are not provided to prove that the spray application of this paraffin oil to seed potatoes until growth stage BBCH 99 will not result in consumer exposure, but it is not relevant as no toxicological reference values have been set for paraffin oil.

ENVIRONMENTAL FATE AND BEHAVIOUR

4

Paraffin oil (CAS 72623‐86‐0) was discussed at the Pesticides Peer Review Meeting Teleconference (TC) 154 in November 2024. The environmental exposure assessment was conducted using a lead component approach, based on carbon chain length rather than relative abundance in the mixture.

The rates of dissipation and degradation in the investigated environmental matrices were estimated using FOCUS (2006) kinetics guidance. In soil laboratory incubations under aerobic conditions in the dark, paraffin oil (CAS 72623‐86‐0) exhibited moderate to high persistence. No major metabolites (> 10% applied test item) were formed. Being paraffin oil (CAS 72623‐86‐0) a mixture of several hydrocarbons, i.e. n‐alkanes, iso‐alkanes and cycloalkanes with chain lengths in the range C_19_‐C_28_, the expected transformation products would be alkanes with shorter carbon chains leading to a complete mineralisation to carbon dioxide as the final product. Anaerobic soil incubation studies were not considered necessary based on the representative uses on seed potatoes, while photodegradation does not play a role in the degradation of paraffin oils in soil. Paraffin oil (CAS 72623‐86‐0) exhibited immobility in soil estimated deriving adsorption parameters using quantitative structure–activity relationship (QSAR) software KOCWIN v2.00. Adsorption endpoints corresponding to the lowest carbon chain of the paraffin oil mixture (C_19_) were considered by the peer review the most appropriate to ensure a reliable assessment. This is also confirmed by the very low solubility in water and the high lipophilic nature of the C‐chains of the alkanes that formed the mixture C_19_–C_28_. Although field dissipation studies are triggered, based on results from soil laboratory incubations under aerobic conditions in the dark, they are not expected to provide relevant information because of the natural and anthropogenic occurrence of alkanes in the different environmental compartments, including soil. However, scientific evidence was not available to demonstrate that the amounts of the components of paraffin oil (CAS 72623‐86‐0) introduced into the soil from its representative uses will not exceed the natural background concentrations of these components (data gap, see Section 10 acknowledging that natural background concentration information is difficult to obtain).

In the absence of a reliable ready biodegradability study (data gap, see Section 10), paraffin oil (CAS 72623‐86‐0) is considered as not readily biodegradable. In the aquatic compartments, paraffin oil (CAS 72623‐86‐0) is expected to degrade in alkanes with shorter carbon chains, ultimately leading to complete mineralisation into carbon dioxide. However, data on the natural background concentrations of paraffin oil (CAS 72623‐86‐0) components in the aquatic compartment are not available (data gap, see Section 10). As a result, it is unknown whether residues resulting from its representative uses could exceed the natural background levels, especially in sediment. Due to the physical properties of paraffin oil (CAS 72623‐86‐0) (i.e. high adsorption properties and very slight solubility in water also in the presence of emulsifiers), water/sediment studies following the OECD TG 308 (OECD, 2002) may not be feasible and modified study designs might be necessary. Nevertheless, the peer review agreed that further information is needed to address the rate of degradation of paraffin oil (CAS 72623‐86‐0) in the aquatic environment, especially in the sediment compartment, for potential exposure refinement and in case such data are necessary for additional evaluation at national level (data gap, see Section 10). The surface water and sediment exposure assessments (Predicted Environmental Concentrations (PEC)) calculations were then carried out for paraffin oil (CAS 72623‐86‐0) using the FOCUS (FOCUS, 2001) Step 1 and Step 2 approach (version 3.2 of the Steps 1–2 in FOCUS calculator). Due to the above considerations on physico‐chemical properties and the physical mode of action of paraffin oil CAS 72623‐86‐0, Step 3 (and subsequent steps) calculations were deemed not appropriate because of the instantaneous partitioning to sediment considered in the model TOXSWA. Step 2 calculations, with a drift‐only scenario, do not consider instantaneous partitioning to the sediment and therefore were considered more appropriate. To refine the PEC_sw_ and PEC_sed_ calculations, in line with previous evaluations of similar substances, two relevant exposure scenarios were considered: PEC_sw_ and PEC_sed_ calculated as concentration and assuming the distribution of oil droplets throughout the water column (PEC 3D approach), and PEC_sw_ calculated as deposition area assuming the formation of a film of the substance at the water surface (PEC 2D approach). Step 2 calculations were based on worst‐case default values and incorporated spray drift mitigation measures (i.e. non‐spray buffer zone + drift reduction nozzles) applied directly to Step 2. Although arithmetically correct PEC_sw_ values that have drift mitigation greater than 95% (combining buffer zones and nozzles) are available in the RAR, they were not relied on for this conclusion (and have not been included in Appendix B), as their use would contravene the applicable FOCUS (2007) guidance endorsed for use in EU level assessment.

The necessary groundwater exposure assessments were appropriately carried out using FOCUS (European Commission, 2014a) scenarios and the models PEARL 5.5.5, PELMO 6.6.4 and MACRO 5.5.4.25 The potential for groundwater exposure from the representative uses by paraffin oil (CAS 72623‐86‐0) above the parametric drinking water limit of 0.1 μg/L, calculated using the endpoints agreed by the experts during the TC 154,26 was concluded to be low for both FINAVESTAN EMA and OLIE‐H representative formulations, in geoclimatic situations that are represented by all nine FOCUS groundwater scenarios.

The applicant provided sufficient information to address the effect of water treatment processes on the nature of the residues that might be present in surface water and groundwater, when surface water and groundwater are abstracted for the production of drinking water. The conclusion of this consideration was that paraffin oil (CAS 72623‐86‐0) would not be expected to undergo any substantial transformation due to oxidation/chlorination at the disinfection stage of water treatment processes, as n‐alkanes are chemically inert under the controlled conditions which are usually provided for such types of treatments. Moreover, the physical–chemical properties of alkanes suggested that physical water treatment processes like clarification (coagulation, flocculation), sieving and filtration, normally conducted before any disinfection step, appear effective in retaining the possible fractions of paraffin oil (CAS 72623‐86‐0) that could reach a water treatment plant.

The PEC in soil, surface water, sediment and groundwater covering the representative uses assessed can be found in Appendix B of this conclusion. A key to the wording used to describe the persistence and mobility of the compounds assessed can be found in Appendix C of this conclusion.

ECOTOXICOLOGY

5

The risk assessment was based on the following documents: European Commission (2002), SETAC (2001), EFSA (2009, 2013) and EFSA PPR Panel (2013).

The risk assessment was discussed at the Pesticides Peer Review Experts' Teleconference 155 (December 2024).

The (eco)toxicological assessment supports the current and proposed specification.

The analytical method used in several ecotoxicity studies of paraffin oil (CAS 72623‐86‐0) was not considered acceptable (data gap; see Sections 1 and 10).

The ecotoxicological equivalence of several paraffin oil‐based formulations was discussed during the Pesticides Peer Review Experts' teleconference, specifically Finavestan EMA and Olie‐H (both containing paraffin oil (CAS 72623‐86‐0)) as well as Citrole and Ovispray (both containing paraffin oil (CAS 64742‐46‐7)). Based on their composition, all experts agreed that Finavestan EMA, Olie‐H, Citrole and Ovispray could be considered comparable. Consequently, a read‐across approach for these formulations was accepted.27

Toxicity studies with the active substance or the formulations for the representative uses Finavestan EMA and Olie‐H were not available for birds and wild mammals; therefore, no quantitative risk assessments were performed. However, considering other available information, including (i) the long history of safe use of paraffin oils as adjuvants in veterinary vaccines and other medicinal applications across a wide range of vertebrate species, including birds and mammals; (ii) the fact that paraffin oils are chemically inert substances with no toxophore and have been widely used as non‐invasive biomarkers in ecological studies precisely because of their inertness; and (iii) the ubiquitous presence of paraffin oil components in the environment, including in plant cuticle waxes, vegetable oils and arthropod cuticles, leading to continuous lifetime exposure through diet without adverse effects, it was concluded that the acute and long‐term risks to birds and wild mammals from all representative uses of paraffin oils are low for all possible exposure scenarios.

The available data package for a quantitative risk assessment of paraffin oil (CAS 72623‐86‐0) on aquatic organisms consisted of two outdoor studies with the aquatic invertebrates Culex sp. and Notonocta sp., an algal study (all conducted with Olie‐H) and a study with the sediment‐dwelling organism Chironomus riparius using Citrole. The endpoint selection from the outdoor studies was agreed by the experts.28 A Daphnia reproduction study using Finavestan EMA was also available, but the experts considered that no endpoint could be established for quantitative risk assessment as quantifiable concentrations were only observed for the highest concentration at most time points, with limited data for lower concentrations.^9^ Several other studies were available using a water‐accommodated fraction (WAF). The experts agreed that endpoints obtained via WAF should not be used in a quantitative risk assessment as the WAF approach results in an underestimation of toxicity endpoints, but could be considered qualitatively as supporting evidence in a weight of evidence (WoE) approach.^9^

A mesocosm study conducted in artificial streams with Citrole was also available. However, based on identified limitations and drawbacks that affected the study's relevance, reliability and representativeness, the experts concluded that the mesocosm study could not be used in a quantitative risk assessment and that no regulatory endpoints could be derived.29

The risk assessment for fish was conducted using a WoE approach based on several key arguments.30 Firstly, all available fish studies, conducted with WAF, were deemed unsuitable for a quantitative risk assessment. However, these studies showed no toxic effects, and fish are unlikely to be sensitive to paraffin oil's mode of action, which involves a physical film on the water surface. Additionally, previous assessments of paraffin oils (EFSA, 2024) raised no toxicity concerns for fish. Considering these factors, along with the aim to minimise vertebrate testing, the experts unanimously agreed that the WoE approach was appropriate and concluded that paraffin oil (CAS 72623‐86‐0) poses a low acute and chronic risk to fish for all representative uses.

A quantitative risk assessment was presented for aquatic invertebrates, algae and sediment‐dwelling organisms. The proposal to reduce the default assessment factors was not accepted by the experts, as the applicant did not provide a robust justification.31 The risk assessment indicated:

• – Aquatic invertebrates: A high acute risk at FOCUS Step_sw_ 2 for all representative uses (critical area of concern; see Section 9.2).
• – Algae: A low risk at FOCUS Step_sw_ 1 for all representative uses.
• – Sediment‐dwelling organisms: A low risk at FOCUS Step_sw_ 2 for single and multiple applications at 5 kg a.s./ha (Olie‐H) and at FOCUS Step_sw_ 2, with mitigation measures (Table 5), for single and multiple applications in potatoes at 9.68 kg a.s./ha (uses with Finavestan EMA).

A chronic risk assessment to aquatic invertebrates was not available due to the lack of suitable data (data gap leading to an issue that could not be finalised; see Section 9.1).

No relevant metabolites were identified for paraffin oil (CAS 72623‐86‐0) in surface water; therefore, a risk assessment for metabolites was not required.

Suitable acute toxicity data (both contact and oral) for honey bees were available with Ovispray, a formulation comparable to those used for the representative uses of paraffin oil (CAS 72623‐86‐0). Additionally, a semi‐field (tunnel) study was conducted. The validity of this study and its applicability in the risk assessment were discussed during the meeting. The experts agreed that the semi‐field study could account for potential contact effects resulting from overspray following the application of paraffin oil (CAS 72623‐86‐0).

Based on European Commission (2002) guidance, a low acute risk was indicated for both contact and oral exposure. Similarly, according to EFSA (2013) guidance, a low risk from both contact and oral exposure was concluded at the screening step.

Chronic toxicity data for both adult bees and larvae were not available. Moreover, the chronic risk to honey bee larvae could not be adequately assessed using the semi‐field study. Most experts agreed that the patterns of effects and the variability across treatments made the biological significance of the observed effects debatable. However, the majority of experts concluded that the study results were insufficient to rule out a high risk to larvae from paraffin oil application. Consequently, a data gap was identified to assess the chronic risk to both bee larvae and adults leading to an issue that could not be finalised (see Section 9.1).

Specific assessments for accumulative effects were unavailable. No toxicity data were available for bumble bees or solitary bees. No relevant metabolites were identified for paraffin oil (CAS 72623‐86‐0) in pollen and nectar; therefore, a risk assessment for metabolites was not required.

To assess the risk to non‐target arthropods other than bees, the following studies were available: extended laboratory studies with the standard species Aphidius rhopalosiphi, as well as Chrysoperla carnea and Orius laevigatus for Finavestan EMA/DEV 2008‐13. Additionally, an extended laboratory study was conducted with Coccinella septempunctata for Olie‐H. An aged‐residue study was also available with the standard species Typhlodromus pyri for Olie‐H. No Tier 1 (glass plate) studies were available for any of the standard species. The relevance of the aged‐residue study was discussed during the meeting.32 All experts agreed that the study, which involved two applications at 35.7 kg a.s./ha, could be used to demonstrate the recovery potential of paraffin oil under the specific application regime tested. Experts at the meeting agreed that standard tests – where test species are exposed to either fresh or dried residues sprayed on glass plates or plant leaves – may not be adequately designed to assess the potential effects of sprayed insecticides with a physical mode of action, such as paraffin oil.

Furthermore, two field studies on T. pyri, one with Finavestan EMA/DEV 2008‐13 and another with Olie‐H, were available. Both field studies were deemed unreliable and, consequently, were not used to refine the risk assessment.33

Based on the results of the aged‐residue study, a low in‐field risk was concluded for the use of Olie‐H at 2 × 5 kg/ha and for a single application of Finavestan EMA at 9.68 kg/ha on seed potatoes. Low risk could not be concluded for the remaining uses with both formulations (data gap, leading to an issue not finalised, see Section 9.1).

For the off‐field risk assessment, a low risk was concluded for all representative uses of paraffin oil (CAS 72623‐86‐0).34 However, as noted above, standard tests are not adequately designed to assess the potential effects of physically acting substances and may underestimate the risk from exposure via drift. As a result, uncertainty remains in the risk characterisation due to limitations in standard testing methods for off‐field exposure. Should any of the highlighted uncertainties arising from the standard tests be impacting on national registration of products, MSs may consider the need for additional clarifications (data gap; see Section 10).

Chronic toxicity studies were conducted on earthworms (Eisenia fetida) and soil meso‐ and macrofauna, including the collembola Folsomia candida and the predatory mite Hypoaspis aculeifer, using Finavestan EMA. This formulation was considered comparable to Olie‐H. Based on the available data and the results of the Tier 1 risk assessment, a low chronic risk was determined for E. fetida and F. candida across all representative uses of Olie‐H, as well as for single‐application uses of Finavestan EMA. However, for multiple‐application uses of Finavestan EMA, a high risk was indicated for both E. fetida and F. candida. In contrast, H. aculeifer exhibited a low risk across all representative uses for both formulations.

Additionally, studies assessing the effects of Finavestan EMA on soil microorganisms were available. Based on the data, the risk to soil microorganisms was considered low across all representative uses.

No relevant soil metabolites were identified for paraffin oil (CAS 72623‐86‐0); therefore, a risk assessment was not required.

Vegetative vigour and seedling emergence studies with the comparable formulation Ovispray were available to assess the risk to non‐target terrestrial higher plants. Based on the available studies and risk assessment, a low risk was concluded for all representative uses of paraffin oil (CAS 72623‐86‐0).

Low risk to organisms involved in biological methods for sewage treatment could also be concluded for all representative uses.

ENDOCRINE DISRUPTION PROPERTIES

6

The endocrine disrupting properties of paraffin oil (CAS 72623‐86‐0) were discussed at the Pesticides Peer Review Experts' TC 152 in November 2024.35

With regard to the assessment of the endocrine disruption potential of paraffin oil (CAS 72623‐86‐0) for humans and non‐target organisms according to the ECHA/EFSA ED guidance (2018), although a full (eco)toxicological data set was not available to investigate endocrine activity/adversity, this does not appear scientifically necessary and a waiver has been accepted based on the following considerations:

• the nature of paraffin oil is mainly constituted of alkanes, and its expected physical mode of action on non‐target organisms (suffocation and smothering);
• the ubiquitous presence of paraffin oil components in the environment, as a constituent of plants and arthropods' cuticle wax (non‐target organisms);
• the history of safe use of paraffin oil and refined mineral oils as cosmetic ingredient (BfR, 2018), food (EFSA CONTAM Panel, 2012, 2023) and in medicine (EMEA, 1995);
• in the available in vivo studies (from public literature), on representative surrogates of mineral oils, low mammalian toxicity is observed and no human concern is identified by the EFSA CONTAM Panel for MOSH for all age classes (EFSA CONTAM Panel, 2023).
• in the available in vivo studies (from public literature) on representative surrogates of mineral oils, no evidence of lipid accumulation and treatment‐related findings on organs/tissues in the assessed EATS‐mediated parameters are observed;
• there was no concern for endocrine‐mediated activity in the available in silico modelling investigating the EATS modalities.

Based on the available information, it can be concluded that it is unlikely that paraffin oil (CAS 64742‐46‐7) meets the criteria for endocrine disruptors for humans and non‐target organisms according to points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605.

OVERVIEW OF THE RISK ASSESSMENT OF COMPOUNDS LISTED IN RESIDUE DEFINITIONS TRIGGERING ASSESSMENT OF EFFECTS DATA FOR THE ENVIRONMENTAL COMPARTMENTS (TABLES 1, 2, 3, 4)

7

TABLE 2: Groundwater. a

PARTICULAR CONDITIONS PROPOSED TO BE TAKEN INTO ACCOUNT BY RISK MANAGERS

8

Risk mitigation measures (RMMs) identified following consideration of Member State (MS) and/or applicant's proposal(s) during the peer review, if any, are presented in this section. These measures are applicable for human health and/or the environment leading to a reduction of exposure levels of operators, workers, bystanders/residents, environmental compartments and/or non‐target organisms for the representative uses are listed below. The list may also cover any RMMs as appropriate, leading to an acceptable level of risks for the respective non‐target organisms.

It is noted that final decisions on the need of RMMs to ensure the safe use of the plant protection product containing the concerned active substance will be taken by risk managers during the decision‐making phase. Consideration of the validity and appropriateness of the RMMs remains the responsibility of MSs at product authorisation, taking into account their specific agricultural, plant health and environmental conditions at national level.

CONCERNS AND RELATED DATA GAPS

9

Issues that could not be finalised

9.1

An issue is listed as ‘could not be finalised’ if there is not enough information available to perform an assessment, even at the lowest tier level, for one or more of the representative uses in line with the uniform principles in accordance with Article 29(6) of Regulation (EC) No 1107/2009 and as set out in Commission Regulation (EU) No 546/201136 and if the issue is of such importance that it could, when finalised, become a concern (which would also be listed as a critical area of concern if it is of relevance to all representative uses).

An issue is also listed as ‘could not be finalised’ if the available information is considered insufficient to conclude on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

The following issues or assessments that could not be finalised have been identified, together with the reasons including the associated data gaps where relevant, which are reported directly under the specific issue to which they are related:

1. The chronic risk to aquatic invertebrates could not be finalised for any of the representative uses (see Section 5).

• Data were not available to assess the chronic risk to aquatic invertebrates (relevant for all representative uses evaluated, see Section 5).

2. The chronic risk to bee adults and larvae could not be finalised for any of the representative uses (relevant for all representative uses, see Section 5).

• bData were not available to assess the chronic risk to bee adults and larvae (relevant for all representative uses evaluated, see Section 5).

3. The risk to non‐target arthropods other than bees could not be finalised for multiple applications of both formulations for representative uses (see Section 5).

• cSufficient data were not available to assess the in‐field risk to non‐target arthropods (relevant for multiple applications of representative uses evaluated, see Section 5).

Critical areas of concern

9.2

An issue is listed as a critical area of concern if there is enough information available to perform an assessment for the representative uses in line with the uniform principles in accordance with Article 29(6) of Regulation (EC) No 1107/2009 and as set out in Commission Regulation (EU) No 546/2011, and if this assessment does not permit the conclusion that, for at least one of the representative uses, it may be expected that a plant protection product containing the active substance will not have any harmful effect on human or animal health or on groundwater, or any unacceptable influence on the environment.

An issue is also listed as a critical area of concern if the assessment at a higher tier level could not be finalised due to lack of information, and if the assessment performed at the lower tier level does not permit the conclusion that, for at least one of the representative uses, it may be expected that a plant protection product containing the active substance will not have any harmful effect on human or animal health or on groundwater, or any unacceptable influence on the environment.

An issue is also listed as a critical area of concern if, in the light of current scientific and technical knowledge using guidance documents available at the time of application, the active substance is not expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

The following critical areas of concern are identified, together with any associated data gaps, where relevant, which are reported directly under the specific critical area of concern to which they are related:

High acute risk to aquatic invertebrates was identified at FOCUS Step_sw_ 2 for all representative uses (see Section 5).

Overview of the concerns identified for each representative use considered (Table 6)

9.3

If a particular condition proposed to be taken into account to manage an identified risk, as listed in Section 8, has been evaluated as being effective, then ‘risk identified’ is not indicated in Table 6.

LIST OF OTHER OUTSTANDING ISSUES

10

Remaining data gaps not leading to critical areas of concern or issues not finalised but considered necessary to comply with the data requirements, and which are relevant for some or all of the representative uses assessed at EU level. Although not critical, these data gaps may lead to uncertainties in the assessment and are considered relevant.

These data gaps refer only to the representative uses assessed and are listed in the order of the sections:

• Information on the composition of a co‐formulant in ‘FINAVESTAN EMA’ was not available (relevant for all representative uses evaluated; see Section ‘The active substance and the formulation(s) for representative uses’).
• For one of the co‐formulants of the formulation for representative uses ‘FINAVESTAN EMA’, genotoxicity and repeated dose toxicity information over the short and long term was not available; therefore, in order to allow a final conclusion on the safety assessment of ‘FINAVESTAN EMA’, genotoxicity and repeated dose toxicity data for this co‐formulant (short and long term) might be considered for further assessment (to be confirmed by Member States when assessing applications for PPP authorisation; relevant for all representative uses evaluated; see Section ‘General aspects’).
• Further information to conclude on the ecotoxicological safety of the formulation for representative uses (relevant for all representative uses, see Section ‘General aspects’).
• Data of at least five representative batches analysed for impurities, including PAHs, using validated analytical methods according to SANCO/3030/99 rev. 5 and demonstrating compliance of technical paraffin oil (CAS 72623‐86‐0) with the proposed PAHs level of 0.3 mg/kg were missing (relevant for all representative uses evaluated; see Section 1).
• Data of at least five representative batches analysed for PAHs using validated analytical methods according to European Commission (2019) and demonstrating compliance of technical paraffin oil with the proposed PAH level of 0.3 mg/kg were missing (relevant for all representative uses evaluated; see Section 1).
• Specificity data for the analytical method used for the determination of benzene in the technical active substance (data gap, see Section 1).
• Validated analytical methods for monitoring PAHs and benzene in the active substance and the representative formulations were missing (relevant for all representative uses evaluated; see Section 1).
• Data on self‐heating, flash point, surface tension performed under GLP and data on solubility of the active substance in halogenated hydrocarbons were missing (relevant for all representative uses evaluated; see Section 1).
• Data on the explosive and oxidising properties, flash point, auto‐ignition, surface tension, viscosity, density and shelf‐life stability of formulation ‘Finavestan EMA’ were missing (relevant for all representative uses evaluated; see Section 1).
• Appropriate methods for monitoring paraffin oil (CAS 72623‐86‐0) in surface water, air, body fluids and tissues were missing (relevant for all representative uses evaluated; see Section 1).
• Data were not provided to conclude on the sufficiency of the analytical methods used in the following risk assessment studies: B.5.1.2.6/01; KCA 4.1.2/05 KCA 8.2.1/01, Acute toxicity of Paraffin oil CAS 64742‐46‐7 to rainbow trout (Oncorhynchus mykiss) in a 96‐h static limit test; B.5.1.2.6/03; KCA 4.1.2/07; KCA 8.2.4.1/01, Acute toxicity of paraffin oil (CAS 72623‐86‐0) to Daphnia magna in a static 48‐h immobilisation limit‐test.; B.5.1.2.6/07; KCA 8.2.5.3/01, Paraffin oil (CAS 72623‐86‐0): Determination of the effects in a water‐sediment system on emergence of Chironomus riparius using spiked sediment; B.5.1.2.6/19; KCA 4.1.2/15; KCA 8.3.1.2/01, DEV 1502 – A laboratory study to determine the chronic oral toxicity on the adult honey bees Apis mellifera L. (Hymenoptera, Apidae); B.5.1.2.6/20; KCA 4.1.2/16; KCA 8.3.1.3/01, DEV 1502 – A laboratory study to determine the chronic effects on the brood of the Honey Bee Apis mellifera L. (Hymenoptera, Apidae); KCA 4.1.2/18 (submitted as KCP 10.2.3/01), Outdoor microcosm study on the effects of a single dose of Olie‐H (containing paraffin oil) on a water flea (Daphnia sp.) population (relevant for all representative uses evaluated; see Section 1 and 5).
• Scientific evidence demonstrating that the amounts of the components of paraffin oil (CAS 72623‐86‐0) introduced into the soil and in the aquatic compartments from its representative uses will not exceed the natural background levels of these components (relevant for all the representative uses evaluated; see Section 4).
• Satisfactory information on the ready biodegradability of paraffin oil (CAS 72623‐86‐0) (relevant for all the representative uses evaluated; see Section 4).
• Reliable data on the rate of degradation of paraffin oil (CAS 72623‐86‐0) in the aquatic environment, particularly in the sediment compartment are missing for potential exposure refinement and in case such data are necessary for additional evaluation at national level (relevant for all representative uses, see Section 4).
• A comprehensive and transparently reported literature search in line with the EFSA (2011) guidance is not available for the residue and the environmental fate and behaviour sections (relevant for all representative uses, see ‘General aspects’ and Evaluation Table section 4, data requirement 4.13 in EFSA, 2025).
• Further data may be needed to address the off‐field risk to non‐target arthropods other than bees from exposure via overspray (relevant for all representative uses, see Section 5).

ABBREVIATIONS1/n slope of Freundlich isothermAAOELacute acceptable operator exposure levelADEactual dermal exposureADIacceptable daily intakeAFassessment factorAhRaryl hydrocarbon receptorAMAAmphibian Metamorphosis AssayAOELacceptable operator exposure levelAOPadverse outcome pathwayAPalkaline phosphataseARandrogen receptor.ARapplied radioactivityARfDacute reference dosea.s.active substanceASTaspartate aminotransferase (SGOT)AVavoidance factorbwbody weightCASChemical Abstracts ServiceCHOChinese hamster ovary cellsCIconfidence intervalCLconfidence limitsDARdraft assessment reportDATdays after treatmentDT_50_ period required for 50% dissipation (define method of estimation)DT_90_ period required for 90% dissipation (define method of estimation)EECEuropean Economic Community.FAOFood and Agriculture Organization of the United NationsFOCUSForum for the Co‐ordination of Pesticide Fate Models and their UseGAPGood Agricultural Practice.GCgas chromatographyISOInternational Organization for StandardisationJMPRJoint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues (Joint Meeting on Pesticide Residues) K doc organic carbon linear adsorption coefficient K Foc Freundlich organic carbon adsorption coefficientLCliquid chromatographyLC_50_ lethal concentration, medianLOAELlowest observable adverse effect levelLOQlimit of quantificationM/Lmixing and loadingNOAECno observed adverse effect concentrationNOAELno observed adverse effect levelOECDOrganisation for Economic Co‐operation and DevelopmentOMorganic matter contentPapascalPECpredicted environmental concentrationPEC_sed_ predicted environmental concentration in sedimentPEC_sw_ predicted environmental concentration in surface waterpF2pF value of 2 (suction pressure that defines field capacity soil moisture)QSARquantitative structure–activity relationshipRARRenewal Assessment ReportREACHRegistration, Evaluation, Authorisation of Chemicals RegulationSFOsingle first‐orderSMILESsimplified molecular‐input line‐entry systemWHOWorld Health Organization ε decadic molar extinction coefficient λ Wavelength

REQUESTOR

European Commission

QUESTION NUMBERS

EFSA‐Q‐2022‐00735

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Supporting information

APPENDIX B: List of end points for the active substance and the formulation(s) for representative uses