1. REACH: agency decisions and commission risk management

REACH allocates authority according to the regulatory endpoint. ECHA adopts decisions in dossier and substance evaluation, including requests for additional information; the Member State Committee may be central to the agreement reached during the procedure, but the legal act remains ECHA’s. Authorisation and restriction place the final choice with the Commission, acting upon opinions from ECHA’s Committee for Risk Assessment and Committee for Socio-economic Analysis. Article 130 of REACH then extends across this institutional variety by requiring decisions of ECHA, the Commission and competent authorities to state the reasons on which they are based.Footnote ⁷ That allocation reflects the broader development of EU decentralised agencies as centres of expertise and cooperation to which legally consequential powers may be entrusted, while their work remains embedded in relationships with the Commission and national authorities.Footnote ⁸

Article 130 does not prescribe the form or degree of detail of those reasons. During substance evaluation, a designated Member State prepares and revises a draft decision, other competent authorities and ECHA may propose amendments, the Member State Committee seeks unanimous agreement, and ECHA adopts the final act. In Germany v ECHA (T-755/17),Footnote ⁹ which concerned the legal character and review of such an evaluation decision, the General Court placed responsibility at the end of that chain: the Committee’s unanimous agreement formed part of the procedure, whereas the reviewable measure remained ECHA’s decision and was subject to substantive examination by ECHA’s Board of Appeal.Footnote ¹⁰

For the registrant, the Member State draft cannot therefore be the end of the inquiry. ECHA must make clear which concern it has adopted and why the information requested follows from that concern; if the decision is appealed, the Board of Appeal produces a second reviewable act in which it addresses the registrant’s grounds and explains whether ECHA’s decision can stand. The scientific work is layered, but the obligation to state reasons attaches at each stage to the body exercising the relevant legal power.

2. Biocides: ECHA opinions, commission coordination and product authorisation

The BPR provides several routes to the market. An evaluating competent authority examines an active substance, ECHA’s Biocidal Products Committee adopts an opinion, and the Commission decides whether the substance should be approved. A biocidal product may then receive a national authorisation, pass through mutual recognition, or qualify for Union authorisation. The Regulation places express reasons at particular points in this sequence: assessment reports must contain conclusions and grounds, objections during mutual recognition must be explained, and an unresolved disagreement may culminate in a Commission decision.Footnote ¹¹

The mutual-recognition procedure exposes disagreements that might otherwise remain within national files. The reference Member State may conclude that the conditions in Article 19 of the BPR are fulfilled, while another Member State relies upon a local exposure pattern, new incident reports, or a different interpretation of the common assessment. If coordination fails, the matter passes to the Commission, sometimes after an ECHA opinion, and the Commission must determine whether the common authorisation should stand, whether territorial conditions are needed, or whether continued authorisation can be supported only by an exception.

The consequences can be illustrated by the alphachloralose rodenticide dispute in SBM Développement. Footnote ¹² The product had been authorised for indoor mouse control, but reports of poisoning in dogs and cats led France and Sweden to amend their authorisations; Denmark and Germany objected, and coordination failed. The Commission accepted that the ordinary animal-health condition in Article 19(1)(b)(iii) of the BPR was not fully satisfied, yet permitted authorisation under Article 19(5) where withdrawal would have disproportionate societal effects, subject to local mitigation. The decision combined incident reports, uncertainty over attribution, divergent national experience and an exceptional balancing clause. Because the Commission exercised its own power in resolving the dispute, its reasons had to explain how that material supported both the exception and the conditions.

In Elector,Footnote ¹³ Member States disagreed over soil predicted no-effect concentration (PNEC) values for spinosad and its metabolites. Values used at active-substance approval indicated unacceptable soil risk; refined product-level values led to the opposite conclusion. ECHA’s Biocidal Products Committee accepted the refinement, and the Commission directed the renewal procedure to use it. Authorisation therefore depended on a methodological choice within the assessment, so the reasons had to identify the accepted value and explain why it was reliable enough to control the legal outcome.

3. Plant protection products: a formal assessment–management division

The PPPR states the allocation of functions more expressly. A rapporteur Member State prepares the draft assessment of an active substance, EFSA conducts an independent scientific peer review, and the Commission adopts the approval or renewal measure. Recital 12 to the PPPR describes these functions as risk assessment and risk management.Footnote ¹⁴ The glyphosate literature has nevertheless shown that the formal distinction does not prevent evaluative choices from entering the assessment stage or disagreements among assessors from shaping the regulatory outcome.Footnote ¹⁵ The commercial route continues after Union approval, because one Member State assesses the product application within a regulatory zone and the other concerned Member States decide whether the product may be authorised on their territories.Footnote ¹⁶

At active-substance level, the Commission reads EFSA’s conclusion together with the rapporteur Member State’s report, decides whether the approval criteria are satisfied, and determines whether restrictions can bring a representative use within the statutory threshold. Product authorisation introduces a further transfer of responsibility. Although concerned Member States ordinarily rely upon the zonal assessment, each remains responsible for the product placed on its market. Article 36(3) of the PPPR governs the point at which that reliance breaks down by requiring a refusing Member State to provide the applicant and the Commission with a technical or scientific justification connected with its environmental or agricultural circumstances.Footnote ¹⁷

Recent judgments confirm that no single document settles every later decision. EFSA’s conclusion carries considerable authority, but a national authority must still engage with reliable scientific material that arose outside or after the common assessment.Footnote ¹⁸ The Commission, for its part, must explain why conditions or mitigation answer a critical concern identified during peer review.Footnote ¹⁹ The PPPR therefore brings the practical stakes into particularly sharp relief, since a producer may receive a favourable Union renewal and still confront a national refusal, with each authority relying upon a different part of the scientific record.

1. Evidence, data gaps and the need for further information

A scientific assessment selects evidence, characterises uncertainty and determines whether a data gap prevents a legal conclusion.Footnote ²⁰ Those choices shape the subsequent decision before the risk manager has selected a response. The assessment should consequently identify the studies and assumptions upon which the analysis turns, the uncertainty that remains, and the reason why further information is required or may safely be dispensed with.

In BASF Grenzach,Footnote ²¹ ECHA required the sole triclosan registrant to conduct an enhanced developmental-neurotoxicity study in rats, a fish sexual-development test and a simulation test of ultimate degradation in fresh and marine water. BASF argued that existing studies had already answered, or weakened, the concerns said to justify those costly tests. The General Court held in the consequent Case T-125/17Footnote ²² that ECHA had to consider relevant information but retained judgment over what it established. For the rat study, ECHA was “not required to demonstrate” that triclosan was already neurotoxic, because the test sought to resolve a concern left open by the existing material.

A comparison of ECHA’s 2014 triclosan decision with the Board of Appeal’s 2016 rulingFootnote ²³ makes the point more precisely. The initial decision separates the rat, fish and persistence tests and states the information to be supplied; the appellate decision then addresses BASF’s objections test by test. The package can be followed, although the uncertainty controlling each request often becomes clearer through the appellate exchange than it was in the original information request. Where a registrant faces costly testing, ECHA, as the decision-maker, should identify in the decision itself the unresolved proposition with sufficient precision for the registrant to understand why the additional information is required. The registrant and the Board of Appeal should not have to reconstruct the basis of the request for the first time from explanations supplied during the appeal and the underlying scientific record.

Public access to data, models and methods enables outsiders to examine the assessment and is indispensable to the credibility of agency science.Footnote ²⁴ Even a well-organised repository, however, will not necessarily disclose which uncertainty controlled the particular ECHA decision. The statement of reasons performs that selective task by identifying the material that carried weight and explaining why it left a regulatory question unresolved.

2. Current knowledge and the temporality of assessment

Risk decisions are particularly exposed to temporal mismatch. Applications may remain under assessment for several years, guidance develops during the procedure, and new studies may appear before the final authorisation. Because the PPPR repeatedly refers to current scientific and technical knowledge, the Court has resisted interpretations that would freeze the assessment at the date of application or at the guidance available when the dossier was first submitted.

In the joined Dutch preliminary-reference cases C-309/22 and C-310/22 (PAN Europe)Footnote ²⁵ concerning endocrine-disrupting properties, the Court held that a national authority deciding upon a plant-protection product had to consider relevant and reliable scientific knowledge available at the time of its own examination. The zonal procedure did not entitle the authority to disregard later material merely because the reference assessment had been completed under an earlier scientific framework; the authority remained answerable for the lawfulness of the decision on the record then before it.

The zonal-authorisation judgment in C-308/22 [PAN Europe (Closer)]Footnote ²⁶ applied the same reasoning to reliance upon another Member State’s assessment. The conclusions of the assessing Member State were the normal basis of the system, but they were not irrebuttable: a concerned Member State could depart where reliable scientific or technical data not previously considered indicated an unacceptable risk. A national court, in turn, could examine whether the assessment supported the authorisation, provided that it did not substitute its own scientific appraisal for that of the competent authority.

Mutual reliance remains indispensable to the operation of the zonal system, but its authority depends upon a reasoned response when reliable new material challenges the common assessment. The concerned Member State must explain either why the information leaves the shared conclusion intact or why it changes the decision for its territory. In this context, “current scientific and technical knowledge” becomes part of the authority’s account of the decision rather than a formula confined to the substantive provision.

3. The relationship between scientific assessment and final decision

A comprehensive scientific assessment still does not determine the final regulatory choice. EFSA, ECHA or a rapporteur Member State may characterise the hazard and quantify the uncertainty, while another authority decides whether the statutory conditions permit approval, require further information or justify intervention.Footnote ²⁷ The administrative record should mark that transfer of responsibility, since an expert opinion may otherwise appear to resolve a regulatory choice it was not empowered to make, or the risk manager may conceal disagreement with the scientific analysis behind a general reference to discretion.

Assessment and management cannot be separated by a rigid institutional wall. The selection of endpoints, models and uncertainty factors already involves evaluative judgment, while the design of regulatory conditions may require further technical analysis. The public-law inquiry is therefore more exact: when responsibility passes from one body to another, does the record disclose the proposition accepted by each body and the inference for which it assumes responsibility?

1. From scientific concern to unacceptable risk

The general EU duty to state reasons is deliberately flexible. Article 296 of the Treaty on Functioning of the European Union (TFEU) and Article 41(2)(c) of the Charter of the EU require Union bodies to disclose their reasoning sufficiently to enable those concerned to understand the act and the Courts to review its legality; the adequacy of the statement is assessed in the light of the measure’s wording, its context and the body of legal rules governing it. The authority is not required to address every fact or argument, but the reasons must disclose the essential path by which it reached the result.Footnote ²⁸

The Commission restriction of D4 and D5 examined in C-558/21 P (Global Silicones Council)Footnote ²⁹ shows how that contextual standard operates. The amending Regulation 2018/35Footnote ³⁰ announced the prohibition and its recitals identified the Annex XV dossier, the findings concerning the substances’ persistence, bioaccumulation and toxicity, and the opinions of the Committees for Risk Assessment and Socio-economic Analysis, stated that wash-off uses created an environmental risk, and explained why a concentration limit of 0.1% would eliminate intentional use. The act thus presented a recognisable sequence from evidence to regulatory response, although it did not reproduce the exact expression “unacceptable risk” used in Article 68(1) REACH.

The applicants in Global Silicones Council treated the omission of that expression as a defect in the statement of reasons. The Court rejected the plea and reiterated that “the question whether the statement of reasons is sufficient must be assessed with regard not only to its wording but also to its context.”Footnote ³¹ Read together with the public dossier and committee opinions, the regulation necessarily conveyed the Commission’s conclusion that the environmental risk was unacceptable.

That conclusion is persuasive when the issue is whether the measure could be understood and reviewed, particularly because the regulation contained more than a bare incorporation by reference. It leaves a narrower question about the Commission’s own regulatory judgment. ECHA’s committees assessed persistence, bioaccumulation, exposure and socioeconomic consequences, whereas the Commission selected the scope, threshold and conditions of the restriction. The sequence allowed that choice to be reconstructed, but the precise point at which the scientific concern became an unacceptable risk remained largely implicit in the legal context and the outcome. A more complete statement of reasons would identify that decisive inference as the Commission’s own.

2. Conditions and mitigation as part of the justification

A decision that merely lists protective measures leaves unresolved whether they can be implemented under realistic conditions and whether they reduce the identified risk sufficiently to satisfy the statutory threshold. The reasons should connect each material condition with the concern it is intended to address.

This difficulty can be illustrated by the renewal of cypermethrin. The Commission relied on restrictions, mitigation measures and confirmatory information to permit continued approval despite several critical concerns identified during the scientific peer review.Footnote ³² The relevant administrative record comprises EFSA’s conclusion, the Commission’s 2021 renewal regulation and the subsequent decision rejecting PAN Europe’s request for internal review. EFSA identified four critical areas of concern, including uncertainty over whether the ecotoxicological test batches were representative of the technical material to be marketed and a high risk to non-target arthropods.Footnote ³³ After EFSA considered possible mitigation, the Commission renewed the approval, classified cypermethrin as a candidate for substitution and imposed restrictions and confirmatory-information requirements. PAN Europe’s internal-review request therefore required the Commission to explain how those conditions answered the concerns identified during peer review.

In C-316/24 P (PAN Europe v Commission),Footnote ³⁴ the Court of Justice preserved the Commission’s discretion but required a traceable account. On representativity, the General Court had “not state[d] the reasons why it was necessary to give priority to the position of the RMS over that of EFSA.”Footnote ³⁵ The claim that EFSA had confirmed the irrelevance of certain impurities needed support in an identifiable study or EFSA document. For non-target arthropods, the Commission itself had to verify that the proposed safe use operated under realistic conditions rather than defer the issue entirely to national authorisation.

The General Court’s earlier judgment had been criticised for applying the precautionary principle too formally when it accepted the Commission’s reliance upon its discretion as risk manager despite EFSA’s critical concerns. The appeal judgment’s insistence upon identifiable scientific material and realistic mitigation addresses the same difficulty in more exacting terms.Footnote ³⁶

The possible regulatory routes matter differently to the approval holder and to an environmental challenger. The Commission may reject EFSA’s scientific premise, accept the concern but demonstrate that realistic mitigation brings the use within the statutory threshold, or conclude that a defined information gap may lawfully be filled at a later stage. Its reasons should state which course it has adopted. The cypermethrin record contained the principal documents, yet their disagreement was left to be reconciled to a considerable extent during judicial review.

3. Balancing, substitution and exceptions

Certain decisions under chemicals legislation require an express balance between risk and competing considerations. REACH authorisation may rest upon adequate control or, where that route is unavailable, upon socioeconomic benefits outweighing the risk in the absence of suitable alternatives.Footnote ³⁷ The BPR permits approval of some active substances meeting exclusion criteria only under defined exceptions, including negligible risk, essentiality or disproportionate negative effects for society if approval is refused.Footnote ³⁸ The scientific assessment describes hazard and exposure, but the legal exception requires the competent authority to make and explain a further judgment.

The Commission’s renewal of creosoteFootnote ³⁹ under the BPR illustrates that further judgment. Creosote presented carcinogenic and environmental concerns, while the decision also considered the socioeconomic consequences of withdrawal and the availability of alternatives for uses such as railway sleepers and utility poles before imposing conditions upon continued approval. The proceedings in T-9/23 (Koppers Denmark)Footnote ⁴⁰ did not yield a full merits judgment on that balance because the action failed on admissibility and severability. The administrative measure nevertheless demonstrates the need to distinguish, within the reasons, the risk established by the evidence from the legal and socioeconomic grounds upon which the exception and its conditions depend.

Substitution requires a similarly comparative account. Hazard classification or candidate status initiates the inquiry, but it does not identify the viable alternative, the period reasonably needed for transition, or the distribution of the resulting costs. Since those choices determine who bears the practical consequences of precaution, they belong in the authority’s reasons rather than remaining implicit in the designation of the substance.

1. Adoption by reference

Multi-stage administration makes incorporation by reference unavoidable.Footnote ⁴¹ A Commission regulation need not reproduce an ECHA or EFSA opinion, just as an ECHA decision need not repeat every passage of a Member State evaluation. The legal question is whether the external material has been identified and adopted with sufficient clarity to form part of the reasons of the final authority. Such procedures form part of a wider post-Lisbon executive architecture in which delegated and implementing acts coexist with executive powers conferred directly upon specialised agencies.Footnote ⁴²

Contextual reasoning is accepted where the administrative sequence is defined and accessible. In C-558/21 P (Global Silicones Council),Footnote ⁴³ the Court relied on the Annex XV dossier, committee opinions and recitals because the Commission had adopted that sequence and its conclusions. Case T-755/17 (Germany v ECHA)Footnote ⁴⁴ likewise preserved ECHA’s authorship despite Member State Committee participation. Public access to expert material does not itself show that the final authority accepted its findings or assumed responsibility for the regulatory inference.Footnote ⁴⁵ Incorporation by reference works when the act identifies the accepted assessment and conclusion; the existence of a large file cannot do so.

The point is particularly important where the documents serve different legal functions. A rapporteur report may describe the dossier, an agency conclusion may resolve scientific questions, a committee opinion may compare possible regulatory responses, and the Commission may decide upon acceptability, conditions and proportionality. If the entire file is treated as an undifferentiated statement of reasons, the allocation of expertise and authority that the procedure was designed to create becomes obscured.

2. Departure and unresolved disagreement

A risk manager may depart from expert advice within the discretion conferred by the legislation, but the reasons required become more focused as the disagreement becomes more consequential. They should identify the scientific proposition in dispute, state how the competent authority has treated it and explain the effect of that treatment upon the regulatory outcome.

The cypermethrin judgment in C-316/24 P (PAN Europe v Commission)Footnote ⁴⁶ demonstrates that requirement where EFSA and the rapporteur Member State took different positions. The BPR mutual-recognition procedure presents a horizontal counterpart. If the Member States cannot resolve an objection, the Commission’s decision should explain how the objection bears upon the Article 19 conditions, which scientific assessment it accepts, and why any territorial variation is sufficient or unnecessary. The alphachloralose judgment in T-667/22 (SBM Développement)Footnote ⁴⁷ confirms that the Commission exercises its own power at that stage; accordingly, the reasons must be attributable to the Commission even where they draw heavily upon national and ECHA materials.

3. What must remain visible across the administrative record

The preceding examples reveal recurring points at which the reasoning of a composite procedure becomes difficult to follow.

First of all, the scientific matter that controlled the decision must be identifiable. In the triclosan proceedings, the issue was whether existing studies had resolved particular concerns sufficiently to make further testing unnecessary. In Global Silicones Council, the relevant findings could be traced through the Annex XV dossier, committee opinions and recitals. An applicant need not receive the full scientific record, but should be able to determine which finding, uncertainty or data gap carried decisive weight.Footnote ⁴⁸

Furthermore, the record should show how scientific assessment became a legal result. The D4/D5 restriction could be understood as resting on unacceptable environmental risk, although that conclusion remained largely implicit. The cypermethrin case presented the converse problem as EFSA identified critical concerns, while the Commission relied on restrictions, mitigation and confirmatory information to renew approval. In each setting, the question is how the selected scientific propositions support the threshold and measure.Footnote ⁴⁹

Last, responsibility must remain visible. Germany v ECHA judgement confirms that national and committee participation does not displace ECHA’s authorship of the final substance-evaluation decision; judgment in SBM Développement likewise treats the Commission’s resolution of a BPR disagreement as an exercise of its own power. A clear reference may suffice where the final authority adopts expert advice. Where it chooses between competing assessments, modifies their implications or relies on mitigation, its own judgment should be apparent.Footnote ⁵⁰

Identification, transition and attribution are therefore shorthand for analytical questions drawn from the cases. They help apply the contextual standard of Article 296 TFEU to procedures in which evidence and authority are distributed among several bodies. A court need not repeat the scientific assessment, but it must be able to identify the evidential basis, follow the inference and locate responsibility.

1. The PPPR zonal system

National product authorisation adds a second level to EU chemicals governance. Under the PPPR, active substances are approved at Union level, whereas products are authorised by the Member States. Within each regulatory zone, one Member State assesses the application and the others ordinarily rely upon that assessment, although each concerned Member State remains legally responsible for the product placed on its own market.

In the abovementioned zonal-authorisation judgment in PAN Europe (Closer), the Court treated the reference assessment as the normal basis for mutual reliance rather than as an irrebuttable command. Reliable data not previously considered could disclose an unacceptable risk and justify refusal by a concerned Member State, in which event Article 36(3) of the PPPR required a technical or scientific justification.Footnote ⁵¹ Recent commentary accordingly describes the judgment as a “trust but verify” model of mutual reliance, in which the reference assessment remains the normal starting point but must yield when current and reliable scientific material calls its conclusions into question.Footnote ⁵² For the applicant, the reasons must reveal whether the refusal rests upon new evidence, a defect in the shared assessment, or environmental and agricultural circumstances specific to the Member State, since each ground calls for a different form of challenge.

The Court also accepted that a concerned Member State need not invariably return an inadequately reasoned assessment to the zonal evaluator before acting. That procedural flexibility places additional weight upon the national decision. The producer must be able to determine whether the dispute concerns the reliability of a new study, the alleged territorial specificity of the risk, or the legal conclusion that the risk is unacceptable; a generic reference to national circumstances would conceal those distinct grounds.

2. BPR mutual recognition

The BPR addresses the same problem through a more visible dispute procedure. The objecting Member State must formulate its concern, the coordination group records the positions taken, and an unresolved disagreement moves to the Commission.Footnote ⁵³ The alphachloralose proceedings in SBM Développement involved incident evidence, animal-health risk, mitigation and the exceptional balance under Article 19(5) of the BPR.Footnote ⁵⁴ The spinosad dispute in Elector concerned a narrower scientific issue capable of reversing the outcome: whether refined or unrefined soil PNEC values should be used for spinosad and its metabolites. The unrefined values indicated an unacceptable soil risk, whereas the refined values accepted by ECHA’s Biocidal Products Committee did not. The Commission’s decision therefore needed to identify the controlling parameter and explain why the refinement could properly determine the authorisation.Footnote ⁵⁵

The resulting explanation may be distributed among the initial authorisation, national objections, coordination documents, an ECHA opinion and the Commission decision, but those documents do not perform the same task. The objecting authority identifies the scientific or territorial concern, ECHA may resolve the technical issue, and the Commission assumes responsibility for the final judgment on the authorisation conditions. Repetition is unnecessary; what is required is a sufficiently clear indication of the conclusions accepted by the Commission and of their bearing upon the result.

3. A common EU floor and national procedural variation

Union legislation harmonises more than the substantive conditions of product authorisation. Article 36(3) PPPR and the objection provisions of the BPR identify circumstances in which national divergence must be justified in common scientific or technical terms. National administrative law may nevertheless govern the form of the decision, the ordinary degree of detail required and the consequences of a defect. EU law thus establishes a common floor where a national measure affects mutual recognition, access to the market or a harmonised environmental threshold.

Recent Dutch and French judgments adopted between 2023 and 2026 illustrate this two-layered system. The Dutch cases continue the PPPR preliminary-reference proceedings discussed above; the French cases concern national authorisation and mutual recognition. They illustrate how harmonised scientific questions enter national requirements of preparation, reasons and remedies, without purporting to survey Member State practice.

After the CJEU held that a national authority deciding on a plant-protection product must consider relevant and reliable scientific knowledge available at the time of its assessment, the Dutch Dagonis proceedings returned to the College van Beroep voor het bedrijfsleven, the specialist Trade and Industry Appeals Tribunal. The Tribunal held that the Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) had not adequately explained why PAN Europe’s material did not support identifying difenoconazole as an endocrine disruptor, and required a fresh decision.Footnote ⁵⁶ In Belem, Ctgb addressed the relevant studies only after deciding the administrative objection, so the explanation came too late to support the challenged decision.Footnote ⁵⁷ In Wasan, the Tribunal rejected postponement of current evidence until a later active-substance review and found that Ctgb had not adequately explained why it omitted a comparative assessment against a potentially less harmful product.Footnote ⁵⁸ The combination of the requirements translates into the practical scenario in which EU law identified the scientific questions and Dutch administrative law required timely, reviewable answers in the decision itself.

The French judgments similarly examine whether the national authority addressed the scientific matter made decisive by harmonised EU law. The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) authorises plant-protection products. In 2026 Kyléo, the Versailles Administrative Court of Appeal annulled ANSES’s renewal of an authorisation for an herbicide containing glyphosate and 2,4-D because the assessment had not given the “particular attention” required by the EU glyphosate approval to indirect biodiversity effects through trophic interactions. The absence of a harmonised method did not permit ANSES to leave that concern unexamined.Footnote ⁵⁹ In Mastana SC, the Melun Administrative Court upheld ANSES’s refusal to recognise an authorisation granted in another Member State because the underlying dossier contained residue studies for central and northern Europe but did not cover conditions relevant to southern France. The obstacle was a gap in the territorial coverage of the shared assessment, not a free-standing French disagreement with its conclusions.Footnote ⁶⁰

The Dutch judgments demand contemporaneous engagement with evidence and comparative assessment; the French judgments ask whether the file covers the environmental concern or territory specified by EU law. The examples show that a common EU scientific floor neither dictates a single form of reasons nor a uniform remedy, but the addressee must still be able to identify and challenge the obstacle.

1. ECHA’s board of appeal

Administrative review may sharpen the statement of reasons by converting a broad scientific dispute into pleaded grounds. ECHA’s Board of Appeal reviews appealable ECHA decisions with specialised legal and scientific capacity. It is neither a court nor a continuation of the original evaluator.Footnote ⁶¹ The substance-evaluation judgments in Germany v ECHA and BASF Grenzach have been described by Chamon and Volpato as establishing a middle course: the Board may examine substantive error and is not confined to external legality, yet its task remains directed to the appellant’s pleas rather than to repeating the assessment from the beginning.Footnote ⁶²

The Board should therefore explain whether ECHA identified the scientific concern, whether the material supported exercise of the relevant power, and whether the study or condition imposed answered that concern. A general invocation of ECHA’s discretion would fail to resolve the appeal, whereas a complete repetition of the substance evaluation would improperly convert the Board into the first-instance assessor.

2. Aarhus internal review and later reasons

Aarhus internal review produces a different second act. An environmental organisation may ask a Union institution to reconsider an administrative act under environmental law. In such case, the institution responds in writing, and any subsequent proceedings are directed against the rejection of that request.Footnote ⁶³

Judgments in C-82/17 P (TestBioTech)Footnote ⁶⁴ and C-458/19 P (ClientEarth)Footnote ⁶⁵ require the applicant to formulate grounds capable of casting serious doubt upon the legality of the underlying act. The reply may consequently become the most focused statement of why the institution continues to regard the original measure as lawful.

Chemicals and pesticide litigation increasingly employs this mechanism. The cypermethrin proceedings began with a Commission decision rejecting PAN Europe’s request for internal review, and that reply organised the Commission’s answers to EFSA’s critical concerns in a form that could be challenged directly. The distinction between the two acts is important. Implementing Regulation 2021/2049 stated that it was appropriate to renew the approval of cypermethrin as a candidate for substitution and laid down restrictions, risk-mitigation measures and requirements for confirmatory information.Footnote ⁶⁶ The Commission’s 2022 internal-review decision subsequently gave a fuller explanation of why it considered those measures sufficient in response to PAN Europe’s objections. That later explanation forms part of the reasons for rejecting the request for internal review; it cannot retrospectively be treated as part of the statement of reasons given for Implementing Regulation 2021/2049 when that regulation was adopted.

The internal-review reply addresses a later and distinct question: whether, in the light of the objections raised in the request for review, the institution continues to regard the original measure as lawful. It should identify both the scientific challenge and the institution’s legal and regulatory answer to it.