Substance evaluation under REACH and 9 December 2020 ......Substance evaluation under REACH and appeals before ECHA's Board of Appeal 15 T-636/17: PlasticsEurope v. ECHA, confirming



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Dossier compliance Substance evaluation

Legal source Title VI Chapter 1 of REACH Title VI Chapter 2 of REACH

Objective Compliance check / testing proposals (art. 40-41) Verification that the information submitted by registrants is compliant with legal requirements(Annexes VII, VIII, IX, X)

Assess dossier / request for further information to clarify a risk to human health or the environment (art. 44-48)

Possible outcomes

- No action (dossier compliant/complete)- Decision to request additional (standard)

information

- Risks judged to be sufficiently controlled with measures already in place

- RMOA - Identification of SVHC (then Annex XIV)- Harmonised classification- Restrictions

Dossier compliance vs Substance evaluation



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Evaluation: Overview



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• SEV assesses all dossiers from all registrants of the same substance

the cost stemming from a request for new information would need to be shared among all registrants

• Right to comment acceptable in relation to the draft decision

Informal discussions may be organized with ECHA desk officers

• Right to comment in relation to Proposals for Amendments (if any)

– But no right to comment on revised draft decision

• Right to comment during 12 months assessment by MS and then on the evaluation dossier / Conclusions

Depends on discretion and practice of individual Member States (France, Germany etc.)

Legal background – Substance evaluation (SEV)



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Carbon tetrachloride case (Akzo Nobel 1) – Decision A-005-2014 of 23 Sept 2015

• ECHA reviewed dossiers from the six registrants and requested additional EOGRTS.

• Reason: dossier of registrant with highest tonnage band was missing EOGRTS, which isstandard information for that tonnage band.

• Appellants argued EOGRTS was disproportionate and unnecessary, existing data showsthat repro toxicity only occurs at very high levels of exposure and sufficient measures are inplace to ensure human health protection no improved risk management

• On 23 Sept 2015, BoA annulled the ECHA decision.

Legal criteria to challenge substance evaluation decisions requesting new studies: Recent Board of Appeal cases



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Main findings of the Board of Appeal:

• BoA set out a three-tier test that ECHA must satisfy before it can request additional information under substanceevaluation:

o Potential environmental or health risk – a risk that “occurs in reality and not only theoretically”;

o Proof that the potential risk needs to be clarified; and

o Information requested has realistic possibility of leading to improved risk management measures.

BoA concluded that ECHA had not met these criteria because:

• Carbon tetrachloride already subject to extensive RMM and ECHA could not show that these were inadequate.

• ECHA's assertion that there was a concern on reproductive toxicity was insufficient since it did not identify a precise riskand did not demonstrate that the study would lead to any improvement to risk management.




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SI Group-UK and Oxiris Chemicals – Decision A-008-2017 of 25 September 2018

BoA annulled ECHA SEV decision of 23 March 2017 on TBMD requesting two studies (incl. EOGRTS) with non-standard parameters.

Main arguments of the appeal:

• Failure to fulfil conditions for further information requirements under Art 46 REACH and provide adequate reasons, e.g. onpotential risk.

• Failure to explain how new information would lead to an improvement of RMM.

• Requirement to conduct an EOGRTS based on error of assessment and insufficient weight-of-evidence.

Main findings of the Board of Appeal

• ECHA failed to assess whether available information showed 'serious concerns about the potential for adverse effects on fertilityor development' within the meaning of Annex VIII, Column 2, Section 8.7.1. REACH, and thus whether EOGRTS was required forsome or all registrants.

• Hence rights of some registrants may have been prejudiced by requesting the study under SEV rather than dossier compliance.

Legal criteria to challenge SEV decisions requesting new studies: Recent Board of Appeal cases



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Evonik Degussa GmbH and Others – Decision A-015-2015 of 30 June 2017

ECHA requested info on each individual silicon dioxide form. BoA maintained request 90-day sub-chronic tox but annulled all other requests.

Main Arguments of the Appeal

• REACH does not require information on “forms” of substances.

• Failure to establish a potential risk justifying requests for information -- the fact that substance is a nanomaterial is not sufficient.


• Being a nanomaterial is insufficient on its own to justify potential risk. Under SEV procedure, ECHA must demonstrate a concern justifyingthe request for further information (on nanomaterials).

• No causal link between size and hazardous properties. Identification of potential risk is based on hazard + exposure (Akzo Nobel 2).

• In assessing potential risk, where there is high exposure to a substance, evidence of potential hazard may be correspondingly less.

• A contrario, the lower exposure to a substance, the higher the potential hazard needs to be demonstrated …?




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Symrise AG – Decision A-009-2016 of 8 August 2018

BoA annulled ECHA’s decision of 30 June 2016 on SEV of climbazone requesting submission of EOGRTS.

Main arguments of the Appeal

• Substance used exclusively as ingredient in cosmetic products, there is a ban on animal testing under EUCosmetics Regulation (EC) No 1223/2009.

• Infringement of procedural rights, including a violation of the right to comment the draft decisionimposing further testing requirements.


• The appellant's right to be heard has been violated as regards EOGRTS : appellant had the opportunityto comment on the initial proposal for OECD 422 study (reproductive toxicity), but not on Danishproposal for EOGRTS (new request).

Legal criteria to challenge SEV decisions requesting new studies: Recent Board of Appeal cases



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3v Sigma S.p.A. – Decision A-004-2017 of 15 January 2019

The BoA upheld ECHA’s decision of 20 Dec 2016 on UVASORB HEB, requiring an OECD TG 308 study.

BUT -- BoA annulled the decision requesting further information on uses and environmental emissions.


• OECD TG 308 study: ECHA correctly concluded that QSAR models used for screening for bioaccumulation were unreliablefor calculation of bioconcentration, and OCDE TG 308 study was more appropriate for clarifying potential risk.

• Further information requirement: while ECHA justified the request based on absence of exposure assessment in theregistration dossier, in this case, it was not yet known whether any transformation products were in fact PBT or vPvB.

• Therefore, ECHA failed to demonstrate the necessity or appropriateness of the request, or to identify the informationrequested.




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BASF SE Germany (Decision A-003-2018) and Kemira Oyj Finland (Decisions A-004-2018 and A-005-2018) of 17 December 2019

BoA annulled ECHA’s decisions of 21 December 2017, requesting OECD TG 474 and OECD TG 489 studies in rats, using aluminium sulphate.


• Lack of clarity regarding which of the substance(s) present a genotoxicity concern.

• ECHA failed to demonstrate potential risk, or to adequately examine how new information could lead to improved RMMs.

• ECHA committed error of assessment in concluding that, if the read-across from aluminium hydroxide was accepted,results of the 2010 study on aluminium hydroxide were not relevant to the assessment of the genotoxicity of the threeSubstances.

• Therefore, ECHA failed to demonstrate that the contested information requirement was necessary.




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Taminco BVBA and Performance Additives Italy S.p.A. – Decision A-008-2018 of 29 January 2020

BoA annulled ECHA’s decision of 13 February 2018 on the SEV of Ziram, requesting submission of a combined developmentalneurotoxicity study (OECD TG 426) and neurotoxicity study in rats (OECD TG 424), oral route via feed, including additional investigations in the OECD TG 424 part of the study.


• No evidence of a link between parkinson and exposure to Ziram. Hence, ECHA failed to demonstrate a potential risk.Decision annulled insofar as it related to the neurotoxicity study.

• ECHA’s decision did not provide sufficient information for the BoA to decide whether the requested developmentalneurotoxicity study, when performed without the neurotoxicity study, would provide additional information.

• The BoA annulled ECHA's decision in its entirety and remitted it to ECHA for further action regarding the developmentalneurotoxicity study.




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A-007-2019: Chemours Netherlands B.V., the Netherlands (received 17 May 2019), contesting ECHA’s request to conduct a carcinogenicity study in mice in accordance with OECD test guideline (‘TG’) 451.

Main arguments of the Appellant

• Manifest error of assessment in concluding that there is a mutagenicity concern for the Substance;

• Breach of Article 25 of REACH in requiring a study using a large number of animals when results from this study will not lead to improved RMM, and failure to adequately consider less strict alternatives;

• Breach of principle of proportionality in failing to demonstrate that the requested study would be necessary or appropriate, as the study results will not lead to improved RMM.

Pending Board of Appeal cases



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T-636/17: PlasticsEurope v. ECHA, confirming decision of BoA of ECHA and classification of Bisphenol A as ED.

• EU Court rejected Appellant’s argument that it was disproportionate to include BPA on the candidate list as an ED due to it being used mainly an intermediate (exempt from authorization).

• Despite REACH referring to an ‘intermediate’ as though it were a certain type of substance, it is not referring to a substance of a ‘special nature’ but to a “certain type of use” of a substance.

• The Court also rejected Appellant’s argument that ECHA failed to establish probable serious effects to human health.

T-125/17: BASF Grenzach GmbH v ECHA, confirming ECHA's request for BASF to provide further information on Triclosan, including information obtained via testing on animals.

• With respect to all three tests requested by ECHA and contested by the Applicant, Court dismissed the Appellant’s arguments that ECHA breached the principle of proportionality and failed to take animal welfare into account.

General Court judgments of 20 September 2019



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T-755/17: Germany v. ECHA, partially annulled decision of BoA insofar as the claim that the substance Benpat is bioaccumulative be deleted from the grounds for ECHA's requirement that further testing need to be conducted.

• Court considered that errors identified by BoA in contested ECHA decision were not critical of calling into question the operative part of ECHA’s decision in relation to the claim that benpat is bioaccumulative.

• Appellant’s arguments on breach of proportionality were dismissed – the Court recalled the AkzoNobel 1 three-tier test and considered that the BoA had respected these criteria.

General Court judgments of 20 September 2019



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After the SEV process, a substance may be identified as a SVHC by Commission Implementing Decision, and on that basis, included on the REACH Annex XIV Candidate List by ECHA Decision.

BUT only the Commission decision may be challenged before EU Court:

• Sasol Germany, SI Group Béthune and BASF v. European Commission (pending)

• Sasol Germany, SI Group Béthune and BASF v. ECHA (action dismissed: inadmissible)

Legal criteria to challenge SVHC listing as a result of substance evaluation:cases before the General Court



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• Andrew Fasey and Luca Bolzonello (Chemical Watch, 13 August 2020):

“On the one hand, Article 46 places considerable power in Echa’s hands … Echa has thepower to require from registrants a broad range and depth of information, provided that:o the information is necessary to clarify a potential risk;o that it might lead to improved RMM; ando that it is demonstrably possible for registrants to provide that information.”

“On the other hand, Echa must exercise its power with all due care. It must have particularregard to ensuring that requests for further information are adopted in a way that isprocedurally correct and that the requests are adequately justified, and that they candemonstrably achieve their aim.”

BoA in substance evaluation: balancing “competing considerations”



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• ECHA must apply Akzo Nobel legal test for imposing further information requirementsunder Art 46 REACH. This has been confirmed by the BoA and EGC.

• ECHA must apply proper "weight of evidence" to justify request for additional information.

• ECHA must comply with EU law principles of proportionality / animal welfare.

• BoA will review facts, law and science to determine any irregularities.

• Cases not reviewed by BoA may be brought before European Court.

Conclusion



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Substance evaluation under REACH and 9 December 2020 ......Substance evaluation under REACH and appeals before ECHA's Board of Appeal 15 T-636/17: PlasticsEurope v. ECHA, confirming