Registrants’ dossiers under the European Union’s REACH program may be subject to intensified scrutiny for animal testing performed in violation of the law’s “last resort” principle, in light of a recent decision from the European Ombudsman and pressure from the animal-welfare community.

The European Chemicals Agency may be quicker to request clarification from registrants on why they conducted animal tests and their basis for believing that no alternative methods were available to provide the same data, and referrals to member states for possible enforcement could be more routine for suspected noncompliance.

The PETA International Science Consortium, established in 2012 to coordinate the scientific and regulatory expertise of PETA and its affiliates, is urging European Parliament members to lean on the European Commission to ensure that “compliance with the spirit and content of REACH is assured from this point forward” when it comes to animal testing conducted to meet chemical data requirements.

Specifically, PISC seeks steps from the EC to promote ECHA’s adherence to recommendations laid out in a December 2014 “friendly solution proposal” from the European Ombudsman, which held generally that due to a narrow interpretation of its capabilities and responsibilities under REACH, ECHA has not been exercising its duties to the full extent possible and as directed by the legislation when evaluating registrant dossiers to identify unnecessary animal testing.

The EU’s Registration, Evaluation, Authorization and Restriction of Chemicals law specifies that “for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods,” and that animal testing “shall be undertaken only as a last resort.”

On its website, PISC says PETA UK learned in 2011 “that tens of thousands of animals were being poisoned and killed in potentially avoidable tests, contrary to the REACH regulation.” The group cites ECHA’s tri-annual report from 2011 on use of alternative tests under REACH as evidence.

Among other contraventions of the last-resort principle, PETA claims that up to 1,000 animals underwent painful skin and eye irritation tests even though validated non-animal tests exist.

Further, the group says registrants conducted animal tests without first proposing them for public review and agency approval, while others carried out animal tests “despite advice from ECHA that certain screening tests could be omitted if proposals were made for more extensive testing,” resulting in around 140,000 animal deaths, the organization estimates.

PISC adds that the agency’s updated report issued last year provides “further documentation” corroborating its concerns that non-animal testing methods are not being employed by REACH registrants wherever possible ([A#02140616003]).

PETA UK filed a complaint with the European Ombudsman in 2012 after efforts to engage ECHA on the subject and secure commitments from the agency to address the perceived overuse of animal testing, according to PISC.

While animal testing is prohibited for finished cosmetics and cosmetic ingredients marketed in Europe under the EU’s Cosmetics Regulation, ECHA issued a clarification in October 2014 highlighting exceptions to the ban for cosmetic ingredients subject to REACH requirements. The communication was met with outrage from animal-welfare groups, which claimed that “in practice, the animal test bans would have virtually no application” under such a reading of the laws Also see "ECHA Clarifies Exceptions To Cosmetic Animal-Test Ban; NGOs Regroup" - HBW Insight, 30 October, 2014..

ECHA’s Approach ‘Excessively Restrictive’

The European Ombudsman investigates complaints alleging maladministration in the EU’s institutions and bodies, representing “a useful alternative remedy to the courts,” according to the office’s website. While the ombudsman’s rulings are not legally binding, high compliance among European authorities has been recorded on an annual basis.

In 2013, ECHA was 100% compliant with proposals from the ombudsman’s office, according to the latter’s most recent “Putting It Right?” report.

In her decision on the PETA complaint, issued Dec. 11, 2014, current Ombudsman Emily O’Reilly found that “indeed, ECHA’s interpretation of its obligations was excessively restrictive.”

Specifically, she determined that ECHA’s compliance checks – which the agency is required to conduct on at least 5% of registration dossiers under REACH as a preliminary to substance evaluation – afford opportunity to ensure that companies are complying with the last-resort mandate for animal testing.

The agency argued in its response to PETA’s complaint that compliance checks of registrant dossiers are assessed to confirm that standard information requirements are met, whether or not they were addressed via animal testing or alternative strategies.

The procedure’s scope is limited, and registrants are not obligated to provide ECHA with information that would enable it to determine compliance with REACH’s last-resort animal-testing provision, according to the agency.

The European Ombudsman disagrees, however, that compliance checks are intended only to assess the completeness of submitted data without any consideration of how the data was generated. Operating on this assumption “would amount to informally amending a piece of EU legislation without any involvement whatsoever of the legislator,” O’Reilly asserts.

She maintains that ECHA is in a position to verify whether data in registrant submissions stemmed from “potentially illegal” animal tests.

O’Reilly recognizes that the agency may not have information at its disposal to conclude that a firm conducted animal testing unnecessarily. “Ascertaining whether an alternative method to obtain the relevant information existed is indeed a complex task which requires extensive technical, scientific and even market knowledge,” she notes, recognizing ECHA’s limited resources and knowledge of particular substances and available tests “despite its immense expertise in the chemicals industry.”

However, ECHA is authorized to request such information from registrants and direct firms to complete their dossiers with compliant (non-animal) data when necessary, the ombudsman notes.

“The ombudsman thus considers that it is for the registrants to demonstrate to ECHA, upon request, that the data obtained though animal testing could not reasonably have been obtained though alternative methods,” she states.

In fact, while REACH does not require companies to submit such information from the outset, “diligent” registrants should be prepared to offer their rationale for performing animal tests and “why [they] believed that no non-animal method was apt to provide the same information,” O’Reilly says.

ECHA maintains that due to the length and complexity of the compliance check decision-making process, “which takes more than two years and involves multiple actors,” compliance checks may not always be the most effective means of identifying potential animal-testing violations.

Both PETA and the ombudsman agreed that direct contact with registrants and cooperation with relevant enforcement authorities in member states could prove more efficient in certain cases than the formal drafting of proposals and feedback-gathering protocol required by compliance checks.

The friendly solution proposal was massaged accordingly to provide ECHA with flexibility in its options for verifying compliance with animal-testing provisions in REACH, while identifying compliance checks as the primary tool intended for those purposes.

In a March 5 email, an ECHA rep said the agency has “already started identifying cases where a compliance check could be meaningfully used to address potential noncompliance” with respect to animal testing. “It remains to be seen whether the member states and the Member State Committee,” which weigh in on the agency’s proposals, “will support any draft compliance-check decision resulting from this effort,” he noted.

Enforcement Still Falls To Member States

The European Ombudsman agrees with ECHA that the agency has neither the legal authority to reject REACH submissions on the basis of a non-compliant animal test, nor the resources to investigate every possible instance of non-compliance with the last-resort principle under REACH, as urged by PETA.

In cases where a registrant chooses not to honor a request from ECHA for additional or compliant information, the agency must and should rely on member states to investigate the matter and sanction the firm accordingly, O’Reilly says.

She advises ECHA “to always inform member states of possible instance of noncompliance with REACH, not only of proven violations, in order to facilitate their enforcement tasks.”

At the same time, the ombudsman says the chemicals agency’s limited authority “in no way impedes ECHA from effectively checking compliance with the last-resort principle.” She notes “it is highly unlikely for a registrant to refuse to provide the data required by ECHA and expose itself not only to investigations by the competent member state, but also to a potentially stricter attitude of ECHA in the context of future registrations.”

The ECHA spokesman said the agency has and will continue to inform member states of possible noncompliances in the area of animal testing, prioritizing cases where registrants have provided data based on new animal tests that were not first submitted as proposals and approved.

“With regard to these efforts, we will publish a report on our findings by summer 2015,” the rep said.

Meanwhile, the agency will continue to remind registrants of their responsibilities regarding animal testing and continue working to promote use of alternative methods, he added.

While the ombudsman has accepted the chemicals agency’s response and closed the case, the ECHA rep noted that “any changes in dossier evaluation must be done in agreement with the [EC] and the member states.” ECHA will bring the issue on addressing compliance with REACH’s animal-testing provisions to the attention of the EC, it said, but “the results of these discussions remain to be seen.”

PISC welcomed the ombudsman decision as a “victory” with “enormous implications for preventing the suffering of millions of animals” under REACH, or what the group is calling “the world’s largest animal testing program.”

The organization notes that firms already are preparing and submitting dossiers toward the next REACH deadline – May 31, 2018 – for manufacturers and importers of chemicals in low volumes Also see "ECHA Launches REACH 2018 Web Portal For Low-Tonnage Registrants" - HBW Insight, 20 October, 2014..

The organization is lobbying for Parliamentary measures to ensure that the ombudsman’s recommendations are implemented, that suitable penalties are being imposed on firms by EU members states for breaches of animal-welfare provisions in REACH law and that guidance is required of ECHA in a timely fashion to reflect developments in its dossier review protocol.

PISC notes that it has published its own detailed guidance on minimizing animal testing under REACH.

ECHA May Be Stickler In 2018 For ‘Last Resort’ Animal Tests Only

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