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EU Commission adopts REACH nano changes

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The European Commission has adopted revisions to REACH annexes to address substances in nanoforms.

The amendments clarify the information manufacturers or importers must provide in their registration dossiers if they are placing such substances on the market. The new rules will apply from 1 January 2020.

Since coming into force in 2007 REACH has applied to nanomaterials but without containing specific provisions for them. This is why, according to the Commission, companies often did not know how to register these ‘substances in nanoform’. Scientific evidence has shown that their toxicity as well as their effect on the environment often differs from the conventional form of the substance.

The new requirements will enable both companies and authorities to "systematically" assess the hazardous properties of nanomaterials, how they are used safely, and what risks they may pose to our health and the environment, Echa said in a recent press release. This information will help EU authorities to identify if further risk management measures are needed.

The agency said it "strongly encourages" registrants of the substances to familiarise themselves with the amendments and assess what action they need to take.

Echa is also currently deciding whether it needs to update existing, or issue new, guidance to help registrants comply with the new requirements, it said.

Industry approval

Trade bodies broadly welcomed the revisions earlier this year, with Cefic saying in May that they help to create a more "predictable" regulatory environment for industry to innovate and use nanomaterials.

This will ensure the substances are treated in "a standardised way" and bring more clarity to companies on how to provide adequate information within the REACH framework, it added.

However, Cefic also reiterated its concerns that while annex revisions have been approved and are due to enter into force in 2020, the process for revising the Commission's Recommendation on the nanomaterial definition is still ongoing.

NGO the Center for International Environmental Law (Ciel) said, also in May, that the amendments were "far from perfect".

The challenge, Ciel’s David Azoulay added, is how they are implemented and how compliant registrants are. "Will they continue to use every possible excuse to limit the amount of information they provide to Echa as they have been doing for years, or will they finally accept to put the safety of their product under the scrutiny of the agency?"

Information sharing

In June last year Echa launched its EU observatory for nanomaterials (EUON) – a public website aimed at increasing transparency of information. It opted for this rather than to create an EU nano register.

A recent report commissioned by the EUON said companies should share 'sensitive' data on how they produce and use nano-sized pigments to help build exposure scenarios for risk assessments.

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