EU sets rules demanding extra data on nanoparticles in mineral-based chemicals

By IM Staff
Published: Thursday, 20 December 2018

Updated European regulations on the nanoparticles content of chemicals will come into force from January 2020.

Manufacturers and users of chemicals made from minerals and chemical mineral processing agents within the European Union, will from January 2020 have to check whether the chemicals they use contain nanoparticles. If they do, they will have to assess their safety and report the results to the European Chemicals Agency (ECHA).

This follows the release of a new EU regulation on nanoforms amending the EU chemical control system known as Registration, Evaluation, Authorisation and Restriction of Chemicals (Reach) which will apply to all current Reach-registered chemicals and any subject to new registration applications. The law has been passed after the EU concluded that nanoforms of chemicals could have different environmental health impacts than chemicals delivered in standard-sized particles.

The new regulation’s preamble said: "Manufacturers and importers should assess and where relevant, generate the necessary information and document in the chemical safety report that the risks, arising from the identified uses of the substance with nanoforms they manufacture or import, are adequately controlled."

An ECHA statement added: "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. This information will help authorities in the EU to identify if further risk management measures are needed."

While basic minerals themselves, as they occur in nature, are not subject to Reach registration (although they may be covered by other Reach usage controls – for instance asbestos), those that have been chemically changed are, such as antioxidants, binders and chelating agents. For instance, clay mineral hectorite and related substances are subject to registrations on Reach, along with synthetic minerals.

Under the new regulation, manufacturers, producers and importers of these mineral-based substances will have to check whether they are supplying them in nanomaterial form – to be covered by the new rules – particles must be between 1 nm (nanometer) and 100 nm. Downstream users of mineral-based chemicals, or mineral processors using chemicals, may also have a role to play here, according to the regulation’s preamble, because a use of nanoforms may potentially change one nanoform into another form, or generate a new nanoform.

As a result: "Downstream users should provide this information up the supply chain to ensure that the use is adequately covered by the registration dossier of the manufacturer or importer, or alternatively cover the specific use in their own chemical safety report," the regulation said.

Information could include data such as nanoforms’ rate of dissolution in water as well as in relevant biological and environmental media. Moreover, unless human exposure is unlikely, tests for toxicity should assess the impact of inhaling nanoparticles, the regulation says.

This would require in workplaces that information on dustiness should be provided regarding any nanoforms under consideration. And for inhalation tests on short term repeated dose and sub-chronic toxicity of such nanoforms, testing should always include microscope examination of brain, lung tissues, and lung fluids, following Organisation for Economic Co-operation and Development (OECD) technical guidance.

As for testing for mutagenicity, because of concerns that some 'in vitro’ gene mutation studies in bacteria might not work, one or more other in vitro mutagenicity tests assessing mammal cells or other internationally recognized in vitro methods should be undertaken, the guidance said.

Detailed assessments will be needed to ensure compliance, with minimum characterization information required in submissions to the regulator: "Particle size, shape and surface properties of a nanoform may influence its toxicological or ecotoxicological profile, exposure as well as behavior in the environment," notes the law.

All different nanoforms covered by the registration must be considered by registering company when assessing their safety, with information on manufacture, use of and exposure to different nanoforms should be provided separately, added European Commission (EC) guidance within the regulation preamble.

That said, it adds that it should be possible to group nanoforms with similar characteristics in sets, to ease the administrative burden. These should be provided in ranges of values "that clearly define the boundaries of the set of similar nanoforms," says the regulation, which adds that when a mineral chemical supplier defines such groups, it should explain how any variation within these parameters will not affect a nanoform’s hazard, exposure and risk assessment.

In any case, test conditions will have to be documented and justified scientifically, including the use of other evidence outside any direct testing to assess the safety of these mineral-based chemical nanoforms.

The law was approved as secondary legislation by the EC, without a formal vote by the European Parliament and EU Council of Ministers – although it has been discussed by specialist committees with national government representatives.

Given its implementation date, should the United Kingdom exit the EU as planned under the draft withdrawal deal due to be discussed by the House of Commons in early January, British compliance with this regulation would be subject to final EU-UK relations negotiations, which would be staged after March 29, 2019.

*See new regulation text

*See full guidance on mineral exemptions to Reach



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