Impact assessment on Possible amendments of Annexes to REACH for registration of nanomaterials

A. Need for action

Why? What is the problem being addressed? Maximum 11 lines

As any other chemicals, nanomaterials are used in different products, addressed by various legislation, most importantly REACH. Jointly they should provide adequate information on their safe use. There is however a lack of clarity on how nanomaterials should be addressed and safety demonstrated in REACH registration dossiers. The information requirements depend on the total tonnage in which a substance (in all forms) is placed on the market. The information to demonstrate safety may depend on the form of a substance, and although the dossier structure allows it and ECHA encourages it, there is no explicit requirement in REACH to identify such different forms, undertake specific tests for different forms or to justify why the information provided is valid for all forms. Based on an evaluation of registration dossiers submitted by 2010 for substances that exist also in nanoforms, the Commission identified the need for more specific requirements on how nanoforms should be addressed in registration dossiers. In case of inaction, the observed insufficient demonstration of safe use for nanoforms might continue, resulting in increased risk for health and environment due to potentially poor risk management and safety measures, and companies wishing to register nanoforms will face uncertainties, resulting in ineffective implementation and increased costs, affecting innovation, investment decisions and competitiveness.

What is this initiative expected to achieve? Maximum 8 lines

REACH aim is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances (mainly to reduce animal testing), as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. In line with the aim of the legislation, the objective of this initiative is to ensure clarity on how nanoforms of a substance are to be addressed and safety to be demonstrated in registration dossiers, thus allowing REACH to be fit for the purpose of dealing with nanomaterials. This will in turn enable REACH to play its part, as for other chemicals, in supporting availability of adequate information on safe use of nanomaterials.

What is the value added of action at the EU level? Maximum 7 lines

Regulation (EC) No 1907/2006 on REACH is an EU Regulation based on Article 114 TFEU. REACH sets out the registration obligations for chemicals that are placed on the EU market and provides rules for their free circulation, including the manufacture or use of nanoforms of a substance. Legislative initiatives in Member States pertaining to the placing on the market of substances, including their nanoforms, would be in breach of REACH. The possible modification of the provisions established in REACH can only be adopted at EU level.

B. Solutions

What legislative and non-legislative policy options have been considered? Is there a preferred choice or not? Why? Maximum 14 lines

Further to the no-change scenario (option 1), several other options have been considered, each consisting of a set of specific measures, most of which could be evaluated individually. Option 2 would introduce changes to the information requirements of various REACH Annexes clarifying explicitly what the European Chemicals Agency (ECHA) considered, up to Board of Appeal Decision of 2 March 2017 on titanium dioxide, to be the implicit requirements of REACH. Option 3 would introduce measures of soft law nature to provide more clarity on the registration obligations through guidance without any changes to REACH Annexes. Option 4 assumes full implementation of option 2 and would introduce additional measures to demonstrate safe use in cases where the existing information requirements in REACH are not tailored for nanoforms of a substance or where specific considerations are required for them. Option 5 would clarify registration obligations and reduce certain information requirements based on the explicit assumption that the information in a registration dossier for a substance is independent of its form. Option 6 assumes full implementation of options 2 and 4 and would require the generation of comprehensive information about any potential specific effects and extensive additional testing for nanoforms of a substance with the objective of reducing any uncertainty. The preferred option is a mix of measures based on a slightly adapted option 2 and including specific measures from options 4 and 6 further chosen to maximize effectiveness, efficiency and coherence of the action taken. During discussion with the Member States in the REACH committee, some of the measures of this option were modified or extended.

Who supports which option? Maximum 7 lines