Regulation

In Europe safety of industrial chemicals is regulated in the Regulation (EC) 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances.

Since 2018 the European Regulation (EU) 2018/1881 amends the REACH regulation to address nanoforms. This includes additional requirements for substance identification as well as some further requirements to address the specifics of nanomaterials in their potential impacts on both human health and the environment.

The European Chemicals Agency (ECHA) provides guidance to support registrants to comply to the REACH regulation. Since 2012 this includes specific appendices to the guidance documents that support the registration of nanoforms of a substance and providing further information on their impacts on both human health and the environment. Guidance is regularly updated to include latest scientific progress and insights.

The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.

The European Chemicals Agency (ECHA) provides guidance to support applicants to comply to the Biocidal Products Regulation. For nanomaterials, this guidance also refers to the guidance for REACH.

In the EU the safety of nanomaterial in food products is specifically mentioned under the novel food regulation (Regulation (EC) 2015/2283), the food contact material regulation (Regulation 282/2008/EC), food additives (Regulation 1333/2008/EC) and in food information to consumers (Regulation (EU) 1169/2011). Nevertheless, also other food regulations (e.g., Regulation 1331/2008/EC, Regulation 1332/2008/EC, Regulation 1334/2008/EC) are relevant for nanomaterials.

The European Food Safety Agency (EFSA) provides guidance to support applicants with nanomaterials to comply to the food and feed regulations. But also for materials that contain only a proportion of nanomaterials, the nanospecifics may be relevant. That is explained in a separate EFSA-guidance document.

The EU Regulation on Cosmetic Products (Regulation (EU) 1223/2009) is the main regulatory framework for finished cosmetic products when placed on the EU market. It strengthens the safety of cosmetic products and streamlines the framework for all operators in the sector. It also includes specific provisions for nanomaterials.

Regulatory implementation is supported by guidance documents, written by the Scientific Committee on Consumer Safety (SCCS). The most recent guidelines for nanomaterials in cosmetics are the Notes of guidance for the testing of cosmetics and the guideline for safety assessment of nanomaterials.

The EU Regulation on veterinary medicinal products (Regulation (EU) 2019/6) is the main regulatory framework for veterinary medicinal products when placed on the EU market. The regulation specifically mentions nanotechnology and requirements are laid down in Annex II of the regulation.

The European Medical Agency (EMA) provides further Guidance and Scientific Guidelines to comply to the regulation.

Medical devices are regulated in Regulation (EU) 2017/745. The regulation also includes a definition for medical devices and nanomaterials are specifically mentioned. Further guidance is provided in several ISO documents, most notably ISO 10993/22 on nanomaterials in medical devices.

Before any plant protection products (PPPs) can be placed on the market or used, it must be authorised in the EU country concerned. Regulation (EC) No 1107/2009 lays down the rules and procedures for authorisation of PPPs. PPPs contain at least one approved active substance. These may include micro-organisms, pheromones and botanical extracts. The European regulation on data requirements for active substances in plant protection products (Regulation (EU) 283/2013) lays down the required information for approval. PPP regulation do not specifically mention the term "nanomaterials". Nevertheless, the data requirements should also be fulfilled for nanomaterials. The European Food Safety Authority (EFSA) coordinates the peer-review process of active substances in PPPs. The EFSA guidance for food and feed regulations may therefore also be relevant for PPPs.

The medicinal products for human use are regulated through Directive 2001/83/EC. As this directive is not very descriptive most of the detailed requirements are further described in Guidance and Scientific Guidelines by the European Medical Agency (EMA). The legislation does not specifically mention nanomaterials, but it is expected that nanospecifics are picked up by the detailed scrutiny for medicinal products.

The directive on General Product Safety Directive stands as the main EU legislation providing the framework for the safety of a product which is not covered by specific legislations. The scope of the GPSD is to assure that only safe products are placed on the EU market. This is assured by providing general concepts, establishing the responsibilities of the value chain actors, and by indicating harmonized standards (safety rules), which are methods officially accepted by the EU to evaluate safety of certain products.

The Directive on Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS Directive) identifies hazardous substances that shall not be included in electrical and electronic equipment. The RoHS Directive currently restricts the use of ten substances: lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP). In principle this also includes nanomaterials

The Directive on Waste from Electrical and Electronic Equipment (WEEE Directive) aims to contribute to sustainable production and consumption by preventing the creation of WEEE, contributing to the efficient use of resources and the retrieval of secondary raw materials through re-use, recycling and other forms of recovery, and improving the environmental performance of everyone involved in the life cycle of EEE. In order to achieve these objectives, the Directive requires the separate collection and proper treatment of WEEE and sets targets for their collection as well as for their recovery and recycling, helps European countries fight illegal waste exports more effectively by making it harder for exporters to disguise illegal shipments of WEEE, and reduces the administrative burden by calling for the harmonisation of national EEE registers and of the reporting format.

This category of products covers a broad range of goods, such as upholstery, garments, footwear, home textile, etc. Specific legislations would apply to cover labelling, fibre composition, flammability, etc. and are mainly covered by the Regulation on textile fibre names and the marketing of the fibre composition of textile products. Since nanomaterials may be embedded in the product fibres, these pieces of legislation may also apply even if no provisions for nanomaterials are included, hence manufacturers must take into account the adaptation of key guidelines to nanomaterials while addressing the requirements of these pieces of legislation.

In the United States of America nanoscale materials are assessed within the regulatory framework for chemicals in the Toxic Substances Control Act. An information gathering rule on new and existing nanomaterials is drafted and premanufacture notifications for new nanomaterials have become mandatory.

In Canada nanoscale materials are assessed within the regulatory framework for chemicals in the Canada Environmental Protection Act. In June 2022, a draft Framework for the Risk Assessment of Manufactured Nanomaterials under the Canadian Environmental Protection Act was published. In parallel to developing this Framework the Government of Canada initiated screening assessments of some identified existing nanomaterials.

The Australian Industrial Chemicals Introduction Scheme (AICIS) requires anyone who plans to manufacture or import industrial chemicals (or products that contain industrial chemicals) into Australia for commercial, research or any business-related purposes needs to register to enable assessment and authorisation by the Australian government.

“Korea’s Act on the Registration and Evaluation of Chemical Substances” is the legislation that sets out the rules on how to register, evaluate and safely manage chemicals. Specific requirements are included for nanomaterials.