Europe Reach Regulation for Various Sectors

According to the European Commission (EC), nanotechnology is a key enabling technology (KET). It is an enabling technology that has applications in a wide range of industries, including chemicals, consumer goods, health, energy, and the environment. As a result, the European Union's (EU) regulatory framework, which is made up of various pieces of horizontal and sector-specific law expressly or implicitly encompasses nanomaterials (NMs).

The word "nanomaterial" has been defined in several regulatory papers in the European Union, including an overall nonbinding recommendation made by the EC in 2011 and several sector-specific pieces of legislation. The latter have either incorporated the overall definition established by the European Commission or utilise a dedicated and, to some degree, separate meaning of the word.

European Chemicals Agency (EU)

The European Chemicals Agency (ECHA) works closely with the OECD by participating in and participating in ongoing international regulatory activities such as the OECD Working Group on ENM. ECHA houses the EU Nanomaterials Observatory and the Nanomaterials Expert Group (ECHANMEG), and this advisory group assists in the implementation of the ECHA Nanomaterials Work Plan, 2016, 2018. Provides scientific and technical information and advice on issues related to the implementation of REACH methods related to ENM. No ENM exposure limits have been established for this agency and are only recommended by the European Union.

The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH, 2018) is an EU regulation created to protect human health and the environment from the risks posed by chemicals. REACH applies to substances on the nanoscale according to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 and the general provisions of REACH apply.

All chemicals covered by REACH must be registered in order to be lawfully produced or imported into the EU. Manufacturers and/or importers must provide information on both human health and environmental consequences, as well as hazardous nanoforms – an assessment of exposure throughout the life cycle – as part of their registration, depending on the amount placed on the market.

The same rules apply to nanomaterials. When chemicals have hazardous qualities, the Classification, Labelling, and Packaging Regulation (CLP) requires them to be reported to ECHA as well as labelled and packed so that they may be used safely.

Companies should be upfront in their REACH registration, explicitly indicating how the safety of nanoforms has been handled, as well as what actions are required to appropriately limit the possible danger. Companies can get more help from ECHA guidance materials on how to identify and report the attributes of their nanoforms.

Directives are primarily used in the EU to enact environmental, labour, and consumer protection legislation. If nanoparticles represent a risk to the environment, employees, or consumers, the generic regulations established by law apply to nanomaterials in the same manner that they do to other forms of a chemical.

Because REACH and CLP apply to nanomaterials, industry and authorities must fulfil their obligations and carry out their tasks in accordance with the various REACH (e.g., registration, evaluation, authorisation, and restrictions) and CLP processes (e.g., classification and labelling) for nanomaterials, just as they do for any other form of a substance.

To that end, ECHA has been collaborating closely with major EU and worldwide regulatory authorities to develop enough scientific and regulatory capability.

In its second Regulatory Review of Nanomaterials, the European Commission determined that REACH provides the appropriate framework for risk management of nanomaterials when they appear as chemicals or combinations.

Companies that make or import nanoforms must comply with specified legal restrictions under REACH as of January 1, 2020.

These reporting obligations address specific information requirements outlined in revised REACH annexes:

• characterisation of nanoforms or sets of nanoforms covered by registration (Annex VI);

• chemical safety assessment (Annex I);

• registration information requirements (Annexes III and VII-XI); and

• downstream user obligations (Annex XII).

The changes apply to all new and existing nanoform registrations.

Different categories can be assigned to a material based on its size or shape. When reviewing available information for categorization purposes, one must evaluate the forms or physical states in which the chemical or mixture is placed on the market and in which it may reasonably be expected to be utilised.

- A Chemical Safety Assessment (CSA) recorded in a Chemical Safety Report (CSR) is required under Annex I of REACH for production/import volumes of 10 tonnes or more per year. This involves a hazard evaluation, and if the chemical fits the categorization and labelling standards, an exposure assessment, which includes the development of exposure scenarios, and lastly a risk characterization.

- Even if the substance does not fit the above-mentioned criteria, a registrant may choose to build exposure scenarios in order to define and execute how he manages the nanomaterial at his own site and encourage downstream users to control exposures to human health and the environment.

- Nanomaterials' behaviour and impacts are influenced by a variety of factors, including size, number concentration, surface area, charge, and total surface reactivity.

- These features must be considered when assessing risks to human health and the environment. Additional testing or information may be necessary to address the unique dangers related with nanoparticles. Current test criteria may need to be updated in order to detect particular dangers connected with nanomaterials

Special considerations for a set of tests and standards have been stated based on EU legislation for food-related nanotechnology applications (ESFA, 2011).

Another aspect of nanomaterial’s regulation is the economic parameters for using nanotechnology in commercial products. Producing smart composite packaging material with nanoparticles, for example, incurs significant costs. It's difficult to meet regulatory standards because it has a low profit margin.

The EU's labelling obligations for nanomaterials found in food should be mentioned (European Parliament and Council, 2011, 2012). When employed in culinary applications, inorganic nanoparticles require greater consideration due to their possible toxicity. Carbon black, titanium nitrate (TiN), and silicon dioxide nanomaterials are authorised for use in food packaging under EU laws. Silver, aluminium, zinc oxide, and clay nanoparticles, on the other hand, have not been approved.

The European Commission has created strategic action plans and entities for nanoscience and nanotechnology applications (EC, 2010a, b). The possible dangers of nanoparticles employed in industrial products were revealed by EFSA in its "Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain." Furthermore, physicochemical features, surface morphology, chemical content, and potential exposure levels must all be determined in order to assess the danger of such materials (EFSA, 2011a, b).

The necessity for suitable and validated testing procedures and methods for reliable nanomaterial identification and characterisation prompted stakeholders to conduct additional research and evaluation to reduce uncertainties (FAO/ WHO).

The number of nanoparticles that can be used directly in food or integrated into packaging materials is regulated by EU legislation. Migration research data and any health hazards should be reported for packaging applications (EC, 2004, 2007). According to the European Commission (2013), all food additives in the form of engineered nanomaterials must be listed on food labels. The words "nano" in brackets must appear after the names of those substances (FAO/WHO).

The main regulatory framework for cosmetics in the EU is EU Regulation 1223/2009. Based on this structure, a list of all NMs used in cosmetics should be available to all consumers. Most recently (i.e., October 2019), the EU updated the existing guidance on nanomaterials in cosmetics with the Guidelines for the Assessment of Safety of Nanomaterials in Cosmetics by the SCCS (SCCS/1611/19). SCCS provides industry guidance to government agencies to comply with the EC 1223/2009 requirements for the safety assessment of NMs for use as cosmetic ingredients. In accordance with the 2012 guidelines SCCS/1484/12, a complete ban on animal testing under the Cosmetics Regulation came into effect from March 2013, and alternative methods have been used to evaluate the safety of cosmetic ingredients (including NM testing) since then.

In Europe, safety evaluation is mandatory for all cosmetic ingredients. The same goes for nanomaterials used in cosmetics. By the end of 2018, less than 1.5% of cosmetics listed in the CPNP were declared to contain nanomaterials. According to Regulation (EC) No 1223/2009, cosmetic products must indicate whether they contain NM. Even if the NM used is not described in the regulations (which includes most nanoscale dyes, UV filters and preservatives), special procedures must be followed. In case of doubt, the European Commission may request further investigation by the SCCS. The European Commission must approve the use of nano-ingredients in cosmetics. In terms of labelling, all NMs must be listed on the cosmetic label, starting with the name of the chemical followed by the word (nano) in parentheses. The latest updated Cosmetics NM Catalog states that the catalog is "for informational purposes only and is not an expressly permitted list of nanomaterials". So far, the EU has permitted the use of NMs as UV filters containing (nano) TiO2, ZnO, MBBT and trisbiphenyltriazine. Carbon black (nano) can also be used as a colorant in cosmetics. The EU published a catalog of all NMs used in cosmetics in the EU in 2017 and was last updated in December 2019.

In May 2012, the Regulation on the marketing and use of biocidal products was enacted. The European Chemicals Agency oversees the biocidal product authorization procedure. The definition of the word "nanomaterial" provided by the European Commission has been integrated into the text (Article 3, 1z). Nonetheless, the Commission will have the authority to change the meaning of the word considering technological and scientific advancements (Article 3, 5).

The law prohibits the use of the most hazardous compounds and recognises the dangers that nanomaterials may bring. The language defines how active compounds can be approved and specifies that active substance approval does not apply to nanomaterials unless they are specifically acknowledged (Article 4).

In order to react to the special features of nanomaterials, Annex II mandates that the scientific suitability of standard test techniques, or their adaptation to nanomaterials, be explained. The requirements for receiving an authorization are outlined in Article 19. When nanoparticles are employed in biocidal products, the environmental, human, and animal health risks must be addressed independently.

There is no streamlined authorization procedure for biocidal products using nanomaterials, according to Article 25. When test techniques are used to nanoparticles, a description of their scientific suitability for nanomaterials, as well as the technological modifications or alterations performed to respond to the unique properties of these materials, must be supplied (Annex III). The regulatory language also includes rules for labelling treated items before they are placed on the market. The names of all nanomaterials found in biocidal products must be included, followed by the term "nano" in brackets, according to the guidelines (Article 58, 3d).