Overview of REACH information requirements and available methods

Os pigmentos são produtos químicos insolúveis, orgânicos ou inorgânicos, que servem para dar cor a diferentes produtos no mercado da UE. São compostos por vários produtos químicos, e alguns dos quais são nanomateriais. A dimensão das partículas dos pigmentos pode desempenhar um papel importante nas propriedades destes produtos químicos.

Os nanomateriais, tais como as partículas de ouro coloidal para fins de coloração do vidro, são utilizados há centenas de anos e podem ser encontrados nos vitrais de muitos edifícios históricos em toda a Europa. Os pigmentos de nanomateriais podem ser encontrados em diversos produtos, tintas, revestimentos, tintas de impressão e cosméticos.

A classificação de um pigmento como nanomaterial constitui um importante desafio científico e regulamentar, como é o caso dos nanomateriais em geral. A colocação de pigmentos no mercado da UE, incluindo os pigmentos de nanomateriais, é regida por vários regulamentos, incluindo o Regulamento REACH e, se for caso disso, a regulamentação da UE relativa aos produtos cosméticos e alimentos, entre outros.

 

Lista de nanopigmentos no mercado da UE

No âmbito de um estudo encomendado pelo EUON para investigar a utilização segura de pigmentos nanométricos em produtos de consumo, bem como a sua segurança quando utilizados por profissionais e trabalhadores, foi criada uma lista de pigmentos nanométricos existentes no mercado da UE.

A lista é constituída por 81 substâncias provenientes da base de dados da Agência Europeia dos Produtos Químicos (ECHA), bem como de publicações dos inventários nacionais da Bélgica e da França, e do atual catálogo de nanomateriais utilizados em produtos cosméticos da UE. Foram igualmente utilizados dados do Registo de Produtos Dinamarquês. Clique nos nomes das substâncias da lista para obter mais informações provenientes da base de dados de produtos químicos da ECHA.

Last update: 8 October 2019


Endpoint


REACH ANNEX


Explanation of the change for nanomaterials


ECHA Guidance

Overview of methods/standards/protocols

PHYSICO-CHEMICAL PROPERTIES

Number based particle size distribution with indication of the number fraction of the constituent particles in the size range 1-100 nm

VI

Characterisation parameter for nanoforms and sets of nanoforms.

Covered by the guidance for registration of nanoforms/sets of nanoforms.

Currently under development within OECD WNT project 1.4 for new test guideline (supported by Malta Initiative);

Advice in the guidance on nanoforms and sets of nanoforms that is aligned with the OECD draft guideline as far as possible.

Description of surface functionalisation or treatment and identification of each agent including IUPAC name and CAS or EC number

VI

Advice in the guidance on nanoforms and sets of nanoforms.

For the time being, it is possible to use protocols from research projects and/or general techniques which is taken into account in current ECHA guidance.

OECD WNT project 1.6 for guidance document (Malta Initiative) under development from 2019.

Shape, aspect ratio and other morphological characterisation: crystallinity, information on assembly structure

VI

Advice from OECD WNT project 1.4 for new test guideline currently under development (supported by Malta Initiative) on particle size regarding determination of length and aspect ratio for fibres (elongated particles). 2D nanomaterials not covered by the test guideline.

Currently, there are protocols from research projects and/or standard methods and/or scientific literature available for determination of crystallinity/assembly structure. 

 

Specific surface area (volume or mass)

VI

ISO/TR 14187 provides an introduction to (and some examples of) the types of information that can be obtained about nanostructured materials using surface-analysis tools. Of equal importance, both general issues or challenges associated with characterising nanostructured materials and the specific opportunities or challenges associated with individual methods are identified.

WNT Project 1.3 for new test guideline (Malta Initiative) finalisation expected by 2021 however, based on the same techniques as the ISO standard.

7.7 Solubility

VII

Dissolution rate to be determined also.

Assessment of dispersion as confounding effect.

Partially already covered in guidance released in 2017 where it is mentioned as an important factor to consider by e.g. the use of existing guidelines for metals.

WNT Project 1.5 for new guidance document/test guideline (Malta Initiative).

WNT Project 3.10 new test guideline on dissolution of metal nanomaterials in aquatic media.

Development of an OECD guidance document on agglomeration and dissolution behaviour in aquatic media, expected to be available presumably in 2020 (WNT project 3.9).

Cross cutting issues to be considered with dissolution/solubility in PC, human tox, environmental tox, environmental transformation as well as how it is addressed in specific test guidelines.

7.8 Partition coefficient octanol/water

VII

Dispersion stability to be considered when Kow is not applicable.

Partially already covered in guidance released in 2017 where it is recommended.

OECD test guideline 318 is available for dispersion stability but is not offering advice on differentiation between dissolution and dispersion.

In addition, a guidance on dissolution rate and dispersion stability is expected presumably in 2020 (WNT project 3.9).

7.14 bis Dustiness

VII

New information requirements for nanoforms

 

CEN standards are available as of autumn 2018.

WNT Project 1.8 new guidance document/test guideline on dustiness (Malta Initiative).

7.19 Further information on physchem properties

IX

Information that influences hazard or exposure for the nanoforms.

Partly covered by the read across guidance for nanoforms of the same substances.

OECD decision tree for physical chemical characterisation is avaiable.

OECD framework on physical chemical characterisation was released in May 2019 and can be used indicatively for assessing relevance and applicability of existing methods/standards.

In addition WNT Project 1.7, an OECD test guideline (Malta Initiative) a test guideline on hydrophobicity is under development, which can be used to provide further information on physical chemical properties.

ISO/TR 11360:2010 describes a classifying system, termed a “nano-tree”, upon whose basis wide ranges of nanomaterials can be categorized, including nano-objects, nanostructures and nanocomposites of various dimensionality of different physical, chemical, magnetic and biological properties.

HUMAN HEALTH

8.4.1. In vitro gene mutation study in bacteria

VII

Consider mammalian cell study instead (if not appropriate)

Mostly covered in guidance update of 2017.

Relevant OECD test guidelines to be reviewed (Malta Initiative). Alternative methods available such as the use of mammal cell lines.

8.5.1 Acute toxicity by oral route

VII

Use the most appropriate route of exposure (e.g. 8.5.2 or 8.5.3).

Clear statement in the legal text minimising the need for additional guidance.

Not applicable

8.5 Acute toxicity

VIII

Second route (choose most appropriate).

8.6.1 Short-term repeat dose toxicity

VIII

Toxicokinetics including lung clearance.

Further studies may be needed (indirect genotox).

Partially already covered in guidance released in 2017.

Currently no specific concern about the use of existing method. Sample preparation guidance offers support.

Additional studies may be challenging as no specific studies are prescribed.

8.6.2 Sub-chronic

IX

8.6.3

X

(long term repeated toxicity study proposed > 12 months) For nanoforms: physchem properties to be taken into account when assessing the need of a long-term study.

 

The need to consider physchem properties of nanoforms when conducting tests is acknowledged for all annexes.

8.8 Toxicokinetics

8.8.1 Assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information

VIII

Perform if 8.8.1 not available

Limited advice on the aspect of toxicokinetics for nanoforms is provided in the 2017 guidance update.

ISO/TR 22019:2019 Nanotechnologies — Considerations for performing toxicokinetic studies with nanomaterials. This document describes the background and principles for toxicokinetic studies relevant for nanomaterials. Annex A shows the definitions for terminology with respect to toxicokinetics as used in OECD TG 417:2010. This work will also feed into the work on existing OECD test guideline 417. Draft not foreseen to be ready before 2023.

Development of new test guideline on toxicokinetics to accommodate testing of (nano)particles has been initiated by the Netherlands. The initiative of NL is part of the Malta Initiative and is now project proposal at WPMN level.

ENVIRONMENT

9.1.1. Short term toxicity in invertebrates

VII

Waiver based on solubility (only) not acceptable for nanomaterials.

Consider nanomaterials also dispersion stability.

High dissolution rate or low dispersion stability can be used to justify that short-term testing is sufficient.

Partially already covered in guidance released in 2017.

The OECD Test guideline on dissolution rate, and OECD Guidance document on dissolution rate and dispersion stability are most likely needed in the vast majority of cases.

WNT Project 2.51 An OECD Guidance Document on aquatic and sediment toxicity testing to be adopted and available either end of 2019 or 2020.

ISO/TS 20787:2017 specifies a test method, aiming to maximize repeatability and reliability of testing, to determine whether MNMs are toxic to aquatic organisms, specifically Artemia sp. nauplius.

ISO/TS 20787:2017 is intended to be used by ecotoxicological laboratories that are capable in the hatching and culturing of Artemia sp. and the evaluation of toxicity of nanomaterials using Artemia sp. nauplius.

This method uses Artemia sp. nauplii in a simulated environment, artificial seawater, to assess effects of nanomaterials.

ISO/TS 20787:2017 is applicable to MNMs that consist of nano-objects such as nanoparticles, nanopowders, nanofibres, nanotubes, nanowires, as well as aggregates and agglomerates of such MNMs.

9.1.2. Grow inhibition study on aquatic plants

VII

Waiver based on solubility (only) not acceptable for nanomaterials.

Consider nanomaterials also dispersion stability.

9.1.3 Short term toxicity testing on fish

VIII

Waiver-based on solubility (only) not acceptable for nanomaterials.

Consider nanomaterials also dispersion stability.

High dissolution rate or low dispersion stability can be used to justify that short-term testing is sufficient.

9.1.4 Activated sludge respiration inhibition testing

VIII

Waiver-based on solubility (only) not acceptable for nanomaterials.

Consider nanomaterials also dispersion stability.

9.2 Degradation

VIII

For nano consider morphological, chemical other and changes on shape size, etc.

WNT 3.16 Project on GD/TG for Transformation (lead AT) An OECD Guidance Document on transformation of NMs is under development. This Guidance Document aims to cover abiotic core transformation and coating degradation (Malta Initiative). Both documents likely to be available around 2023/2024. It may be possible to conduct a qualitative assessment in the meantime.

9.2.2.1 Hydrolysis as function of pH

VIII

Waiver-based on solubility (only) not acceptable for nanomaterials.

Consider nanomaterials also dispersion stability.

   

9.3.1 Adsorption desorption screening

VIII

Justification required to use Kow, dissolution rate or dispersion stability for waving the study.

Partially already covered in guidance released in 2017.

Draft OECD guidance document on testing nanomaterial behaviour in soils using OECD test guideline 312 is expected in 2020/2021.

9.2.1.2 Simulation testing on ultimate degradation in surface water

IX

Waiver-based on solubility (only) not acceptable for nanomaterials.

Consider nanomaterials also dispersion stability.

   

9.3.2 Bioaccumulation in aquatic species, preferably fish

IX

Justification required to use Kow, dissolution rate etc.

Partially already covered in guidance released in 2017.

WNT Project 3.12 GD for OECD 305 (dietary exposure) (lead SP) expected to be finalised by 2021/2022.

A decision tree (OECD Guidance Document) for tiered testing of bioaccumulation) is under development (lead UK).

9.3.3 Further information on adsorption desorption depending on the results of the study required in Annex VIII

IX

Justification required to use Kow, dissolution rate or dispersion stability for waiving the study.

A draft OECD guidance document on testing nanomaterials behaviour in soils using test guideline 312 (to be adopted presumably in 2020/2021).

A draft OECD test guideline on Manufactured Nanomaterial Removal in Wastewater Treatment Plants: Activated Sludge Sorption Isotherm, could be used as complementary information on sorption in wastewater sludge.

9.4 Effects in terrestrial organisms

IX

Short-term may be sufficient if nanomaterial not persistent and has low potential of absorption to soil.

Potential development or enlargement of the OECD guidance document on aquatic and sediment testing to soil. Still up for discussion and it could be that this in the end is addressed in a separate guidance document.

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