Insights into possibilities for grouping and read-across for nanomaterials in EU chemicals legislation

Figures & data

Table 1. Overview of legislation for chemicals, biocides, plant protection, cosmetics and food, including how grouping is addressed. (“Risk Assessment” refers to the area of risk assessment addressed under the legislation, which may be HH and/or ENV. HH: Human Health, ENV: Environment, and Fate and behavior, YES: the column header is reflected in the legal text, NO: the column header is not reflected in the legal text, n/a: not applicable).

Area of application legislation	Nano-definition (legal text)/Other information	Grouping explicitly mentioned in legal text	Read-across possible as an alternative method^1	Nano-content labeling	Guidance for grouping	Guidance for grouping of NMs	Risk assessment
							HH	ENV
REACH (EC 2006)	The definition of the term 'substance' implicitly covers all forms at any size. Amended REACH annexes (EC 2018) have been proposed, in which the term ‘nanoform’ is defined. ECHA applies the EC NM Definition for REACH registration purposes (1). Annexes are currently under review to include a definition and nanospecific requirements.	Annex XI	YES	NO	YES	YES	YES	YES
CLP (EC 2008a)	No definition	NO	YES	NO	YES	NO	YES	YES
Sector specific legislation
Biocidal Products (EU 2012a)	Article 3 Definitions (z) ‘nanomaterial’ means a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials. For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows: — ‘particle’ means a minute piece of matter with defined physical boundaries, — ‘agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components, — ‘aggregate’ means a particle comprising strongly bound or fused particles;	YES	YES	YES	YES	NO	YES	YES
Plant protection products (EC 2009a)	No definition	NO	YES (Not for food residues)	NO	YES (For some aspects of the assessment)	NO	YES	YES
Cosmetic products (EC 2009b)	Article 2 Definitions (k) an insoluble or bio-persistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.	NO	YES	YES	NO. Reference to OECD guidance	NO	YES	YES (under REACH)
Food contact materials (EC 2004)	No definition	NO	YES	NO	YES	NO	YES
Plastic food contact materials (EU 2011a)	No definition Regulation (EU) No 10/2011 provides some specifications for engineered NMs: Recital 23 'New technologies engineer substances in particle size that exhibit chemical and physical properties that significantly differ from those at a larger scale, for example, nanoparticles. These different properties may lead to different toxicological properties and therefore these substances should be assessed on a case-by-case basis by the Authority as regards their risk until more information is known about such new technology. Therefore it should be made clear that authorizations which are based on the risk assessment of the conventional particle size of a substance do not cover engineered nanoparticles'. Recital 27: In recent years, plastic food contact materials are being developed that do not only consist of one plastic but combine up to 15 different plastic layers to attain optimum functionality and protection of the food, while reducing packaging waste. In such a plastic multi-layer material or article, layers may be separated from the food by a functional barrier. This barrier is a layer within food contact materials or articles preventing migration of substances from behind that barrier into the food. Behind a functional barrier, non-authorized substances may be used, provided they fulfill certain criteria and their migration remains below a given detection limit…….New technologies that engineer substances in particle size that exhibit chemical and physical properties that significantly differ from those at a larger scale, for example, nanoparticles, should be assessed on a case-by-case basis as regards their risk until more information is known about such new technology. Therefore, they should not be covered by the functional barrier concept. Article 9 Specific requirements on substances (2) Substances in nanoform shall only be used if explicitly authorized and mentioned in the specifications in Annex I. Article 13 Plastic multi-layer materials and articles 4. The substances not listed in the Union list or provisional list referred to in paragraph 2(b) shall not belong to either of the following categories: (a) substances classified as ‘mutagenic’, ‘carcinogenic’, or ‘toxic to reproduction’ in accordance with the criteria set out in sections 3.5, 3.6. and 3.7 of Annex I to Regulation (EC)No 1272/2008 of the European Parliament and the Council(1) OJ L 353, 31.12.2008, p. 1.; (b) substances in nanoform. Article 14 Multi-material multi-layer materials and articles 1. In a multi-material multi-layer material or article, the composition of each plastic layer shall comply with this Regulation. 2. By derogation from paragraph 1, in a multi-material multi-layer material or article a plastic layer which is not in direct contact with food and is separated from the food by a functional barrier, may be manufactured with substances not listed in the Union list or the provisional list.3. The substances not listed in the Union list or provisional list referred to in paragraph two shall not belong to either of the following categories: (a) substances classified as ‘mutagenic’, ‘carcinogenic’ or ‘toxic to reproduction’ in accordance with the criteria set out in sections 3.5, 3.6. and 3.7 of Annex I to Regulation (EC)No 1272/2008; b) substances in nanoform.	NO	YES –but explicitly excluded for nanomaterials	NO	NO	NO	YES
Active and intelligent food contact materials and articles (EC 2009c).	No definition Recital 14 states: '… New technologies that engineer substances in particle size that exhibit chemical and physical properties that significantly differ from those at a larger scale, for example, nanoparticles, should be assessed on a case-by-case basis as regards their risk until more information is known about such new technology. …' Article 5 Community list of substances that may be used in active and intelligent components 1. Only substances which are included in the ‘Community list’ of authorized substances (hereinafter referred to as the Community list) may be used in components of active and intelligent materials and articles. 2. By way of derogation from paragraph 1, the following substances may be used in components of active and intelligent materials and articles without being included in the Community list: … (c) substances used in components which are not in direct contact with food or the environment surrounding the food and are separated from the food by a functional barrier provided that they comply with the conditions set out in Article 10 and that they do not fall within either of the following categories: … (ii) substances deliberately engineered to particle size which exhibit functional physical and chemical properties that significantly differ from those at a larger scale.	NO	NO	NO	NO	NO	YES
Novel foods (EU 2015b)	Article 3 Definitions (f) ‘engineered nanomaterial’ means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale. Properties that are characteristic of the nanoscale include: (i) those related to the large specific surface area of the materials considered; and/or (ii) specific physico-chemical properties that are different from those of the non-nanoform of the same material.	NO		YES (EU) No 1169/2011	NO	NO	YES
Food additives (EC 2008b)	No definition Other information: Article 12 Changes in the production process or starting materials of a food additive already included in a Community list When a food additive is already included in a Community list and there is a significant change in its production methods or in the starting materials used, or there is a change in particle size, for example through nanotechnology, the food additive prepared by those new methods or materials shall be considered as a different additive and a new entry in the Community lists or a change in the specifications shall be required before it can be placed on the market.	NO	YES	YES (EU) No 1169/2011	NO	NO	YES
Food enzymes (EC 2008c)	No definition Other information: Recital12 A food enzyme already included in the Community list under this Regulation which is prepared by production methods or using starting materials significantly different from those included in the risk assessment of the Authority, or different from those covered by the authorization and the specifications under this Regulation, should be submitted for evaluation by the Authority. ‘Significantly different’ could mean inter alia a change of the production method from extraction from a plant to production by fermentation using a micro-organism or a genetic modification of the original micro-organism, a change in starting materials, or a change in particle size.	NO	NO	YES (EU) No 1169/2011	NO	NO	YES
Flavourings (EC 2008d)	No definition	NO	YES	YES (EU) No 1169/2011	NO	NO	YES
Food supplements (EC 2002)	No definition Food Supplements that are also Novel Foods should are covered by both legislations, see requirements for Novel Foods.	NO	NO	NO	NO	NO	YES
Food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control (EU 2013)	Recital 23 When there is a significant change in the production method of a substance that has been used in accordance with this Regulation or a change in particle size of such a substance, for example through nanotechnology, that substance should be considered different from the one that has been used in accordance with this Regulation and should be re-evaluated under Regulation (EC) No 258/97 and subsequently under this Regulation. Article 2 Definitions 1. For the purposes of this Regulation, the following definitions shall apply: (b) the definitions of ‘prepacked food’, ‘labeling’ and ‘engineered nanomaterial’ set out respectively in points (e), (j) and (t) of Article 2(2) of Regulation (EU) No 1169/2011; Other information: Article 9 General compositional and information requirements … 2. Food referred to in Article 1(1) shall not contain any substance in such quantity as to endanger the health of the persons for whom it is intended. For substances which are engineered nanomaterials, compliance with the requirement referred to in the first subparagraph shall be demonstrated on the basis of adequate test methods, where appropriate.	NO	NO	NO	NO	NO	YES
Food information to EU (2011b)	Same as (EU) 2015/2283 Other Information: Article 18 List of ingredients All ingredients present in the form of engineered nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets.	n/a	n/a	YES	n/a	n/a	n/a	n/a

EC 2006. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). OJ No. L396, 30.12.2006, p.1.

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EC 2018. Commission Regulation (EU) …/…of XXX amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances, and ANNEX. 1. Document D056122/02 of 26 April 2018. Available at http://ec.europa.eu/transparency/regcomitology/index.cfm?do=search.documentdetail&Dos_ID=15915&DS_ID=56122&Version=2

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EC 2008a. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (CLP). OJ No. L353, 31.12.2008, p. 1.

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EU 2012a. Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products. OJ L 167, 27.6.2012, p. 1.

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EC 2009a. Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market. OJ No. L309, 24.11.2009, p. 1.

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EC 2009b. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. OJ No. L342, 22.12.2009, p. 59.

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EC 2004. Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC. OJ No. L 338, 13.11.2004, p. 4.

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EU 2011a. Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food. OJ No. L12, 15.1.2011, p. 1.

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EC 2009c. Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food. OJ L 135, 30.5.2009, p. 3.

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EU 2015b. Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011. OJ No. L327, 11.12.2015, p. 1.

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EC 2008b. Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. OJ No. L354, 31.12.2008, p. 16.

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EC 2008c. Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes. OJ No. L354, 31.12.2008, p. 7.

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EC 2008d. Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods. OJ No. L354, 31.12.2008, p. 34.

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EC 2002. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements OJ L 183, 12.7.2002, p. 51.

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EU 2013. Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control OJ L 181, 29.6.2013, p. 35.

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EU 2011b. Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers. OJ No. L304, 22.11.2011, p. 18.

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