INSTITUTION PROFILE / NANOTECHNOLOGY
European Commission
The EU's executive body: it issues the recommended definition of a nanomaterial and proposes and amends laws such as REACH
The European Commission is the executive branch of the European Union. Its main roles include proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU. In nanotechnology it issued the Recommendation on the definition of nanomaterial (2022/C 229/01), adopted the REACH regulation on nanoforms (2018/1881) and funds the EU Observatory for Nanomaterials (EUON). But a Recommendation has no binding force. Whether a definition actually takes effect depends on how each individual law sets out its own definition. The European Chemicals Agency (ECHA), which hosts EUON and handles REACH registrations, is a separate body from the Commission. This profile looks at one question only: how far the Commission's influence over nanotechnology actually reaches, in terms of the kind of power it holds and where that power applies.
What this article covers
- The Commission in 30 seconds
- What kind of body it is: the four types of influence
- What it does for nanotechnology
- How far its influence reaches (powers and geography)
- How a Recommendation relates to law, and who else is involved
- Outlook
- Glossary, references and claim-to-source audit
1. The Commission in 30 seconds
FULL NAMEEuropean CommissionThe executive branch of the European Union
COUNTRY / REGIONEU (Brussels, Luxembourg)Its departments and executive agencies are based in Brussels and Luxembourg
TYPE OF BODYEU executive bodyProposes legislation and implements decisions. Laws are finally adopted by the European Parliament and the Council
COMPOSITION / TERM27 Commissioners, five-year termThe College of Commissioners steers the Commission's political direction
SCALE (PEOPLE)Over 33,000 staffPermanent and contract employees, according to the Commission's own page
SCALE (BODIES)56 organisationsDirectorates-General, service departments, executive agencies and others combined
ROLE IN NANOTECHNOLOGYRecommendation, regulations, fundingThe definition Recommendation, the REACH regulation and funding for EUON
REACHThe EU internal marketREACH requires manufacturers and importers to register, so it also reaches companies that export to the EU
The one point to grasp first
A Commission "Recommendation" has no binding force. Article 288 of the Treaty on the Functioning of the European Union says a regulation is binding in its entirety and directly applicable, a decision is binding in its entirety, and "recommendations and opinions shall have no binding force" Sourced. The Recommendation on the definition of nanomaterial (10 June 2022, 2022/C 229/01) recommends that the Commission, Member States and economic operators use the definition, and its recital 23 states that the definition neither affects nor reflects the scope of application of any instrument of Union legislation Sourced. What actually takes effect is the definition that each law sets out for itself. REACH, for example, writes the concept of a "nanoform" into its annexes through a 2018 Commission regulation, and states that the definition is based on the 2011 Recommendation Sourced. The body that issues the Recommendation (the Commission) and the way each law sets out its definition therefore have to be read separately.
2. What kind of body it is: the four types of influence
The institutions that appear in nanotechnology coverage do not make nanomaterials themselves, unlike companies. They can be grouped into four types by the route through which they influence the field.
3. What it does for nanotechnology
| Area | What the primary sources show |
|---|---|
| Definition Recommendation | Recommendation 2011/696/EU of 18 October 2011 was updated by Recommendation 2022/C 229/01 of 10 June 2022 (Official Journal C 229, 14 June 2022). The 2022 text defines a nanomaterial as a material consisting of solid particles of which 50% or more, in the number-based size distribution, meet at least one condition: (a) one or more external dimensions of 1 nm to 100 nm; (b) an elongated shape with two external dimensions below 1 nm and the other above 100 nm; (c) a plate-like shape with one external dimension below 1 nm and the others above 100 nm. Particles with at least two orthogonal external dimensions above 100 μm need not be considered in the distribution, and a material with a volume specific surface area below 6 m²/cm³ is not considered a nanomaterial |
| REACH nanoforms | Commission Regulation (EU) 2018/1881 (3 December 2018; Official Journal L 308, 4 December 2018) amended Annexes I, III and VI to XII of REACH and added provisions on "nanoforms" of substances. It applies from 1 January 2020. Annex VI defines a nanoform, on the basis of the 2011 Recommendation, as a form of a substance containing particles of which 50% or more in the number size distribution have one or more external dimensions of 1 nm to 100 nm (fullerenes, graphene flakes and single-wall carbon nanotubes are included even below 1 nm), and introduces the idea of a "set of similar nanoforms". In 2020 Annex II (safety data sheets) was also updated by Regulation (EU) 2020/878 |
| Definitions in other laws | The original text of the Cosmetics Regulation (EC) No 1223/2009 (Official Journal L 342, 22 December 2009) defines "nanomaterial" as an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm, and provides that the Commission shall adjust the definition to technical and scientific progress and to definitions agreed at international level (Article 2(3)). The EUON page gives as examples of differing uses that the Biocidal Products Regulation applies the definition to active and non-active substances and extends it to specific materials with dimensions below 1 nm, and that the European Food Safety Authority (EFSA) considers only manufactured nanomaterials, regardless of size distribution, in the food and feed additives context. Whether the Cosmetics Regulation definition has been amended since could not be confirmed |
| Guidance | The Recommendation's recitals say implementation guidance should be developed and kept updated by the Commission's Joint Research Centre (JRC) (recital 8) and that the JRC had already published two implementation guidance reports in 2019 (recital 3) |
| EU Observatory for Nanomaterials (EUON) | Launched in 2017. It collects objective and reliable information on markets and safety aspects of nanomaterials. It is funded by the European Commission and hosted and maintained by ECHA (the Commission's page) |
| Research funding | A three-year EU-funded project, NANOMET (launched in May 2020), supports the OECD's work on nanomaterial test methods (the OECD's page) |
* The exclusion of materials below 6 m²/cm³ is the final "however" sentence of point 1 of the Recommendation.
A materials engineer's view: the same material can fall differently under different laws
The 2022 Recommendation bases the definition on the number-based size distribution and excludes materials with a volume specific surface area below 6 m²/cm³. The "nanoform" in REACH Annex VI, by contrast, is still worded on the basis of the 2011 Recommendation, and the Cosmetics Regulation uses a different wording that refers to insoluble or biopersistent materials and to internal structure Sourced. A manufacturer who has the same powder assessed under several regimes needs to check its size-distribution results against the wording of each law's definition one at a time. Meeting the Recommendation's definition and falling within a particular law are separate checks.
4. How far its influence reaches (powers and geography)
| Dimension | What the Commission has | What the Commission does not have |
|---|---|---|
| Power | The right to propose legislation (Article 17(2) of the Treaty on European Union: Union legislative acts may only be adopted on the basis of a Commission proposal, except where the Treaties provide otherwise). The adoption of Commission regulations that amend the REACH annexes (Regulation 2018/1881 rests on Article 131 of REACH). Recommendations, guidance and research funding | The final adoption of laws (under the ordinary legislative procedure the European Parliament and the Council adopt jointly). Binding force for Recommendations (the Treaty says they have none). The receipt and evaluation of REACH registration dossiers (done by ECHA) |
| Geography | The EU internal market. REACH requires manufacturers and importers to register substances above one tonne per year, so it reaches non-EU companies that export to the EU | Direct effect on the laws of countries outside the EU |
| Scope | Recommending a definition of nanomaterial, REACH requirements on nanoforms, and building up information (EUON) | The power to rule a material "authorised" or "banned" simply because it is nano. The scope of application of individual laws (recital 23 of the Recommendation) |
| Scale | 27 Commissioners, over 33,000 staff and 56 organisations (Commission-wide) | Staffing and budget for nanotechnology alone could not be confirmed on the official pages |
The Commission and ECHA are separate bodies
Within REACH, ECHA (the European Chemicals Agency) is the central body: it manages the databases, coordinates the evaluation of submitted information and publishes hazard information. The Commission is the side that handles proposals for the REACH regulation and amendments to its annexes. EUON is funded by the Commission and hosted and maintained by ECHA. ECHA's own powers and staffing are outside the scope of this article Sourced.
5. How a Recommendation relates to law, and who else is involved
The flow of a definition can be read in four steps: standards bodies supply terms; the Commission recommends a definition; individual laws set out their own wording; and businesses and authorities apply it.
The Recommendation's recitals say that the definition's core terms should be based on existing standardised terms (ISO, CEN) (recital 8) and that "particle" is defined in line with a different ISO standard (recital 15) Sourced.
| Organisation | Relationship that can be confirmed |
|---|---|
| ECHA (European Chemicals Agency) | A separate body at the centre of REACH registration and evaluation. It hosts and maintains EUON. It is not part of the Commission |
| Joint Research Centre (JRC) | The Commission's research service. The Recommendation's recitals say the JRC prepares and updates implementation guidance. In the OECD's 2025 SSIA report, JRC researchers are named among the project co-leads |
| OECD | The Commission-funded NANOMET project supports the OECD's test-method work. The OECD and the European Commission are both listed as liaisons of ISO/TC 229 |
| ISO and CEN | Named in recital 8 as the source of standardised terms. See our ISO institution profile |
* No company is named, because none could be confirmed from primary sources as having a relationship with the Commission.
6. Outlook
| What can be read | Primary source behind it | Type |
|---|---|---|
| The final content and timing of the REACH revision | The Commission's REACH page says the Commission is currently revising REACH. The status of the proposal could not be confirmed from official pages | Not yet confirmed |
| Whether the REACH "nanoform" definition will be changed to follow the 2022 Recommendation | Annex VI still rests on the 2011 Recommendation. A 2025 paper by JRC researchers and others argues that the "nanoform" definition should be revised in line with the updated Recommendation (not an official Commission position). No amendment of the law could be confirmed | Not yet confirmed |
| Adjustment of the Cosmetics Regulation definition of "nanomaterial" | Article 2(3) provides that the Commission shall adjust it to technical and scientific progress and to definitions agreed at international level. No later amendment could be confirmed | Not yet confirmed |
| The definitions in different laws may gradually converge on the 2022 Recommendation's wording | Recital 22 says a review should be considered when new evidence or regulatory experience arises, and recital 24 says that a horizontal act setting a definition would replace the Recommendation. The 2011 Recommendation has been incorporated into several pieces of EU legislation, including REACH (the Commission's page) | Inference |
7. Glossary
- Recommendation
- A type of EU legal act. Article 288 TFEU says recommendations have no binding force.
- Regulation
- A legal act that is binding in its entirety and directly applicable in all Member States.
- Nanoform
- A REACH term: a nanoscale form of a substance, whose characteristics must be described when registering.
- EUON
- The EU Observatory for Nanomaterials. Launched in 2017, funded by the Commission and run by ECHA as an information site.
- ECHA
- The European Chemicals Agency. The EU body at the centre of REACH, separate from the Commission.
- JRC
- The Commission's Joint Research Centre. It prepares guidance for implementing the definition.
8. References
- European Commission Role (the executive branch of the EU: proposing legislation, implementing decisions, upholding the treaties, day-to-day management). https://commission.europa.eu/about/role_en
- European Commission Organisation (27 Commissioners; over 33,000 staff; 56 departments and executive agencies). https://commission.europa.eu/about/organisation_en
- EU Treaty on European Union, consolidated (Article 17: the Commission's role, right of proposal, five-year term). https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12012M/TXT
- EU Treaty on the Functioning of the European Union, consolidated (Article 288: recommendations and opinions have no binding force; Article 289: ordinary legislative procedure). https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12012E/TXT
- European Commission Commission Recommendation of 10 June 2022 on the definition of nanomaterial (2022/C 229/01) (Official Journal C 229, 14 June 2022; recitals 3, 8, 15, 22, 23, 24; points 1 to 4). https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32022H0614(01)
- European Commission Commission Regulation (EU) 2018/1881 of 3 December 2018 amending REACH as regards Annexes I, III, VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances (Official Journal L 308, 4 December 2018; applies from 1 January 2020; the nanoform definition in Annex VI). https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32018R1881
- European Parliament and Council Regulation (EC) No 1223/2009 on cosmetic products (recast) (Official Journal L 342, 22 December 2009; Article 2(1)(k) and 2(3)). https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32009R1223
- European Commission REACH Regulation (Environment page: the role of ECHA; registration above one tonne per year; Regulations 2018/1881 and 2020/878; "currently revising" REACH). https://environment.ec.europa.eu/topics/chemicals/reach-regulation_en
- European Commission Nanomaterials (Internal Market page: incorporation of the 2011 Recommendation; the 2022 update; EUON launched 2017, funded by the Commission, hosted and maintained by ECHA). https://single-market-economy.ec.europa.eu/sectors/chemicals/reach/nanomaterials_en
- EUON (ECHA) Definition of nanomaterial (how REACH, the Biocidal Products Regulation and EFSA use the definition differently). https://euon.echa.europa.eu/definition-of-nanomaterial
- OECD NANOMET: Towards tailored safety testing methods for nanomaterials (an EU-funded three-year project, launched May 2020). https://www.oecd.org/en/topics/sub-issues/testing-of-chemicals/nanomet.html
- OECD Safe and sustainable by design tools, integrative systems and platforms for nanomaterials and nano-enabled products (December 2025; co-lead affiliations). https://www.oecd.org/content/dam/oecd/en/publications/reports/2025/12/safe-and-sustainable-by-design-tools-integrative-systems-and-platforms-for-nanomaterials-and-nano-enabled-products_6285c02d/e411a4b7-en.pdf
- ISO ISO/TC 229 Nanotechnologies (the European Commission and the OECD are listed among the liaison organisations). https://www.iso.org/committee/381983.html
- European Commission (JRC) Regulatory preparedness for multicomponent nanomaterials: current state, gaps and challenges of REACH (a 2025 paper by JRC researchers and others; not an official position). https://publications.jrc.ec.europa.eu/repository/handle/JRC139140
9. Claim-to-source audit
| Claim in the text | Type | Reference |
|---|---|---|
| The Commission is the EU's executive body, proposing legislation, implementing decisions and upholding the treaties; 27 Commissioners, over 33,000 staff, 56 organisations | Sourced | Reference 1 https://commission.europa.eu/about/role_en Reference 2 https://commission.europa.eu/about/organisation_en |
| The right to propose legislation (Article 17(2) TEU) and the five-year term | Sourced | Reference 3 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12012M/TXT |
| Recommendations and opinions have no binding force (Article 288); the ordinary legislative procedure is joint adoption by Parliament and Council (Article 289) | Sourced | Reference 4 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12012E/TXT |
| The content of Recommendation 2022/C 229/01: the definition, recitals 3, 8, 15, 22, 23 and 24, points 1 to 4, and that it updates the 2011 Recommendation | Sourced | Reference 5 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32022H0614(01) |
| Regulation 2018/1881: adoption date, Official Journal reference, application date, and the Annex VI nanoform definition based on the 2011 Recommendation | Sourced | Reference 6 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32018R1881 |
| The original definition of "nanomaterial" in the Cosmetics Regulation and the adjustment clause in Article 2(3) | Sourced | Reference 7 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32009R1223 |
| ECHA's role, registration above one tonne per year, Regulation 2020/878, and "currently revising" REACH | Sourced | Reference 8 https://environment.ec.europa.eu/topics/chemicals/reach-regulation_en |
| Incorporation of the 2011 Recommendation into several laws, the 2022 update, and EUON's launch, funding and hosting | Sourced | Reference 9 https://single-market-economy.ec.europa.eu/sectors/chemicals/reach/nanomaterials_en |
| Differences in how the Biocidal Products Regulation and EFSA use the definition | Sourced | Reference 10 https://euon.echa.europa.eu/definition-of-nanomaterial |
| NANOMET's EU funding, JRC researchers as OECD project co-leads, and the Commission's liaison with ISO/TC 229 | Sourced | Reference 11 https://www.oecd.org/en/topics/sub-issues/testing-of-chemicals/nanomet.html Reference 12 https://www.oecd.org/content/dam/oecd/en/publications/reports/2025/12/safe-and-sustainable-by-design-tools-integrative-systems-and-platforms-for-nanomaterials-and-nano-enabled-products_6285c02d/e411a4b7-en.pdf Reference 13 https://www.iso.org/committee/381983.html |
| JRC researchers and others stating in 2025 that the nanoform definition should be revised in line with the updated Recommendation (not an official position) | Sourced | Reference 14 https://publications.jrc.ec.europa.eu/repository/handle/JRC139140 |
| The four types of institution, the diagram in Fig. 2 and the description of EUON's position | Our calculation | Our own classification and diagram, based on references 4 to 6 and 9 |
| Staffing and budget for nanotechnology alone | Not yet confirmed | Not stated in references 1 and 2. This article does not estimate them |
| The content and timing of the REACH revision; whether the nanoform definition will be changed; adjustment of the Cosmetics Regulation definition | Not yet confirmed | Reference 8 https://environment.ec.europa.eu/topics/chemicals/reach-regulation_en Reference 6 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32018R1881 Reference 14 https://publications.jrc.ec.europa.eu/repository/handle/JRC139140 Reference 7 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32009R1223 |
| The one outlook point marked as inference in section 6 | Inference | This article's reading of recitals 22 and 24 in reference 5 and the incorporation described in reference 9 |
Last updated 9 October 2026 / Troy Technical
Figures and document status come from the European Commission's website as shown on 9 October 2026 and from the texts of the EU treaties and Official Journal. Items marked "Inference" are this article's reading of the primary sources.