Official Journal of the European Union

CE 184/82

Friday 24 April 2009


European Parliament resolution of 24 April 2009 on regulatory aspects of nanomaterials (2008/2208(INI))

2010/C 184 E/18

The European Parliament,

having regard to the Commission Communication of 17 June 2008 entitled ‘Regulatory aspects of nanomaterials’ (COM(2008)0366) and the accompanying Commission staff working document (SEC(2008)2036),

having regard to the Commission Communication of 12 May 2004 entitled ‘Towards a European strategy for nanotechnology’ (COM(2004)0338),

having regard to the Commission Communication of 7 June 2005 entitled ‘Nanosciences and nanotechnologies: An action plan for Europe 2005-2009’ (COM(2005)0243) (‘the action plan’) and to its resolution of 28 September 2006 (1) on the action plan,

having regard to the Commission Communication of 6 September 2007‘Nanosciences and nanotechnologies: An action plan for Europe 2005-2009. First Implementation Report 2005-2007’ (COM(2007)0505),

having regard to the opinions of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on definitions and risk assessment of nanomaterials (2),

having regard to the opinion of the Scientific Committee on Consumer Products (SCCP) on the safety of nanomaterials in cosmetics (3),

having regard to the Commission Recommendation on a code of conduct for responsible nanosciences and nanotechnologies research (COM(2008)0424) (‘Code of Conduct’),

having regard to the opinion from the European Group on Ethics in Science and New Technologies to the European Commission on the ethical aspects of nanomedicine (4),

having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (5),

having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (6),

having regard to Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (7) and its daughter directives,

having regard to Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (8) as well as specific product legislation, in particular Council Directive 76/768/EEC of 27 July 1976 on approximation of laws of the Member States relating to cosmetic products (9),

having regard to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (10), Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (11), Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (12), Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms (13), and Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (14),

having regard to 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, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (15),

having regard to Community environmental legislation, in particular Directive 2008/1/EC of the European Parliament and of the Council of 15 January 2008 concerning integrated pollution prevention and control (16), Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (17) and Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste (18),

having regard to Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising (19),

having regard to Rule 45 of its Rules of Procedure,

having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Employment and Social Affairs (A6-0255/2009),


whereas the use of nanomaterials and nanotechnologies (hereinafter referred to as ‘nanomaterials’) promises important advances with multiple benefits in innumerable applications for consumers, patients and the environment, as nanomaterials can provide different or new properties compared to the same substance or material in normal form,


whereas the advances in nanomaterials are expected to have significant influence on policy decisions in the fields of public health, employment, occupational safety and health, information society, energy, transport, security and space,


whereas despite the introduction of a specific European strategy on nanotechnologies and the subsequent allocation of approximately EUR 3 500 000 000 for research in nanosciences for the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) (FP7), the European Union is lagging behind its current main competitors – the USA, Japan and South Korea – who account for over half of the investment and two-thirds of the patents filed worldwide,


whereas nanomaterials on the other hand potentially present significant new risks due to their minute size, such as increased reactivity and mobility, possibly leading to increased toxicity in combination with unrestricted access to the human body, and possibly involving quite different mechanisms of interference with the physiology of human and environmental species,


whereas the safe development of nanomaterials can make an important contribution to the competitiveness of the European Union’s economy and to the achievement of the Lisbon strategy,


whereas the current discussion about nanomaterials is characterised by a significant lack of knowledge and information, leading to disagreement starting at the level of definitions:


concerning the size: approximate indication of the size (‘in the order of 100 nm or less’) versus a specific size range (‘between 1 and 100 nm’),


concerning different/new properties: different/new properties due to size effects, including particle number, surface structure and surface activity, as an independent criterion versus using such properties as an additional criterion for the definition of nanomaterials,


concerning problematic properties: limitation of the definition of nanomaterials to certain properties (e.g. insoluble or persistent), or not making such limitations,


whereas a fully developed set of harmonised definitions is not currently available although a number of international standards are either available or in progress, defining ‘nanoscale’ as ‘having one or more dimensions of the order of 100 nm or less’, and often distinguishing between:

nano-objects, defined as ‘discrete pieces of materials with one, two or three external dimensions at the nanoscale’, i.e. as materials constituted by isolated objects with very small dimensions,

nano-structured materials, defined as materials ‘having an internal or surface structure at the nanoscale’, e.g. exhibiting cavities of small dimensions,


whereas there is no clear information about the actual use of nanomaterials in consumer products, for instance:

while inventories by renowned institutions list more than 800 manufacturer-identified nanotechnology-based consumer products currently on the market, trade associations of the same manufacturers question these figures, on the basis that they are overestimations, without providing any concrete figures themselves,

while companies happily use ‘nano-claims’, as the term ‘nano’ seems to have a positive marketing effect, they are strictly opposed to objective labelling requirements,


whereas clear notification requirements on the use of nanomaterials, information to consumers as well as full enforcement of Directive 2006/114/EC are necessary to provide reliable information on the use of nanomaterials,


whereas presentations about the potential benefits of nanotechnologies predict an almost infinite diversity of future applications of nanomaterials, but fail to provide reliable information about current uses,


whereas there is a major debate about the possibility of assessing the safety of nanomaterials; whereas the scientific committees and Agencies of the European Union point to major deficiencies not only in key data, but even in methods of obtaining such data; whereas the European Union thus needs to invest more into adequate assessment of nanomaterials to close the knowledge gaps and to develop and implement as fast as possible, and, in collaboration with its agencies and international partners, methods of evaluation and an appropriate and harmonised metrology and nomenclature,


whereas SCENIHR identified some specific health hazards as well as toxic effects on environmental organisms for some nanomaterials; whereas SCENIHR furthermore found a general lack of high-quality exposure data both for humans and the environment, concluding that the knowledge on the methodology for both exposure estimates and hazard identification needs to be further developed, validated and standardised,


whereas current funding for research into the environmental, health and safety aspects of nanomaterials in FP7 is far too low; whereas moreover the evaluation criteria for granting research projects to assess the safety of nanomaterials under FP7 are too restrictive (i.e. they have a narrow innovation bias), and thus do not sufficiently promote the urgent development of scientific methods to assess nanomaterials; whereas it is essential to allocate sufficient resources for research on the safe development and use of nanomaterials,


whereas knowledge about potential health and environmental impacts of nanomaterials lags significantly behind the pace of market developments in light of the very rapid developments in the field of nanomaterials, thus raising fundamental questions about the ability of the current regulations to deal with emerging technologies such as nanomaterials in ‘real time’,


whereas, in its resolution of 28 September 2006 on nanosciences and nanotechnologies Parliament had called for investigation of the effects of nanoparticles that are not readily soluble or biodegradable, in accordance with the precautionary principle, before such particles are put into production and placed on the market,


whereas the value of the above-mentioned Commission Communication entitled ‘Regulatory aspects of nanomaterials’ is rather limited due to the absence of information about the specific properties of nanomaterials, their actual uses, and potential risks and benefits, and thus no consideration of the legislative and policy challenges that result from the specific nature of nanomaterials, resulting in only a general legal overview that shows that there are no nano-specific provisions in Community legislation for the time being,


whereas nanomaterials should be covered by a multi-faceted, differentiated and adaptive body of law based on the precautionary principle (20), the principle of producer responsibility and the polluter-pays principle to ensure the safe production, use and disposal of nanomaterials before the technology is put on the market, while avoiding systematic recourse to general moratoria or undifferentiated treatment of different applications of nanomaterials,


whereas the almost infinite application of nanotechnologies to such diverse sectors as electronics, textiles, biomedicals, personal care products, cleaning products, food or energy makes it impossible to introduce a single regulatory framework at Community level,


whereas, in the context of REACH, it has already been agreed that further guidance and advice on nanomaterials, in particular on substance identification, as well as an adaptation of risk assessment methods is needed; whereas a closer look at REACH reveals several further deficiencies to deal with nanomaterials,


whereas waste legislation in the absence of nano-specific provisions may not apply correctly,


whereas nanomaterials, throughout their whole life cycle, raise major challenges for occupational health and safety, as many workers along the production chain are exposed to those materials without knowing whether the safety procedures implemented and the protection measures taken are adequate and efficient; notes that the number and diversity of workers exposed to the effects of nanomaterials are expected to increase in the future,


whereas the significant amendments concerning nanomaterials adopted in a first reading agreement between the Council and the European Parliament in the context of the recast of the cosmetics directive (21), and the significant amendments adopted by the European Parliament in the first reading of the review of the regulation on novel food (22), respectively, highlight the need to amend relevant Community legislation to address nanomaterials adequately,


whereas the current debate about regulatory aspects of nanomaterials is largely limited to expert circles, even though nanomaterials have the potential to bring about far-ranging societal change, which requires wide-ranging public consultation,


whereas a broad application of patents to nanomaterials, as well as the excessive cost of patenting and the absence of patent access facilities for very small businesses and small and medium-sized enterprises (SMEs), could stifle further innovation,


whereas the likely convergence of nanotechnology with biotechnology, biology, cognitive sciences and information technology raises serious questions relating to ethics, safety, security and respect for fundamental rights that need to be analysed by a new opinion of the European Group on Ethics in Science and New Technologies,


whereas the Code of Conduct is an essential instrument for safe, integrated and responsible research in nanomaterials; whereas the Code of Conduct must be adopted and respected by all producers intending to manufacture or place goods on the market,


whereas the review of all relevant Community legislation should implement the principle ‘no data, no market’ for nanomaterials,


Is convinced that the use of nanomaterials should respond to the real needs of citizens and that their benefits should be realised in a safe and responsible manner within a clear regulatory and policy framework (legislative and other provisions) that explicitly addresses existing and expected applications of nanomaterials as well as the very nature of potential health, environmental and safety problems;


Deplores the absence of a proper evaluation of the de facto application of the general provisions of Community law in the light of the actual nature of nanomaterials;


Does not agree, before an appropriate evaluation of current Community legislation, and in the absence of any nano-specific provisions therein, with the Commission’s conclusions that a) current legislation covers in principle the relevant risks relating to nanomaterials, and b) that the protection of health, safety and the environment needs mostly be enhanced by improving implementation of current legislation, when due to the lack of appropriate data and methods to assess the risks relating to nanomaterials it is effectively unable to address their risks;


Considers that the concept of the ‘safe, responsible and integrated approach’ to nanotechnologies advocated by the European Union is jeopardised by the lack of information on the use and on the safety of nanomaterials that are already on the market, particularly in sensitive applications with direct exposure of consumers;


Calls on the Commission to review all relevant legislation within two years to ensure safety for all applications of nanomaterials in products with potential health, environmental or safety impacts over their life cycle, and to ensure that legislative provisions and instruments of implementation reflect the particular features of nanomaterials to which workers, consumers and/or the environment may be exposed;


Stresses that such review is not only necessary to adequately protect human health and the environment, but also to provide certainty and predictability to economic operators as well as public confidence;


Calls for the introduction of a comprehensive science-based definition of nanomaterials in Community legislation as part of nano-specific amendments to relevant horizontal and sectoral legislation;


Calls on the Commission to promote the adoption of a harmonised definition of nanomaterials at the international level and to adapt the relevant European legislative framework accordingly;


Considers it particularly important to address nanomaterials explicitly within the scope of at least legislation on chemicals (REACH, biocides), food (foodstuffs, food additives, food and feed products from genetically modified organisms), relevant legislation on worker protection, as well as legislation on air quality, water quality and waste;


Calls for the application of a duty of care for manufacturers that wish to place nanomaterials onto the market; and calls on them to adhere to the European code of conduct for responsible nanosciences and nanotechnologies research;


Calls specifically on the Commission to evaluate the need to review REACH concerning inter alia:

simplified registration for nanomaterials manufactured or imported below one tonne,

consideration of all nanomaterials as new substances,

a chemical safety report with exposure assessment for all registered nanomaterials,

notification requirements for all nanomaterials placed on the market on their own, in preparations or in articles;


Calls specifically on the Commission to evaluate the need to review waste legislation concerning inter alia:

a separate entry for nanomaterials in the list of waste established by Decision 2000/532/EC (23),

a revision of the waste acceptance criteria in landfills in Decision 2003/33/EC (24),

a revision of relevant emission limit values for waste incineration to supplement the mass-based measurements by metrics based on particle number and/or surface;


Calls specifically on the Commission to evaluate the need to review emission limit values and environmental quality standards in air and water legislation to supplement the mass-based measurements by metrics based on particle number and/or surface to adequately address nanomaterials;


Underlines the importance for the Commission and/or Member States to ensure full compliance with, and enforcement of, the principles of Community legislation on the health and safety of workers when dealing with nanomaterials, including adequate training for health and safety specialists, to prevent potentially harmful exposure to nanomaterials;


Calls specifically on the Commission to evaluate the need to review worker protection legislation concerning inter alia:

the use of nanomaterials only in closed systems or in other ways that exclude exposure of workers as long as it is not possible to reliably detect and control exposure,

a clear assignment of liability to producers and employers arising from the use of nanomaterials,

whether all exposure routes (inhalation, dermal and other) are addressed;


Calls on the Commission to compile before June 2011 an inventory of the different types and uses of nanomaterials on the European market, while respecting justified commercial secrets such as recipes, and to make this inventory publicly available; furthermore calls on the Commission to report on the safety of these nanomaterials at the same time;


Reiterates its call for the provision of information to consumers on the use of nanomaterials in consumer products: all ingredients present in the form of nanomaterials in substances, mixtures or articles should be clearly indicated in the labelling of the product (e.g. in the list of ingredients, the name of such ingredients should be followed by the word ‘nano’ in brackets);


Calls for full enforcement of Directive 2006/114/EC to ensure that that there is no misleading advertising with nanomaterials;


Calls for the urgent development of adequate testing protocols and metrology standards to assess the hazard of, and exposure of workers, consumers and the environment to, nanomaterials over their entire life cycle, including in the case of accidents, using a multi-disciplinary approach;


Calls for a major stepping up of the funding of research into the environmental, health and safety aspects of nanomaterials over their life cycle, e.g. via the establishment of a special European Fund within FP7; furthermore calls specifically on the Commission to revise the evaluation criteria under FP7 so that FP7 attracts and funds significantly more research to improve the scientific methodology to assess nanomaterials;


Calls on the Commission to promote coordination and exchange between Member States on research and development, risk assessment, guidance development and regulation of nanomaterials by using existing mechanisms (e.g. REACH Competent Authorities Subgroup on Nanomaterials) or by creating additional ones, if appropriate;


Calls on the Commission and Member States to propose, as soon as possible, the establishment of a permanent and independent European network responsible for monitoring nanotechnologies and nanomaterials, and a basic and applied research programme on the methodology for this monitoring (particularly metrology, detection, toxicity and epidemiology);


Asks the Commission and the Member States to launch an EU-wide public debate on nanotechnologies and nanomaterials and on the regulatory aspects of nanomaterials;


Recognises that it is essential to remove the obstacles preventing very small businesses and SMEs in particular from accessing patents and calls at the same time for patent rights to be limited to specific applications or production methods of nanomaterials, and only to be extended to nanomaterials themselves on an exceptional basis, to avoid stifling innovation;


Considers that stringent ethical guidelines need to be developed in due time, particularly for nanomedicine, such guidelines being the right to privacy, free and informed consent, the limits set on non-therapeutic human enhancement, whilst offering encouragement to this promising interdisciplinary domain with breakthrough technologies such as molecular imaging and diagnostics, which can offer impressive benefits for the early diagnosis and smart and cost-effective treatment of many diseases; asks the European Group on Ethics in Science and New Technologies to draw up an opinion on this issue, building on its Opinion No 21 of 17 January 2007 on ‘Ethical aspects of nanomedicine’ and drawing on the ethical opinion issued by EU national ethics bodies as well as the work undertaken by international organisations such as UNESCO;


Calls on the Commission and Member States to pay special attention to the social dimension of the development of nanotechnology; furthermore considers that the active participation of the social partners concerned has to be ensured from the earliest possible stage;


Calls on the Commission to evaluate the need to review legislation to address nanomaterials that are created as unintended by-products of combustion processes in a cost-effective manner;


Instructs its President to forward this resolution to the Council and the Commission, and to the governments and parliaments of the Member States.

(1)  OJ C 306 E, 15.12.2006, p. 426.

(2)  Opinion on ‘The scientific aspects of the existing and proposed definitions relating to products of nanoscience and nanotechnologies; 29 November 2007’; http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_012.pdf And accompanying Information by Commission services concerning the SCENIHR Opinion on Scientific Aspects of Existing and Proposed Definitions relating to Products of Nanoscience and Nanotechnologies; http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_oc_012.pdf Opinion on The Appropriateness of the Risk Assessment methodology in accordance with the technical guidance documents for new and existing substances for assessing the risks of nanomaterials; 21-22 June 2007; http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_010.pdf Modified opinion (after public consultation) on The appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies; 10 March 2006; http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_003b.pdf Opinion on Risk Assessment of Products of Nanotechnologies; 19 January 2009; http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf

(3)  Opinion on Safety of nanomaterials in cosmetic products; 18 December 2007; http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_123.pdf

(4)  Opinion No 21, 17 January 2007.

(5)  OJ L 396, 30.12.2006, p. 1.

(6)  OJ L 123, 24.4.1998, p. 1.

(7)  OJ L 183, 29.6.1989, p. 1.

(8)  OJ L 11, 15.1.2002, p. 4.

(9)  OJ L 262, 27.9.1976, p. 169.

(10)  OJ L 31, 1.2.2002, p. 1.

(11)  OJ L 354, 31.12.2008, p. 16.

(12)  OJ L 109, 6.5.2000, p. 29.

(13)  OJ L 268, 18.10.2003, p. 24.

(14)  OJ L 43, 14.2.1997, p. 1.

(15)  OJ L 353, 31.12.2008, p. 1.

(16)  OJ L 24, 29.1.2008, p. 8.

(17)  OJ L 327, 22.12.2000, p. 1.

(18)  OJ L 114, 27.4.2006, p. 9.

(19)  OJ L 376, 27.12.2006, p. 21.

(20)  Commission Communication of 2 February 2000 on the precautionary principle (COM(2000)0001).

(21)  Position of the European Parliament of 24 March 2009, Texts adopted, P6_TA(2009)0158.

(22)  Position of the European Parliament of 25 March 2009, Texts adopted, P6_TA(2009)0171.

(23)  Commission Decision 2000/532/EC of 3 May 2000 replacing Decision 94/3/EC establishing a list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on waste and Council Decision 94/904/EC establishing a list of hazardous waste pursuant to Article 1(4) of Council Directive 91/689/EEC on hazardous waste (OJ L 226, 6.9.2000, p. 3).

(24)  Council Decision 2003/33/EC of 19 December 2002 establishing criteria and procedures for the acceptance of waste at landfills pursuant to Article 16 of and Annex II to Directive 1999/31/EC (OJ L 11, 16.1.2003, p. 27).