Annexes to COM(2012)572 - Second Regulatory Review on Nanomaterials - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2012)572 - Second Regulatory Review on Nanomaterials . |
|---|---|
| document | COM(2012)572  |
| date | October 3, 2012 |
The Commission Recommendation on a definition of nanomaterial will clarify terminology, but will in itself not provide the necessary clarity to the registrants on how to address nanomaterials in REACH registrations.
The Commission will therefore, based on available information on technical progress, including the REACH Implementation Projects on Nanomaterials and experience with the current registrations, in the upcoming REACH review assess relevant regulatory options, in particular possible amendments of REACH annexes, to ensure clarity on how nanomaterials are addressed and safety demonstrated in registrations.
5.2. Substance identification and registration timelines
Many substances exist as bulk and nanoforms. The nanoforms can be seen as forms of the same substance or as distinct substances. In the latter case, the question arises whether they are treated as “new” substances and whether they would be subject to immediate registration.[22]
When more experience from the evaluation of registrations is available, ECHA will provide guidance on treating nanomaterials as forms of a bulk substance or as distinct substances with the aim of enabling effective data sharing. The results of the REACH Implementation Project on Nanomaterials on Substance Identification (RIPoN1) suggest, however, that some flexibility will be needed. Whether nanoforms have been addressed in one or several registrations, for the Commission the key issue remains whether the registration provides clear information on the safe use for all forms of the substance.
5.3. Chemical safety assessment
RIPoN on Information Requirements (RIPoN2) and the RIPoN on Chemical Safety Assessment (RIPoN3)[23] address – inter alia - the question whether the existing REACH requirements and the relevant guidance are appropriate to assess nanomaterials. They contain a number of specific proposals.
RIPoN 2 concluded that, with a few caveats, the guidance at the time of the project and the information requirements were considered applicable for the assessment of nanomaterials. RIPoN3 concluded that known exposure assessment methods were generally applicable but may still experience methodological challenges.
The REACH approach to hazard assessment and risk characterisation, with its built-in flexibility, makes it overall suitable for nanomaterials. The key remaining question is to what extent data for one form of a substance can be used to demonstrate the safety of another form, due to still developing understanding of e.g. drivers of toxicity. In a case-by-case scientific approach:
· Clarity is required whether and which nanoforms of a substance are covered by a registration. These nanoforms should be adequately characterised, and the user should be able to identify which operational conditions and risk management measures apply to them.
· Information should be provided on which forms of a substance have been tested, with the test conditions adequately documented.
· Conclusions of a chemical safety assessment should cover all forms in a registration. Where data from one form of a substance are used in demonstration of the safe use of other forms, a scientific justification should be given on how, applying the rules for grouping and read-across[24], the data from a specific test or other information can be used for the other forms of the substance. Similar considerations apply to exposure scenarios and the risk management measures.
ECHA has updated guidance to take into account the final RIPoN Reports. ECHA has set up a Group Assessing Already Registered Nanomaterials (GAARN), who considers in co-operation with the Commission, Member States experts and stakeholders, a few key nanomaterial registrations. The purpose is to identify best practices for assessment and reporting of nanomaterials in REACH registrations and to develop recommendations on how to fill potential information gaps. In addition, ECHA has set up a Nanomaterials Working Group to give advice on scientific and technical issues in relation to nanomaterials under REACH.
5.4. Extension of REACH obligations to small volume nanomaterials
Most nanomaterials which are subject to a scientific debate are manufactured or imported in volumes of 1 tonne per year or more. Small volume nanomaterials are mostly used in technical applications such as catalysts or in applications where the nanomaterials are bound in a matrix or enclosed in equipment. Consumer and environmental exposure to those nanomaterials is likely to be limited.
In line with SCENIHR’s conclusion that nanomaterials are similar to normal substances in that some may be toxic and some may not, the Commission does not consider appropriate at present to change the rules for when a chemicals safety assessment is required. As regards registration thresholds and timelines for registration based on volume, the Commission considers REACH appropriate, subject to actions outlined in chapter 7.
6. Health, Safety and Environment protection in EU legislation
The Parliament called on the Commission to evaluate the need to review a number of areas of legislation, including air, water, waste, industrial emissions and worker protection legislation.
· As regards safety and health at work, the ongoing work can be summarized as follows:
In addition to the study on nanomaterials in the workplace[25], a Nano subgroup of the Chemicals working party set up under the Advisory Committee on Safety and Health at Work is working on a draft opinion on risk assessment and management of nanomaterials at the workplace, to be subsequently endorsed by the Advisory Committee. A final assessment on a review of occupational health and safety legislation will be made by 2014 in the light of these activities and respective conclusions.
· As regards consumer product safety legislation, work is under way on adapting the relevant legislation in order to transpose the horizontal definition and to introduce specific provisions on nanomaterials; on updating the relevant risk assessment processes; on strengthening market surveillance; and on improving information and labelling requirements:
The Commission is committed to implement the definition of nanomaterials in consumer product safety legislation, when appropriate. Specific provisions on nanomaterials have been introduced for biocides, cosmetics, food additives, food labelling and materials in contact with foodstuff.
At the same time, the Commission undertook a detailed analysis of how consumer product legislation is being implemented with reference to nanomaterials. The main challenge remains the implementation of a proper risk assessment, also in those areas where legislative change has been implemented.
Therefore, for instance, EFSA has at the request of the Commission adopted a guidance document[26] clarifying the data to be provided when submitting an application dossier for a nanomaterial to be incorporated in food and feed.
Similarly, guidance has recently been developed by the Scientific Committee on Consumer Safety for cosmetic products.
The Commission takes the view that current legislation on medicinal products allows an appropriate risk/benefit analysis and risk management of nanomaterials.
For legislation on medical devices, actions under consideration include a labelling requirement in a proposal foreseen for 2012. In addition, the Commission is considering to reclassify devices containing free nanomaterials under Class III, making them subject to the most severe conformity assessment procedure(s).
The Commission considers that New Approach and in general consumer product legislation allow nano-specific issues to be taken into consideration.
Market surveillance is a key element in effective consumer protection, and the Commission is facilitating a joint surveillance pilot project with various Member States on the presence of nanomaterials in cosmetic products.
A main issue in the debate on nanomaterials is consumer information and labelling of nanomaterials. Nano-ingredient labelling has been introduced in products of relevance to consumers, notably food and cosmetics.
Similar provisions can be envisaged for other regulatory schemes where ingredient labelling already exists, allowing consumers to make an informed choice.
· As regards environmental legislation, the evaluation[27] of this legislation identified and assessed environmental exposure pathways for nanomaterials relevant to each piece of legislation, the level of control afforded over possible releases of nanomaterials and the associated risks.
The evaluation showed that all environmental legislation reviewed could be considered to address nanomaterials in principle. Nevertheless, this might pose challenges and has not been tested in practice. Principal triggers of pollutant identification are hazard classification under CLP and exposure information. There is still a considerable lack of data on exposure to nanomaterials via the environment. Consequently, no specific provisions for nanomaterials have yet been established in EU environmental legislation, triggering measures to control such pollutants through monitoring, separate treatment or environmental quality standards. This applies also to the risk management responses explicitly identified by the European Parliament: new environmental quality standards, revision of emission limit values, a separate entry for nanomaterials in the list of waste and the revision of waste acceptance criteria in landfills. As risk characterisation may depend on particle size or surface functionalization, it is anticipated that setting the precise scope, dose metrics and value of any thresholds employed under environmental legislation, if necessary, would be more challenging than for conventional pollutants. REACH should generate relevant data in this respect.
Even when it is possible to show the presence of specific nanoparticles in environmental media or waste, it would be technically difficult to separate or eliminate them. Therefore 'end-of-pipe' measures would not be effective to prevent potential negative impacts on the environment or health, nor would they allow addressing any emerging recycling challenges or need for remediation in a cost-effective manner.
Although the Commission does not exclude specific provisions in downstream environmental legislation, potential risks are normally best addressed "upstream" by REACH and product legislation. Any CLP classification of a nanomaterial will automatically unlock some operative provisions across a range of environmental legislation that serve to control releases of hazardous substances into the environment.
The Commission is also taking steps to ensure that remaining implementation gaps of the legislation are addressed. For example, revisions of the selection process for priority substances under the water legislation and the relevant BREF[28] documents under industrial emissions legislation, incorporating various nanomaterial aspects, are already being pursued.
Developing capacity to monitor and model nanomaterials, e.g. in the environment is necessary. This will facilitate the evaluation of the efficiency of different tools of the environmental legislation and inform appropriate risk management strategies. Where necessary, this will be supported by targeted implementing environmental legislation.
7. Need for better accessible information
Transparency of information on nanomaterials and products containing nanomaterials is essential. This has been recognised by the Parliament which has called on the Commission to evaluate the need for notification requirements for all nanomaterials, including in mixtures and articles, and the Council, which invited the Commission to evaluate the need for the further development of a harmonized database for nanomaterials, while considering potential impacts.
Current knowledge about nanomaterials does not suggest risks which would require information about all products in which nanomaterials are used. Experience so far shows that, if risks were to be identified, they could be handled with the existing tools such as the General Product Safety Directive[29] and its RAPEX system[30], or more specific instruments under EU product legislation.
Currently available information (such as the information presented in the attached Staff Working Paper and the information generated by existing legislative tools such as REACH and the Cosmetics Regulation) is considered a good basis for policy making.
As a first step, the Commission will create a web platform with references to all relevant information sources, including registries on a national or sector level, where they exist. A first version mainly based on links to available information will be put on line as soon as possible. The Commission will assist in the elaboration of harmonised data formats, to improve exchange of information. In parallel, the Commission will be launching an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight, including an in-depth analysis of the data gathering needs for such purpose. This analysis will include those nanomaterials currently falling outside existing notification, registration or authorisation schemes.
8. Conclusions
In the light of current knowledge and opinions of the EU Scientific and Advisory Committees and independent risk assessors, nanomaterials are similar to normal chemicals/substances in that some may be toxic and some may not. Possible risks are related to specific nanomaterials and specific uses. Therefore, nanomaterials require a risk assessment, which should be performed on a case-by-case basis, using pertinent information. Current risk assessment methods are applicable, even if work on particular aspects of risk assessment is still required.
The definition of nanomaterials will be integrated in EU legislation, where appropriate. The Commission is currently working on detection, measurement and monitoring methods for nanomaterials and their validation to ensure the proper implementation of the definition.
Important challenges relate primarily to establishing validated methods and instrumentation for detection, characterization, and analysis, completing information on hazards of nanomaterials and developing methods to assess exposure to nanomaterials.
Overall the Commission remains convinced that REACH sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures but more specific requirements for nanomaterials within the framework have proven necessary. The Commission envisages modifications in some of the REACH Annexes and encourages ECHA to further develop guidance for registrations after 2013.
The Commission will carefully follow developments, and report back to the Parliament, the Council and the European Economic and Social Committee within 3 years.
ANNEX
Action || Content || Timeline
Nanomaterial Definition || Implementation of definition into European Union legislation and use in Union Agencies || Done for biocides; adaptation of the definition for cosmetics is in progress
Report on existing measurement methods, possible update of Q&A || 2012
Proposal for a first set of detection, measurement and monitoring methods || 2014
Review of definition || 2014
REACH and CLP || Possible amendment of REACH Annexes || Planning and Timelines will be addressed in REACH Review
CASG(Nano) – Subgroup of REACH and CLP Competent Authorities (CARACAL), advising the Commission on regulatory issues relating to REACH and CLP || Set up in 2008
Evaluation of REACH registration dossiers concerning nanomaterials || Nanomaterials prioritised by ECHA for compliance check; substance evaluation according to the “CoRAP” list (currently including silicon dioxide (NL 2012), silver (NL 2013) and titanium dioxide (F 2014))
ECHA assessment of nanomaterials in REACH registration and CLP notification dossiers || Done (see Appendix 3 of Staff Working Paper)
Nano Support Project (JRC in cooperation with ECHA) || Part 1 (identification of registration dossiers covering nanomaterials, scientific assessment and proposals to address shortcomings) – done and available on http://ec.europa.eu/environment/chemicals/nanotech/pdf/jrc_report.pdf, part 2 (assessment of potential economic and environmental consequences of the technical proposals made in Task I) expected in October 2013
GAARN (Group on Assessing Already Registered Nanomaterials) – Informal group to assess three selected registration dossiers on nanomaterials || Set up in 2012, end of work foreseen in 2013
ECHA Nanomaterial Working Group – Permanent Group to advise ECHA on scientific and technical aspects relating to nanomaterials || Set up in 2012
ECHA Guidance Update for Registration || Done, further updates possible after the end of the next registration round
Update of IUCLID to facilitate submission of structured information on NM || Initial solutions provided already in 2010 (IUCLID 5.2) and recently in 2012 (IUCLID 5.4); further relevant updates expected after the REACH 2013 deadline
Cosmetics || Assessment of individual substances || ETH-50: concluded; titanium dioxide, zinc oxide, HAA299: foreseen for 2012
Joint market surveillance pilot project on nanomaterials in cosmetics || 2013
Medicines || Authorisation of individual medicines || 20 medicines authorised so far, further assessments as the case arises
Food || Mandatory labelling for nano-ingredients in food introduced in labelling Regulation || Labelling applicable from December 2014
Definition of "engineered nanomaterial" in labelling Regulation || Definition to be updated to Commission Recommendation
Pre-market approval under Novel Food Regulation for food under nano form || To be addressed in the Novel Food Proposal foreseen for 2013
Requirement for risk assessment for food additives and food contact materials || For additives and food contact materials risk assessment as the case arises (with authorisation where appropriate)
Food contact materials || Authorisation of individual food contact materials || Two nanomaterials authorised; further assessments as the case arises
Worker Protection Legislation || Study on occupational risks of nanomaterials || 2013
Final assessment on review of occupational health and safety legislation || 2014
OECD Working Party on Manufactured Nanomaterials || Eight subgroups, including one on safety testing of a set of representative manufactured nanomaterials which should provide data on 13 selected nanomaterials || Current Programme started in 2009, with work towards completion of Phase1 well progressed
Mandate M/461 to CEN || Development of methods for nanomaterial characterisation, sampling, measurement and exposure simulation || Work started in 2010, will take several more years
Research, Development and Innovation activities under Horizon 2020 || The proposal for the Regulation establishing Horizon2020 (COM(2011)809) identifies Nanotechnologies as one of the six Key Enabling Technologies (KETs) under the Industrial Leadership pillar. Ensuring the safe development and application of nanotechnologies is one of the main lines of activity. || Final calls under 7th Framework Programme for Research to bridge gap towards Horizon 2020
Nano-ingredient labelling || || Implemented in the Cosmetics and Biocides Regulations
Information on Nanomaterials || Information on Nanomaterial Types and Uses, including Safety Aspects (overview of available information as well as information sources, databases, etc.) || Done (Annexed Staff Working Document)
Web-platform || 2013
Study on nanomaterials falling outside the scope of existing notification or registration requirements and options for getting information || 2013
[1] COM (2008) 366, 17.6.2008
[2] Resolution European Parliament on Regulatory Aspects of Nanomaterials (2008/2208(INI), 24.4.2009
[3] Conclusions on “improving environmental policy instruments” of 20 December 2010
[4] Opinion European Economic and Social Committee; INT/456 of 25.2.2009, Nanomaterials
[5] SWD(2012) 288 final
[6] Commission Recommendation 2011/696/EU, OJ L 275, 20.10.2011
[7] SWP, p. 10.
[8] Carbon black accounts for around 85% of total nanomaterials on the market in terms of tonnage, synthetic amorphous silica accounts for another 12%.
[9] http://www.forfas.ie/media/forfas310810-nanotech_commercialisation_framework_2010-2014.pdf, referring to Lux Research. Those figures refer to the value of products into which nanomaterials are incorporated (as opposed to the value of nanomaterials marketed).
[10] http://ec.europa.eu/enterprise/sectors/ict/files/kets/hlg_report_final_en.pdf, p. 13.
[11] http://ec.europa.eu/enterprise/sectors/ict/key_technologies/kets_high_level_group_en.htm
[12] http://ec.europa.eu/enterprise/sectors/ict/files/kets/act_en.pdf
[13] http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf, p. 52 and p. 56.
[14] Scientific opinion on "Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain” (2011), 9(5):2140.
[15] http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000345.jsp&mid=WC0b01ac05800baed9
[16] Namely silicon dioxide, carbon black and titanium nitride. Silicon dioxide has also been authorised as food additive.
[17] M/461 EN of 2.2.2010
[18] Regulation (EC) No 1907/2006 of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). OJ L 136, 29.5.2007, p.3. Unofficial consolidated version see:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2006R1907:20110505:en:PDF
[19] For an explanation of terminology see http://ec.europa.eu/enterprise/sectors/chemicals/files/reach/nanomaterials_en.pdf
[20] Regulation (EC) No 1272/2008 of 16 December 2008 on classification, labelling and packaging of substances and mixtures, OJ L353, 31.12.2008
[21] For details see SWP, chapter 5.2 and appendix 3.
[22] Any immediate registration requirement for nanomaterials treated as new substance could reasonably only apply from the moment that the interpretation of the REACH provisions was clear enough for registrants to exclude the interpretation that the nanomaterial is a form of an existing substance.
[23] http://ec.europa.eu/environment/chemicals/nanotech/index.htm#ripon
[24] REACH, Annex XI, section 1.5
[25] See section 4.2
[26] Scientific opinion on "Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain (2011)”, 9(5):2140.
[27] http://ec.europa.eu/environment/chemicals/nanotech
[28] BREFs - Best available technique REFerence Documents define Best Available Technique (BAT) for individual industrial sectors under the Industrial Emission Directive
[29] Directive 2001/95/EC OJ L 11, 15.1.2002.
[30] http://ec.europa.eu/consumers/safety/rapex/index_en.htm