/ EUROPEAN COMMISSION
ENVIRONMENT DIRECTORATE-GENERAL
Green Economy
Chemicals
ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL
Resources Based, Manufacturing and Consumer Goods Industries
REACH
Chemicals Industry

Brussels, 12 November 2013

Doc. CA/14/2013rev.1

13th Meeting of Competent Authorities
for REACH and CLP

26 – 28November 2013

Concerns: Additional measures to increase transparency and ensure regulatory oversight on nanomaterials

Agenda Point:4.3

Action Requested:For information

1.Background

As part of the Communication on the Second Regulatory Review on Nanomaterials (COM(2012) 572 final), the Commission has announced to launch “an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight [on nanomaterials], 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.”

This project is complementary to the separate initiative on the adapting REACH annexes for nanomaterials which is intended to bring a necessary clarity on the information within registration dossiers covering nanomaterial forms of substances.

The subject of this impact assessment will be whether in addition to existing information requirements, and those considered for the planned revision of REACH annexes, there should be new measures to increase transparency and ensure regulatory oversight on nanomaterials (in the following called "transparency measure(s)"). The impact assessment shall cover nanomaterials as defined in Recommendation 2011/696/EU[1] (for possible restrictions as regards the scope of possible measures see below). Possible measures includenon-regulatory options and regulatory measures such as European Union wide requirements for companies to register or notify nanomaterials in substances, mixtures or articles they manufacture, import or use. Existing requirements to register nanomaterials include REACH, CLP and the Cosmetics Regulation as well as compulsory national schemes (so far only in France). Existing information is not least the Staff Working Paper on Nanomaterial Types and Uses, including Safety Aspects (SWD(2012) 288 final). The Commission has also announced a webplatform to link to available information.

The European Parliament called on the Commission to compile 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. Austria, Belgium, the Czech Republic, Denmark, France, Italy, Luxemburg, the Netherlands, Spain, Sweden and Croatia have asked the Commission to “propose legislation on registration or market surveillance of nanomaterials or products containing nanomaterials”. France has already put in place relevant national legislation, requiring producers, importers and distributors of nanomaterials on their own, in mixtures where they are not bound and in materials from which they are intended to be released to submit an annual declaration on the quantities, uses and clients to whom these nanomaterials have been sold. The declaration must be submitted for all nanomaterials produced or placed on the market in quantities exceeding 100 grams. The objective is to create full information and traceability of nanomaterials throughout the supply chain. Belgium and Denmark have announced their intentions to introduce similar legislation. Germany has recently sent implementation proposals for a nanomaterial registry. A “nanomaterial registry” has also been called for by a number of non-governmental organisations.

The first version of this document was submitted to CARACAL on 4 March 2013, with an invitation to submit comments. Written comments have been received from Belgium, Germany, Denmark, Finland, France, Slovakia, Switzerland, ANEC, BEUC, CEPE, EEB, ETUC, EUROMETAUX, NIA and UEAPME. Those comments, including a response from the Commission services are annexed to this version of the paper. They have also been taken into account in the terms of reference for a consultancy study which will support the Commission in this impact assessment.

The next steps on the impact assessment will be principally to gather information from existing notification schemes, in particular the French nanomaterial declaration scheme and notifications under the EU Cosmetics Regulation, and to draft the first parts of the impact assessment itself, in particular the problem definition and objectives, and to develop options for the impact assessment.

The purpose of document CA/14/rev1 is to inform on the progress of work and to give feedback to the comments. As it seems important to take into account the experiences from existing notification schemes and the first results of the study, it is not planned to continue revising this document but to draft a new consultation document once those results are available (for more details see sections 5 and 6 of this paper). Therefore, this document is for information only.

2.Methodology

The impact assessmentwill follow the methodology laid down in the Commission's Impact Assessment Guidelines. It will aim to identify and develop the most adequate means to increase transparency and ensure regulatory oversight for nanomaterials (“transparency measure”). Existing experiences from a similar existing or planned schemes at national or international level will be taken into account.

The Commission Impact Assessment System is a set of logical steps which helps the Commission to assess the potential economic, social and environmental consequences linked to proposed initiatives. The main steps laid down in the Impact Assessment Guidelines are summarized in the below table:

1 / Identifying the problem
  • Describe the nature and extent of the problem.

  • Identify the key players/affected populations.

  • Establish the drivers and underlying causes.

  • Is the problem in the Union's remit to act? Does it pass the necessity and value added test?

  • Develop a clear baseline scenario, including, where necessary, sensitivity analysis and risk assessment.

2 / Define the objectives
  • Set objectives that correspond to the problem and its root causes.

  • Establish objectives at a number of levels, going from general to specific/operational.

  • Ensure that the objectives are coherent with existing EU policies and strategies, such as the Lisbon and Sustainable Development Strategies, respect for Fundamental Rights as well as the Commission's main priorities and proposals.

3 / Develop main policy options
  • Identify policy options, where appropriate distinguishing between options for content and options for delivery mechanisms (regulatory/non-regulatory approaches).

  • Check the proportionality principle.

  • Begin to narrow the range through screening for technical and other constraints, and measuring against criteria of effectiveness, efficiency and coherence.

  • Draw-up a shortlist of potentially valid options for further analysis.

4 / Analyse the impacts of the options
  • Identify (direct and indirect) economic, social and environmental impacts and how they occur (causality).

  • Identify who is affected (including those outside the EU) and in what way.

  • Assess the impacts against the baseline in qualitative, quantitative and monetary terms. If quantification is not possible explain why.

  • Identify and assess administrative burden/simplification benefits (or provide a justification if this is not done).

  • Consider the risks and uncertainties in the policy choices, including obstacles to transposition/compliance.

5 / Compare the options
  • Weigh-up the positive and negative impacts for each option on the basis of criteria clearly linked to the objectives.

  • Where feasible, display aggregated and disaggregated results.

  • Present comparisons between options by categories of impacts or affected stakeholder.

  • Identify, where possible and appropriate, a preferred option.

6 / Outline policy monitoring and evaluation
  • Identify core progress indicators for the key objectives of the possible intervention.

  • Provide a broad outline of possible monitoring and evaluation arrangements.

The full Impact Assessment Guidelines can be found on:

In addition, the impact assessment will follow more detailed operational guidelines on assessing:

–administrative burden as provided for in an Action Programme for Reducing Administrative Burdens in the European Union{SEC(2007)84}[2]

–impacts on competitiveness ("Competitiveness Proofing Toolkit")[3]

–impacts on micro-enterprises[4]:

In general terms, this project will be pursued along the following logical steps:

2.1.Problem definition

In the Commission's understanding, the nature of the problem to be addressed are concerns about potentially inadequate action on health and environmental risks of nanomaterials and potentially suboptimal consumer choices as a result of lack of information being currently available to authorities,downstream user industries, distributers, workers and consumers. The problem to be addressed in this context is limited to issues related to the availability of information on the presence of nanomaterials and products containing nanomaterials on the market, in particular nanomaterials not covered by the current volume based registration obligations. Aspects related to hazard, exposure or risk assessment of nanomaterials are only covered indirectly because additionalinformationresulting from possiblemeasurescould lead to better targeted legislation or implementation of legislation.

The main potential users of information are public authorities and policy makers (who might take decisions on the risk management of certain substances to prevent health and environmental damage), downstream user industries and workers (who might improve risk management measures in the working environment), consumer and environmental associations (who might raise concerns on particular substances and applications) as well as consumers (who might make choices on whether or not to buy products containing nanomaterials). Potential beneficiaries of decisions made on the basis of the additional information will be consumers, workers, and the environment.

Several of the comments received make the link to the work on REACH Annexes. It seems a very valid question why this IA is limited to transparency measures like registries and webplatforms, while concerns about potentially inadequate action on health and environmental risks of nanomaterials and potentially suboptimal consumer choices could possibly be better addressed via improved risk assessment. Therefore, thought will need to be given how to link this Impact Assessment to the REACH Annex impact assessment (and its results which should be available in the later stages of the present impact assessment). Also, many concerns seem to be linked to the absence of information on nanomaterials manufactured at quantities below one tonne. While this is rather related to the adequacy of the tonnage thresholds under REACH rather than a specific new problem, this indicates a need for a discussion on this specific issue. This discussion would need to address the questions why the compromises found on tonnage thresholds under REACH are not adequate for nanomaterials. This does not seem to be straightforward, given that nanomaterials on average neither seem to be produced generally at lower quantity than other chemical substances nor do they seem generally more hazardous than other chemicalsubstances. In this context, the analysis of the data from the French notification systems will provide interesting insights. This analysis will flow into a new consultation document (for more details and planning see sections 5 and 6 of this document).

In the next step, it will be necessary to establish the extent of the potential problem, and in particular the level of information needed to enable public authorities, downstream user industries/workers/worker representatives and/or consumer/environmental organisations to take/propose appropriate risk management measures and to enable consumers to make informed choices. The extent of the problem will be influenced by the seriousness of potential risks and the likelihood that such risks could occur but also by the question whether and to what degree the information from a new transparency measure could be more appropriate to address those risks than existing information, as well as the likelihood that the new tool would indeed be used.

This involves a number of uncertainties, for which there is no absolute answer. Therefore, the level of information needed will ultimately be a political decision. Nevertheless, this level of information cannot be determined by absolute certainty and security, nor can it be based on existing knowledge only. Rather, this requires an evaluation of existing information, extrapolation and an informed estimation of potential risks. This should be done in line with the approaches recommended in the Commission Communication on the Precautionary Principle[5]:

"A scientific evaluation of the potential adverse effects should be undertaken based on the available data when considering whether measures are necessary to protect the environment, the human, animal or plant health. An assessment of risk should be considered where feasible when deciding whether or not to invoke the precautionary principle. This requires reliable scientific data and logical reasoning, leading to a conclusion which expresses the possibility of occurrence and the severity of a hazard's impact on the environment, or health of a given population including the extent of possible damage, persistency, reversibility and delayed effect. However it is not possible in all cases to complete a comprehensive assessment of risk, but all effort should be made to evaluate the available scientific information."[6]

The specific potential risks of nanomaterials seem, on the one hand, to be linked to the difference in properties compared to bulk materials, as well as their properties to pass biological barriers and possibly bio-accumulate. Some stakeholders argue that this is limited in practice as nanomaterials normally aggregate.A number of experimental studies demonstrate toxicological and ecotoxicological effects of certain nanomaterials above certain doses. Knowledge is far from being complete but knowledge on properties of nanomaterials has been steadily increasing over the past years. There are no indications that nanomaterials, on average, are more hazardous than other chemicals. Although some nanomaterials have been classified on certain endpoints, there is little evidence on serious incidents or epidemiological effects. There are specific uncertainties as regards their environmental fate and behaviour, related to the difficulty to measure nanoparticles in environmental media.

A particular aspect for the analysis will be the need for traceability of nanomaterials throughout the supply chain, as argued by some stakeholders. In the Commission's understanding, the need for traceability is based on the assumption that serious risks might occur that require immediate action to withdraw products from the market. To enable rapid market withdrawal this knowledge is needed about in which products the specific nanomaterial is contained. However, the responses on the consultation on the previous version of this document contained little elements that could give indications on the the seriousness and likelihood of such events.

Rather, it was argued that transparency and new information will enable more knowledge about nanomaterials and their uses, and allow a better assessment where exposure and risks might potentially occur in the workplace, during distribution and consumption, and at the end of life stage. According to some comments received, identification of products with potential exposure would allow better market surveillance. Nevertheless, it needs to be further worked out how this could be done concretely. The value added compared to e.g. testing of known products containing nanomaterials should be further investigated. Others argued that existing tools such as REACH, CLP and the Biocidal Product Legislation were likely to produce more useful results for risk and exposure assessment than a nanomaterial registry. Several comments received refer to the need for information in particular for nanomaterials manufactured or imported in quantities below the REACH 1 tonne registration threshold. It will need to be worked out why there is a specific need for such information for nanomaterials, compared to other chemicals (or whether there is a general need for such information for all chemicals). Moreover, there will be a need to quantify and compare the benefits of additional information and the burden to authorities and companies. This will be part of the impact assessment and will be partly based on the experiences from existing notification schemes.

Additionally, some comments argued that consumers, downstream user companies and workers need information whether products contain nanomaterials. In addition to ingredient labelling, a database should allow checking and traceability for consumers, companies and workers. This could also reduce possible misleading claims. Others questioned whether the information would be meaningful for consumers, and whether it would not rather mislead them, in particular in the absence of effective risk communication on nanomaterials. Others argued that the main use was not necessarily for consumers/workers but rather for their associations.

The Commission will develop a baseline scenario using the analysis of existing information made in the Commission Staff Working Paper on nanomaterial types and uses, including safety aspects[7] and assuming the continuation of measures already in place in the EU level. National measures already in place will be calculated separately, so there will be comparison with two situations, i.e. (1) with and (2) without considering existing national measures.

Additional drivers and underlying causes of discussions, such as emotions, perception, fear, rational or irrational market reactions and economic interests need to be analysed,and made transparentas far as possible.

Moreover, the Commission will need to identify whether there is a need and value-added for transparency measure(s) at Union rather than national level.

2.2.Objectives:

On the basis of the problem definition, the Commission will identify indicative level(s) of information needed[8] to address the problem, and set general and specific objectives to be attained in possible transparency measure(s).

The general objective of the initiative is to:

  • Reduce potential health and environmental risks and related negative impacts through increased knowledge about nanomaterials on the market and their uses.

This is achieved through better identification of possible exposure points by authorities, companies, workers and consumers, resulting from better traceability. It should be noted, though, that a potential registry will a priori not contribute to improved toxicological and ecotoxicological knowledge, nor to better knowledge about exposure levels. This could only be achieved by additional activities resulting from the identification of critical issues. It will need to be assessed, though, whether a registry would indeed create substantial new information in this respect and whether those additional activities could not already be taken on the basis of existing information about nanomaterials and their uses.