The report of the advisory body to the German government for nano-technology, the NanoCommission, was published last month. It reflects the controversies surrounding the discussions on the regulation of nano-materials at EU-level.
The ‘NanoCommission' was established by the German government with a view to "contributing to a responsible approach to nano-technology by developing communication between operators of the technology development from science, economy and politics with societal operators". It is composed of representatives of environment and consumer organisations, a women and a physicians association, labour unions, churches and representatives of the federal government, as well as the governments of the Länder.
The report it published last month summarises the outcome of its second work phase between 2009-2010 and includes a chapter on "Regulation of nano-materials".
The document does not introduce new ideas or topics but is important as it reflects the main issues at stake within the context of nano regulation from the point of view of the largest member state of the EU.
The NanoCommission failed to reach consensus with respect to the definition of nanomaterial (see also our Bulletin article on the efforts on EU level to define nanomaterial) as well as the nano product register and labelling requirements. But the advisory body came up with recommendations for certain areas of legislation e.g. REACH, food, biocides, pesticides and cosmetics.
With respect to this biggest piece of chemicals legislation, the NanoCommission recommends adapting it in the context of the 2012 revision to the special requirements of nanomaterials, including adaption and update of the annexes and guidance documents.
In particular, the NanoCommission suggests revision of the following issues:
• Introduction of a definition of nano-material
• Adaption of data requirements for materials of nano-scale
• Further assessment and adaption of the OECD test methods and test strategies
• Provisions for the inclusion of nano-specific information in the SDS
• Transitional periods specific to the registration of nano-scale substances
• Assessment of the tonnage bands for a nano-specific assessment programme
No consensus was reached regarding:
• The general treatment of nano-materials as new substance (non phase-in)
• The lowering of the 0.1% threshold for nano-materials in articles
• Non-applicability of the exemptions provided for in Annexes IV and V to the nano-forms of the substances listed therein
• Status of a DU who turns a bulk material into a nano substance (i.e. whether he is regarded as a manufacturer under REACH?).
Biocides and pesticides
The current European legislation on biocidal and pesticidal products do not refer to nano-scale substances in a different way from bulk substances.
The NanoCommission recommends assessing whether the test methods used under EU legislation take the specific properties of nano-material sufficiently into account.
The new Regulation on cosmetic products (1223/2009/EC) contains a definition of nano-material and addresses nano-scale substances used in cosmetic products separately. When used as preservative, colorant or UV-filter, a separate application for the inclusion into the positive lists must be submitted. Furthermore, the Regulation requires an indication of the use of nano-scale substances on the product label behind the name of the relevant ingredient.
While the NanoCommission approves the approach taken in the new cosmetic product regulation, some of its members criticise the relatively narrow definition of nano-material in the regulation and the limitation of the application requirement to the categories of preservatives, colorants and UV-filters. Further, they point out that the regulation becomes effective only in 2013 which, in their opinion is too late in light of the quantity of nano products already on the market.
As reported by us earlier (Failure to approve Novel Food Regulation), the revision of the Novel Food Regulation (258/97/EC) did not take place due to disagreement between Parliament and Council on the requirements for nano-material.
Regarding food additives, the Food Additive Regulation (1333/2008/EC) regulates nano-materials that are used for technological reasons, for example as preservatives or colorants, and requires a new safety assessment and under certain circumstances a new approval if the food additive is intended to be used in a form in which it has not been previously tested.
Food contact materials are regulated in a framework regulation (1935/2004/EC) and a number of regulations referring to specific materials. It requires case-by-case assessment of new technologies including nano-technology.
The NanoCommission approved the above-mentioned regulations as a good basis for regulating nano-materials in food. However, no consensus was reached with regards to the definition of nano-material used for that purpose, labelling requirements, as well as specific nano-related test methods as a requirement for registrations.
No common position was reached by the NanoCommission in respect of the introduction of registers of products containing nano-materials. The NanoCommission discussed various objectives relating to such registers, such as:
• Transparency as to which products contain which nano-materials
• Traceability of nano-materials for the purposes of risk management measures taken by authorities, manufacturers and distributors (e.g. for re-call actions)
• Ensuring the freedom of choice for consumers i.e. choice between products containing or not containing nano-materials
Industry representatives referred to existing product lists and registers under EU law, in particular REACH, Cosmetics Regulation, food and biocides/pesticides legislation, and expressed their concern about duplicating existing notification requirements. Other representatives of the advisory board stressed the need for more transparency with respect to nano products on the market.
No recommendation was published by the NanoCommission as regards labelling requirements. Some stakeholders supported mandatory labelling requirements, as foreseen by the Cosmetic Products Regulation and as discussed in relation to the new Biocidal Product Regulation and Novel Food Regulation under review, for the purpose of informing consumers. Opponents of such requirements stressed the "warning effect" of a nano label which, they believe, is not justified if the product does not have hazardous properties.
While the NanoCommission agreed on few recommendations, a number of important issues did not lead to clear "Ja" or "Nein" answers of the advisory board. The NanoCommission will pursue its work; stakeholders are well advised to monitor its discussions and recommendations.