27 May 2016
European Commission Confirms Plan for Nano-Observatory
On 28 April 2016, the European Commission confirmed its plan to establish an EU nano-observatory. The main aim of the observatory would appear to be the making available of information that is clear and understandable, including information on hazards and risks related to nanomaterials.
The nano-observatory will, it is envisaged, compile information on nanomaterials from already-existing sources. This is felt to be preferable to imposing new information requirements on economic operators, according to information gained at a stakeholder meeting held on 26 April 2016 on the subject.
Traders may be relieved to learn that a nano-observatory was chosen over a ‘register’ as it was felt, in general, that registers create a high administrative burden while only marginally helping to improve risk assessment and management. This is because they are merely repositories for market information, rather than providing valuable information on hazards and risks. Moreover, consumers rarely obtain access to registers, therefore, in this sense (consumer awareness) they are considered ineffective as well. The Commission’s experience with registers thus far has been, it is reported, that they are not cost-effective tools.
At the meeting held on 26 April, it was noted that the observatory would be launched by the European Chemicals Agency (ECHA), between 2016 and 2019, together with a budget to run it.
On 3 May 2016, a member of the European Commission’s DG Grow confirmed that the final (official) decision on whether to launch the nano-observatory, which has not yet been made, will be taken after a Commission impact assessment has been finalised. Currently, there is no date set for the final decision. However, the Commission has carried out some preparatory work in anticipation of the approval of the nano-observatory.
In 2011, the EU adopted a definition of nanomaterial (see: Recommendation 2011/696/EU). According to the recommendation, a nanomaterial is “a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.” The Commission is currently reviewing this definition and it is expected to conclude its review in 2016.
Hong Kong manufacturers will likely know that nanomaterials are present in everyday consumer goods, such as clothing and shoes; cosmetic products including sun cream, deodorant and toothpaste; electronics and computers; home furnishings; household products including kitchen utensils; food and food packaging; sports equipment; and children’s toys and games.
Hong Kong companies exporting to several European countries may recall that, in particular, France, Belgium and Denmark have already established their own nano registers.
In France, nanomaterials must be registered through France’s national registration scheme. The scheme’s most recent annual report has recorded that the amount of nanomaterials registered in 2015 increased following declining results in the two preceding years. The increase in registrations indicates that more economic operators are aware of the obligation to register. It was recorded that, in France, more than 1,500 firms and other entities in the supply chain are reporting the production, import or distribution of nanomaterials.
The report showed that carbon black and silicon dioxide were the most produced or imported nanomaterials with quantities of over 100,000 tonnes recorded. Carbon black is commonly used in car products such as tyres, whereas silicon dioxide is often found in food. They were followed by calcium carbonate and titanium dioxide. It is further reported that ECHA has utilised the information recorded by the French nano register to identify REACH registration dossiers.
In Belgium, producers of substances and mixtures containing nanomaterials, and distributors to professional users, must register substances and mixtures containing nanomaterials. The Belgian definition of a nanomaterial is similar to the current EU definition, and there is an exemption for nanomaterials regulated by other laws such as biocides, medicinal products, food contact materials and animal feed.
Hong Kong businesses should take note that substances and mixtures currently on the Belgium market must be registered by 1 January 2017. Whereas, following 1 January 2016, any new substance and mixture must be registered before they can be placed on the Belgian market. The registration obligations are established in the Belgian nano register law of May 2014. Entries on the register will have to be updated in the first quarter of each year. Producers and distributors must provide information on the actual quantity of the registered substance or mixture placed on the market and a list of professional users who acquire the substance or mixture.
In Denmark, substances, and mixtures containing nanomaterials, produced or imported and placed on the Danish market had to be registered by 30 August 2015. Producers and importers of nanomaterials are required to provide information relating to the identity of the nanomaterial and the quantity of products or mixtures involved every year. If necessary, they can report additional information relating to the nanomaterial voluntarily. Denmark has also exempted the registration of food, feed, food contact materials, medical equipment, drugs, cosmetics, pesticides and waste-containing nanomaterials.
Hong Kong traders should bear in mind that the EU’s planned nano-observatory is to be a voluntary information platform whereas the nano registers already introduced by the three Member States are compulsory. Other EU Member States are not prevented from establishing their own nano registers.
On a final note, it should be emphasised that nanomaterials are currently already regulated by the EU’s REACH Regulation, due to the fact that they are covered by the definition of a chemical “substance” under REACH. The general obligations of REACH therefore apply as for any other substance, although there are no provisions (as yet) referring explicitly to nanomaterials.